Rejuvenate Total Hip System Surgical Protocol Rejuvenate Modular Hip Stem • Enhanced Stability1 • Proven Modularity2 • Intraoperative Flexibility Rejuvenate Total Hip System Surgical Protocol Table of Contents Indications, Contraindications, & Precautions .............................. 1 System Overview .............................................................................. 1 Preoperative Planning and X-Ray Evaluation ................................ 2 Identifying the Proximal Femoral Shaft Axis .................................. 2 Step 1 – Femoral Neck Resection...................................................... 2 Step 7 – Trial Reduction Off Stem .................................................. 9 Modular Stem Option Only .................................................... 9-11 Step 8 – Neck and Head Implantation .......................................... 12 Step 2 – Preparing The Femoral Canal ...................................... 3-4 Appendix C – Modular Instrument Component Diagram ...... 14 Step 3 – Broaching the Femur............................................................ 5 Appendix D – Implant Catalog Numbers and Stem Lengths .... 15 Step 4 – Calcar Planing .................................................................... 6 Step 5 – Trial Reduction Off Broach .............................................. 6 Monolithic Stem Option ................................................................ 6 Modular Stem Option ...................................................................... 7 Appendix E – Offset Chart and Acceptable Head/Neck Combination Tables ................................................ 16 Step 6 – Stem Implantation ................................................................ 8 Appendix H – Component Compatibility .................................... 20 Appendix A – Options: Modular Neck Extraction .................... 14 Appendix B – Options: Stem Extraction ...................................... 14 Appendix F – Instrument Catalog Numbers .............................. 17 Appendix G – Neck Implant Decision Algorithm ...................... 19 Surgeon Contributors: William N. Capello, M.D. Indiana University School of Medicine Indianapolis, IN Joseph J. Jankiewicz, M.D. Sharps-Reely Hospital San Diego, CA Lawrence G. Morawa, M.D. Oakwood Hospital Dearborn, MI James P. Crutcher, M.D. Swedish Medical Center Seattle, WA James Kudrna, M.D., PhD University of Chicago Pritzker School of Medicine Chicago, IL Joseph P. Nessler, M.D. St. Cloud Hospital St. Cloud, MN James A. D’Antonio, M.D. University of Pittsburgh Pittsburgh, PA, Graham N. Gitlin, M.D. Cedars Sinai Medical Center Los Angeles, CA Kenneth A. Greene, M.D. Northeastern Ohio University College of Medicine Rootstown, OH Michael A. Masini, M.D. St. Joseph Mercy Hospital Ann Arbor, MI Joseph C. McCarthy, M.D. Massachusetts General Hospital Boston, MA Phillip O. Merritt, M.D. Glendale Adventist Medical Center Glendale, CA James Scott, M.D. Tifton General Hospital Tifton, GA Brett R. Smith, M.D. Allegheny General Hospital Pittsburgh, PA Daniel Ward, M.D. New England Baptist Hospital Chestnut Hill, MA This publication sets forth detailed recommended procedures for using Stryker® Orthopaedics devices and instruments. It offers guidance that you should heed, but, as with any such technical guide, each surgeon must consider the particular needs of each patient and make appropriate adjustments when and as required. Preoperative Templating The Rejuvenate Femoral Platform includes a complete set of both acetate (120% magnification) and digital femoral templates. Acetabular Options Conditions presenting increased risk of failure include: 1)uncooperative patient or patient with neurologic disorders, incapable of following instructions; Stryker offers a wide variety of acetabular components that are compatible with the Rejuvenate Total Hip System. The surgeon should refer to the specific acetabular component’s surgical technique for a discussion of acetabular surgical procedures. 2)osteoporosis; Surgical Approaches Patients should be warned of these contraindications and risks. Each surgeon should use the surgical approach for total hip arthroplasty with which he or she is most familiar. Patient positioning, prepping and draping, the skin incision, soft tissue dissection, and hip dislocation are performed according to the surgeon’s preferred technique, making certain to adequately expose the acetabulum and the proximal femur. The Rejuvenate Total Hip System accommodates most well-established surgical approaches. See the package insert for warnings, precautions, adverse effects and other essential product information. Indications The indications for use of total hip replacement prostheses include: 1)noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2)rheumatoid arthritis 3)correction of functional deformity; 4)revision procedures where other treatments or devices have failed; and, 5)treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. 6)Stryker’s REJUVENATE Modular Hip System is intended for cementless use only. Contraindications 3)metabolic disorders which may impair bone formation; and, 4)osteomalacia. System Overview The Rejuvenate Femoral Platform is a modular primary hip system of femoral stems and necks that provide surgeons with options for personalizing the implant to each patient’s anatomy and biomechanical needs. The fixation philosophy is built upon the clinically successful Stryker hip stems. The Rejuvenate femoral stem represents the latest evolution in the OmniFit and Secur-Fit product lines, which has a successful published clinical history.3 The Rejuvenate stem bodies are made of TMZF alloy, a proprietary Stryker material with a plasma sprayed coating of commercially pure (CP) titanium and PureFix HA. The modular necks are made of CoCr alloy. The Rejuvenate femoral instrumentation consists of unique hip instruments. The design of the Rejuvenate instrumentation incorporates suggestions and feedback from an esteemed panel of orthopaedic surgeons, as well as key staff members from the operating room (OR) and central supply. The broach contours the proximal femur to the geometry of the stem to provide a complimentary fit of the stem to the bone. The broaches are designed with a series of teeth that are intended to seat against highly densified cancellous bone for the interference press-fit in the uncemented application. Absolute contraindications include: 1)overt infection; 2)distant foci of infections (which may cause hematogenous spread to the implant site); 3)rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram; 4)skeletally immature patients; and, 5)cases where there is a loss of abductor musculature, poor bone stock, or poor skin coverage around the hip joint which would make the procedure unjustifiable. 1 Preoperative Planning and X-Ray Evaluation Preoperative planning aids in the selection of the most favorable implant style and size for the patient’s hip pathology. Optimal femoral stem fit, prosthetic neck length, angle and version can be more closely evaluated with the use of preoperative x-ray analysis. The following parameters should be determined using an A/P radiograph: Stem Size Femoral Offset Leg Length Neck Angle Center of Rotation 1 Trochanteric Fossa Proximal Femoral Axis Determination of the probable implant size can facilitate operating room preparation and assure availability of an appropriate size selection. Preoperatively, an x-ray with analysis markings can be valuable in identifying the appropriate neck resection level (see below). Anatomic anomalies that could prevent the intra-operative achievement of the established preoperative goals may also be detected. The Pelvic Alignment Level (PAL) is an optional, single use, sterile hip position reference system that is available for use during THR. The use of the PAL (cat. no. PAL-400) aids the surgeon to recognize and understand the impact of intraoperative pelvic motion, and is designed to optimize acetabular alignment, reduce the chance for post-operative dislocation and restore femoral leg length and offset. 2 Scale on Resection Guide corresponds to scale on the templates Identifying the Proximal Femoral Shaft Axis 39° Neutral alignment of a straight stem design requires the identification and preparation of the proximal femoral shaft axis. The trochanteric fossa, a reliable landmark for identifying the proximal shaft axis, must be unobstructed during preparation to permit true axial reaming (Figure 1). Using the Resection Guide to determine resection point based on lesser trochanter 1 Femoral Neck Resection Lay the Stryker Femoral Resection Guide (Figure 2) on the femur, using the lesser trochanter and the trochanteric fossa as landmarks when making the final cut. Care should be taken to align the axis line of the Neck Resection Guide to the center axis of the femoral shaft; the scales on the lateral flange or medial radius of the guide can be used to reference the greater or lesser trochanter respectively when making the final cut. 2 39° Neck resection angle Tip The Resection Guide has a threaded hole in the center that allows attachment to the modular Head and Neck Impactor shaft to facilitate use in a small operative field. 2 Preparing The Femoral Canal 3 Retraction of the gluteus medius and removal of a portion of the medial aspect of the greater trochanter will permit true axial introduction of the instruments and prostheses. A Box Osteotome is useful in removing bone from this area. Connect the Box Osteotome attachment to the Modular Handle. Use a Mallet to strike the end of the Modular Handle with careful controlled blows to remove remnants of the superior femoral neck and open the medullary canal (Figure 3). Reposition the Box Osteotome if further bone removal is desired. Disconnect the Box Osteotome attachment from the Modular Handle immediately after use. Tip A clear-out hole has been placed on the back of the Box Osteotome that allows bone to be removed using a Curette or other OR instruments in an action that does not require a force to be directed at the cutting surface. 4 Starter Reamer The Starter Reamer can be used to enter the femoral canal through the trochanteric fossa. The Starter Reamer has a point to facilitate entry and graduated markings along the shaft that correspond to implant sizes. Enter the canal with the Starter Reamer attached to either a T-handle or powered instrument. Place the Starter Reamer on the exposed trochanteric fossa and proceed down into the shaft along its axis to the appropriate depth. The Starter Reamer should be inserted such that the appropriate marking corresponding to the preoperatively selected stem size correlates to the depth of the medial resection point (Figure 4). Tip Depth markings on the Starter Reamer, which correspond to the Tapered Reamer depth for each stem, should be aligned with the medial aspect of the resection plane. Reamer Depth 12 10-11 8-9 6-7 5 4 Medial Resection Point 3 Trochanteric Reaming Select and use the appropriate Trochanteric Reamer to remove lateral proximal cortical bone. This will further assist in establishing proper axial alignment. 5 The Trochanteric Reamer is available in standard and large sizes. The Reamer should be inserted to a depth such that the distal end of the cutting flutes aligns with the medial resection point (Figure 5). Each Trochanteric Reamer is designed to prepare for three stem sizes. See Table 1. Medial Resection Point Option For Sizes 4-6, the standard Trochanteric Reamer is optional and to be used according to surgeon’s discretion. Table 1: Recommended Trochanteric Reamer Sizes Stem Size Tapered Reamer 7-9 Standard Trochanteric Reamer 10 - 12 Large Trochanteric Reamer 6 Size 7 Broach Only Option Size 8 The fully toothed Broaches may facilitate preparation of the femoral canal without the use of Tapered Reamers. However, a narrow/tight diaphyseal shaft (e.g. champagne flute femur) may result in broach resistance in the distal canal. If resistance is encountered, tapered reaming is recommended to minimize potential for distal femoral fractures. If the Broach does not seat at the desired height, ream upward until the Broach seats at the desired height. The option to skip any reaming step is at the discretion of the surgeon. Proceed to the next page for instructions on broaching. Tapered Reaming Implant size is determined through templating and broaching. Reamers are used to prepare the canal distally where dense cortical bone exists, thereby aiding in broaching. Ream sequentially upward to one size under the templated size (Figure 6). Note that although final implant size will be determined via broaching, the last Tapered Reamer should be equal to or smaller than the final implant. See Table 2 for a list of recommended Reamer sizes for each stem. Table 2: Recommended Tapered Reamer Sizes Stem Size Tapered Reamer 5 5-6 6 5-6 7 7-8 8 7-8 9 9 - 10 10 9 - 10 11 11 - 12 12 11 - 12 Note For size 4, Starter Reamer acts as Tapered Reamer. Tip If preoperative templating results in an in-between size, ream to smaller size. 4 Caution Reamers are sharp and aggressive. 3 Broaching The Femur 7 Assemble the Broach to the Broach Handle by inserting the alignment tab on the distal end of the Broach Handle into the Broach (Figure 7). Closing the locking arm until an audible click is heard secures the Broach onto the Broach Handle. Using a Mallet with short, controlled strokes, begin broaching and sequentially broach up until the desired size is reached. Throughout broaching, continue to apply lateral pressure to ensure neutral alignment of the implant. Quick Release Button Correct fit will be denoted by a change in pitch or tactile resistance. To verify a secure fit, attempt to rotate the Broach relative to the femur. With proper cortical contact, the Broach should not twist or move relative to the femur. If there is movement, a larger size broach may be needed. Locking Arm Locking Hook Tip Alignment Tab The Stem Impactor can also be used with the Broach Handle to serve as a version guide (Figure 8). The fitting end of the Stem Impactor is inserted into the top hole in the Broach Handle. The Stem Impactor can be held in place while holding the Broach Handle. Alternately, the Modular Handle can be connected to the Stem Impactor/Version Bar fitting to provide greater torsional control. Broach 8 The final Broach should seat tightly in the femoral canal. The Broaches are designed to seat to the same level as the implant, allowing neck trialing to be performed directly off of the Broach. However, it may be preferable to trial directly off of the implanted stem. The Rejuvenate Broaches and Stems are designed to produce a press-fit gradient (Figure 9). This approach to press-fit design allows for easier insertion, while enabling initial stability of the stem. Once optimal fit is achieved, remove the Broach Handle and proceed to Step 4. Optional Trial reduction can be performed using the Broaches. However, it is recommended that for the Modular Implants, trial reduction be performed with the Modular Implant to maximize procedure accuracy. 9 Caution Proper insertion depth of the Broach in the canal is achieved when it seats tightly within the canal based on visual and auditory clues. The surgeon’s clues to firm implant fixation include increased pitch of sound with blows to Broach Handle and increased resistance to advancement. Reliance only on the neck cut may lead to improper sizing, inadequate component fixation, and femoral fracture. 0.125mm press-fit per side Press-fit gradient to end of Plasma Spray region Line to line Note Regular lubrication of Broach Handle is recommended. 5 4 Calcar Planing 10 Calcar planing creates a final resection plane and angle to optimize stem fit. There are two Calcar Planers in the set (standard, large). Select the size that fits the cut surface of the neck. Each Calcar Planer includes a spring-loaded alignment tab that provides controlled alignment and engagement with the Broach (Figure 10). Align the tab within the Broach body, initiate power and press down to plane the calcar to desired level. Calcar Planer Alignment Tab Note Calcar Planer removes less than 4mm of bone. Bone remnants can be removed from the Calcar Planer to continue calcar planing. 11 Note Neck Trial Regular lubrication of Calcar Planers is recommended. Neck Angle 132° Caution Neck Angle 127° Failure to operate the Calcar Planer in accordance with the instructions above may result in damage to the femur. Neck Angle Direction Monolithic Stem Option On the inferior and superior surfaces: The neck angle marking facing superiorly represents the angle in use Neck length Snap the V40 Head Trial onto the Neck Trial. Perform trial reduction. After identifying the appropriate head and neck, remove the Head and Neck Trials from the Broach. Color Coding Version Degrees Face of Neck Trial Note If neck angle direction arrow points superiorly #, neck angle is 132° as shown on superior neck angle marking. If neck angle direction arrow points inferiorly $, neck angle is 127° as shown on superior neck angle marking. Table 3: Monolithic Stem Neck and Head Trial Choices Monolithic Stem Monolithic Stem Guidelines For body size 4, do not use femoral head offset greater than +8mm. For body size 5, do not use femoral head offset greater than +12mm. For body size 6, do not use femoral head offset greater than +12mm. Table 3 lists the permissible stem/neck and head combinations for the Monolithic Stems. Use contrary to these specifications will negate the responsibility of the device manufacturer. Broach Removal Attach the Broach Handle to the Broach and extract using a Mallet. Proceed with stem insertion and final trial reduction (See Step 6). 6 0° ° 127 There are three monolithic Rejuvenate Stem sizes offered. Trialing is performed off the Broach with the appropriate Neck and Head Trials. Select the appropriate 0° Neck Trial, based on the pre-operative plan and templating (refer to Table 3). The 0° Neck Trial is labeled with the following information: On the end of the trunnion: 0° version degree Arrow indicating neck angle direction Black color coding dot 132° Neck Angle 5 Trial Reduction Off Broach Stem Size Neck Angle Neck Length Maximum Femoral Head Offset Max Head and Neck Combined Length 4 132° 26mm +8mm 34mm 5 132° 26mm +12mm 38mm 6 132° 26mm +12mm 38mm 6 127° 30mm +12mm 42mm Note Size 6 is the only monolithic stem available with 127° neck angle. Modular Stem Option Select a Neck Trial, based on the pre-operative plan and templating (refer to Decision Algorithm in Appendix G). The Neck Trial is labeled with the following information: 12 Neck Trial Neck Angle 132° On the end of the trunnion: Version degrees Arrow indicating version and neck angle direction Color coding dot indicating version Neck Angle 127° On the inferior and superior surfaces: The neck angle marking facing superiorly represents the angle in use Neck length Modular Stem - Modular Neck & Modular Head Guidelines Total Head & Neck Construct Length = Head Offset + Modular Neck Length. Table 4 below lists the permissible stem/neck and head combinations. Appendix E lists permissible femoral head offsets. Deviation from these specifications may affect the structural integrity of the neck-stem modular junction. Use contrary to these specifications will negate the responsibility of the device manufacturer. 132° Neck Angle Direction Version Direction Color Coding Version Degrees 8° ° 127 Once the neck length requirements are established, select a Neck Trial with the necessary version and varus/valgus orientation that best reproduces patient biomechanics based on the pre-operative plan (refer to Neck Trial Option Chart on page 11). Insert the Neck Trial into the Broach (Figure 12). The Neck Trial will snap into place. Snap the V40 Head Trial onto the Neck Trial. Perform trial reduction. After identifying the appropriate Head and Neck, remove the Head and Neck Trials from the Broach. Neck Angle Face of Neck Trial Note If neck angle direction arrow points superiorly #, neck angle is 132° as shown on superior neck angle marking. If neck angle direction arrow points inferiorly $, neck angle is 127° as shown on superior neck angle marking. Total Head & Neck Construct Length Table 4: Max Total Head and Neck Construct Length per Version Stem Size Version 7 8 9 10 11 0° 46* 46* 46* 46* 46* 8° 46* 46* 46* 46* 46* 16° 38 38 42 46* 46* * Achieved only by combining a Modular Neck with a head offset greater than +0mm. 12 46* 46* 46* Neck Length Head Offset Refer to Appendix E for Acceptable Head/Neck combinations and Appendix H for Component Compatibility. Tip Keep the last Neck Trial that was used captured in the Neck Trial Forceps. This will allow a secondary method of confirming the desired neck implant. Total Head Modular & Neck Head Construct = Offset + Neck Length Length Broach Removal Attach the Broach Handle to the Broach and extract using a Mallet. Proceed with stem insertion and final trial reduction (See Step 6). 7 6 Stem Implantation 13a Option 1: Stem Inserter The Rejuvenate Femoral Platform offers two instrument options to insert the monolithic and modular stems (Figure 13): Option 2: Stem Impactor Note Prior to proceeding with stem implantation, the surgeon should follow the standard procedure for femoral canal preparation, including proper irrigation. Locking Arm Modular Handle Option 1: The Rejuvenate Stems all have an insertion feature that consists of a non-threaded hole with a version-control keyway on the top surface of the proximal body. The Stem Inserter uses a metal collet that expands inside the insertion feature to form a secure connection with the stem facilitating stem insertion and version control. To attach a stem, open the Stem Inserter's locking arm completely, place tip of Inserter completely into the insertion feature and ensure proper seating of the key in the keyway. While holding the stem in position, close the locking arm of the Inserter to the “closed” position as shown in (Figure 13a). 30° Max Stem Impactor Do not exceed a greater than 30° impacting angle from the axis of the stem Proceed with stem insertion while firmly griping the locking arm. Use a Mallet with short, controlled strokes to seat the implant. Typically, the final implant is seated when the proximal edge of the plasma spray is even with the resection level (Figure 13b). Note Do not impact Stem Inserter if it is not completely seated in the insertion feature. The Inserter is completely seated in the stem insertion feature when the face of the Inserter is flush with the top surface of the stem body and the Inserter’s version key is placed fully in the stem’s keyway. 13b Resection Level Option 2: For surgeons who prefer off-axis stem impaction, the Rejuvenate Femoral Platform also includes a modular Stem Impactor. The Stem Impactor has unique distal geometry designed to allow impaction against the insertion feature. To prepare the Impactor for use, attach to the Modular Handle. Proceed with stem insertion. Use a Mallet with short, controlled strokes to seat the implant. Typically, the final implant is seated when the proximal edge of the plasma spray is even with the resection level (Figure 13b). Note Use of off-axis Stem Impactor could potentially alter geometry of insertion feature, thus not allowing subsequent use of Stem Inserter on Modular Stem. Caution Caution The Stem Impactor does not capture the stem. Care should be taken to prevent it from slipping off the stem and damaging the trochanter. For best results, use short controlled mallet strokes. Do not exceed an angle of 30° from the axis of the stem. 8 The surgeon should NOT attempt to continue impacting the femoral component if visual and auditory clues indicate that the resting position of the femoral component has been reached. This can be true even if the femoral component is not yet down to the level of the Broach. Continued aggressive impaction may lead to femoral fracture. 7 Trial Reduction Off Stem 14 Neck Trial Adapter Modular Stem Option Only The Rejuvenate stem is prepackaged with a Neck Trial Adapter. This Adapter provides an interface between the Stem and the Neck Trial. This Adapter remains in the Stem throughout trial reduction. Select a Neck Trial, based on the pre-operative plan and templating (refer to Decision Algorithm in Appendix G). The Neck Trial is labeled with the following information: On the end of the trunnion: Version degrees Arrow indicating version and neck angle direction Color coding dot indicating version Neck Trial Modular Stem On the inferior and superior surfaces: The neck angle marking facing superiorly represents the angle in use Neck length 132° Neck Angle Neck Angle Direction Neck Angle 132° Neck Angle 127° Version Direction Color Coding Version Degrees 8° ° 127 Once the neck length requirements are established, select a Neck Trial with the necessary version and varus/valgus orientation that best reproduces patient biomechanics based on the pre-operative plan (refer to Neck Trial Option Chart on page 11). Insert the Neck Trial into the Adapter (Figure 14). The Neck Trial will snap into place. Snap the V40 Head Trial onto the Neck Trial. Perform trial reduction. After identifying the appropriate Head and Neck, remove the Head and Neck Trials from the Adapter. Modular Stem - Modular Neck & Modular Head Guidelines Face of Neck Trial Total Head & Neck Construct Length = Head Offset + Modular Neck Length. Table 4 below lists the permissible stem/neck and head combinations. Appendix E lists permissible femoral head offsets. Deviation from these specifications may affect the structural integrity of the neck-stem modular junction. Use contrary to these specifications will negate the responsibility of the device manufacturer. Note If neck angle direction arrow points superiorly #, neck angle is 132° as shown on superior neck angle marking. If neck angle direction arrow points inferiorly $, neck angle is 127° as shown on superior neck angle marking. Total Head & Neck Construct Length Table 4: Max Total Head and Neck Construct Length per Version Stem Size Version 7 8 9 10 11 0° 46* 46* 46* 46* 46* 8° 46* 46* 46* 46* 46* 16° 38 38 42 46* 46* * Achieved only by combining a Modular Neck with a head offset greater than +0mm. 12 46* 46* 46* Refer to Appendix E for Acceptable Head/Neck combinations and Appendix H for Component Compatibility. Tip Neck Length Head Offset Total Head Modular & Neck Head Construct = Offset + Neck Length Length Keep the last Neck Trial that was used captured in the Neck Trial Forceps. This will allow a secondary method of confirming the desired neck implant. 9 Neck Trial & Implant Labeling Convention The modular Neck Trials are stored in a color-coded caddy, organized by length, within the instrument set tray. Each Trial has a color dot on the end of the trunnion to correspond to the color and description on the Neck Trial Caddy (Figure 15). 15 Neck Trial Caddy Once trial reduction is complete, the surgeon can request the appropriate Modular Neck using neck length and color code. This will provide sufficient information with which to identify the correct implant. On the package label is the Modular Neck catalog number. That number includes the implant length, the amount of version and the color code letter. Once the package is opened and the Modular Neck is removed, the implant is labeled on the trunnion with taper type, implant length and amount of version as well as arrows indicating version direction and neck angle. Green Dot Neck Trial Neck Implant The example at right demonstrates the labeling convention for a 38mm Modular Neck with 132° neck angle and 8° of anteversion for use in a right hip. This implant has the green color code (refer to Neck Trial Option Chart on page 11). Neck Trial Adapter Removal Insert the Adapter Removal tool into the Neck Trial Adapter and squeeze the handle (Figure 16). Remove the Adapter from the Stem and discard immediately. Face of Neck Implant Neck Angle Direction Ensure that neither soft tissue nor any other material has entered the stem taper after removal of the Adapter, and prior to implantation of the Modular Neck. The Stem is now ready to receive a Neck Implant. Version Direction 8° Version Trunnion Taper V40 38mm 8°G Neck Length “G”-Green Note The Adapter is radiopaque for visualization under X-ray. The Adapter is intended only for single-use. DO NOT attempt to reuse. If needed, adapters are available as single, sterile packaged pieces (cat. no. 1601-2000). Catalog No. NLV-380800G Neck Angle 132° Caution Neck Angle 127° Do not apply torsional force to Adaptor during removal. 16 Neck Trial Adapter Removal Tool 10 Illustration of Neck Trial and Neck Implant for Right / Left Hip Right Hip Right Hip 132° Neck Angle 8° Anteversion Trial Left Hip Left Hip 127° Neck Angle 8° Anteversion Implant Anteverted Implant Trial Anteverted 8° 30mm 8°G V40 V40 30mm 8°G 8° Face of Neck Implant Face of Neck Trial Right Hip 127° Neck Angle 8° Retroversion Trial Implant Face of Neck Trial Face of Neck Implant Left Hip 132° Neck Angle 8° Retroversion Trial Implant Retroverted Retroverted 8° 30mm 8°G V40 V40 30mm 8°G 8° Face of Neck Trial Face of Neck Implant Face of Neck Implant Face of Neck Trial Note Four boxes above demonstrate how the Neck Trial and the Neck Implant can be used in the right and left hip. Neck Trial Caddy Neck Trial Option Chart 16° Retro Purple 127° 8° Retro Green 132° 8° Retro Yellow 127° 0° Neutral Black 132° 0° Neutral Black 127° 8° Ante Yellow Right Hip 16° Retro Purple 132° 8° Ante Green 16° Ante Purple 127° 8° Retro Yellow 132° 8° Retro Green 127° 0° Neutral Black 132° 0° Neutral Black 127° 8° Ante Green Left Hip 132° 8° Ante Yellow 16° Ante Purple 11 8 Neck and Head Implantation Attach the Modular Handle to the Neck and Head Impactor (Figure 17). The inside of the tip of the Neck and Head Impactor is specially shaped to accept the trunnion of the Neck. Place the Modular Neck into the Modular Stem using the arrows indicating neck angle and version angle as a guide. Impact the Modular Neck into the Modular Stem. Two moderate Mallet blows are sufficient. Impact the Head onto the Modular Neck. 17 Modular Handle Neck and Head Impactor If utilizing a Cobalt Chrome Head, select the appropriate size and place it onto the dry trunnion of the Femoral Stem with a slight twist. Impact the Head with two moderate blows using the Neck and Head Impactor. If utilizing a BIOLOX delta ceramic Head, the appropriate size is intraoperatively assembled to the Neck and is seated with about two moderate blows using the Neck and Head Impactor. Care must be taken to avoid excessive impaction forces when assembling the ceramic Head to the Neck. Verify the Head is secure on the trunnion after impaction. If necessary, the Head can be removed utilizing the head disassembly instrument.* Note Neck and Head Impactor does not hold the Neck or Head. Reduce the joint and close Relocate the Femoral Head into the Acetabular Cup and check the stability and range of motion. The surgical site is then closed according to the standard procedure for the surgical approach chosen. A fully seated neck implant in the Modular Stem Postoperative care Postoperative care should progress according to surgeon preference and recommendation. * If a BIOLOX delta ceramic Head is placed on the trunnion and then removed, it must be replaced with a V40 Cobalt Chrome head, a V40 Titanium Adapter Sleeve (17-0000E) and a C-Taper ceramic Head or a V40 Universal Adapter Sleeve and a BIOLOX delta Universal Taper ceramic Head. Note If Universal Head is selected, impact Modular Neck to Stem before placing Universal Adapter Sleeve on Neck. Note Alumina ceramic femoral Heads cannot be used directly on the Cobalt Chrome Modular Neck and require the use of a Titanium V40 Adapter Sleeve (17-0000E) to convert the V40 stem trunnion to C-Taper. OPTIONAL STEP NOTE: When selecting a BIOLOX delta Universal Taper Ceramic Femoral Head for implantation with Rejuvenate, use of a V40 Universal Adaptor Sleeve is necessary (Table 5). Table 5: Universal Adaptor Sleeves Universal Adaptor Sleeve Part Numbers Taper Stem Material Compatibility 19-0XXXT C-Taper TMZF, Ti-6Al-4V, CoCr 6519-T-XXX V40 TMZF, Ti-6Al-4V, CoCr After completing the trialing process, intraoperatively assemble the Adaptor Sleeve to the Femoral Stem manually. The Universal Adaptor Sleeve must be fully seated on the Stem trunnion before the Head is assembled. NOTE: In no instance should any attempt be made to pre-assemble the Adaptor Sleeve inside the BIOLOX delta Universal Ceramic Head. Intraoperatively assemble the BIOLOX delta Universal Taper Ceramic Head onto the sleeved Femoral Stem and set with one to three moderate blows using the Stem Head Impactor (1104-1000). Care must be taken to avoid excessive impact forces when assembling the Ceramic Head to the sleeved femoral component. 12 APPENDICES Table of Contents Appendix A – Options: Modular Neck Extraction................................................................................................................................................ 14 Appendix B – Options: Stem Extraction ................................................................................................................................................................ 14 Appendix C – Modular Instrument Component Diagram ................................................................................................................................. 14 Appendix D – Implant Catalog Numbers and Stem Lengths .................................................................................................................................. 15 Appendix E – Offset Chart and Acceptable Head/Neck Combination Tables...................................................................................................16 Appendix F – Instrument Catalog Numbers ......................................................................................................................................................... 17 Appendix G – Neck Implant Decision Algorithm ................................................................................................................................................. 19 Appendix H – Component Compatibility............................................................................................................................................................... 20 13 Appendix A Options: Modular Neck Extraction The Neck Implant is removed with the use of the Rejuvenate Neck Extractor (Figure 18). The Neck Implant is extracted by placing the Neck Extractor under either the medial or lateral side of the base of the Neck and levering out the Neck. Neck Trial Forceps are recommended to capture the neck during extraction. Tip Tap end of Neck Extractor with a Mallet to remove Neck in a controlled manner. 18 Appendix B Options: Stem Extraction There are instruments to manage the extraction of a Monolithic or Modular Stem in both intraoperative and revision situations (Figure 19). The Modular Stem Extractor uses a connection pin, which engages the stem insertion feature and a locking arm that engages the Modular Stem taper. The arm is secured in place using a threaded locking knob. The proximal end of the instrument attaches to a McReynolds Extractor Assembly (6869-1-000, 6869-2-000, 68693-000) to provide the surgeon with a tool to facilitate the removal of a well-fixed Femoral Stem. The Modular Stem Extractor should be reseated and retightened after four extraction blows. The Monolithic Stem can be extracted with the McReynolds Distal Stem Adapter (6260-4-090) and McReynolds Driver (6869-1-000, 6869-2-000, 6869-3-000) from the Restoration Modular Instrument System. Caution Neck Trial Forceps Neck Extractor Do NOT impact the Locking Knob of the Modular Stem Extractor as this could damage it. Note The Stem Inserter should not be used to extract the Stem. Neck Implant 19 Monolithic Stem Extraction Modular Stem Extraction Appendix C Modular Instrument Component Diagram McReynolds Extractor Assembly 20 Box Osteotome Stem Impactor Modular Handle Locking Knob McReynolds Distal Stem Adapter Head/Neck Impactor Extractor Locking Arm Tip Ensure instrument is fully seated in the Modular Handle before use. 14 Extractor Connection Appendix D Implant Catalog Numbers and Stem Lengths Table 6: Monolithic Stem, Modular Stem and Modular Neck Implants Monolithic Stems Cat. No. Rejuvenate Straight Press-fit Texture TMZF Monolithic Stem, Size 4, 132° SPT-043100S Rejuvenate Straight Press-fit Texture TMZF Monolithic Stem, Size 5, 132° SPT-053200S Rejuvenate Straight Press-fit Texture TMZF Monolithic Stem, Size 6, 132° SPT-063400S Rejuvenate Straight Press-fit Texture TMZF Monolithic Stem, Size 6, 127° SPT-063800S Modular Stems Cat. No. Rejuvenate Straight Press-fit Texture TMZF Modular Stem, Size 7 SPT-070000S Rejuvenate Straight Press-fit Texture TMZF Modular Stem, Size 8 SPT-080000S Rejuvenate Straight Press-fit Texture TMZF Modular Stem, Size 9 SPT-090000S Rejuvenate Straight Press-fit Texture TMZF Modular Stem, Size 10 SPT-100000S Rejuvenate Straight Press-fit Texture TMZF Modular Stem, Size 11 SPT-110000S Rejuvenate Straight Press-fit Texture TMZF Modular Stem, Size 12 SPT-120000S Modular Necks Cat. No. Rejuvenate Modular Neck, 30mm, 0°, 127°/132°, Black NLS-300000B Rejuvenate Modular Neck, 30mm, 8° AV/RV, 127°/132°, Yellow NLV-300800Y Rejuvenate Modular Neck, 30mm, 8° RV/AV, 127°/132°, Green NLV-300800G Rejuvenate Modular Neck, 30mm, 16° RV/AV, 130°, Purple NLS-301600P Rejuvenate Modular Neck, 34mm, 0°, 127°/132°, Black NLS-340000B Rejuvenate Modular Neck, 34mm, 8° AV/RV, 127°/132°, Yellow NLV-340800Y Rejuvenate Modular Neck, 34mm, 8° RV/AV, 127°/132°, Green NLV-340800G Rejuvenate Modular Neck, 34mm, 16° RV/AV, 130°, Purple NLS-341600P Rejuvenate Modular Neck, 38mm, 0°, 127°/132°, Black NLS-380000B Rejuvenate Modular Neck, 38mm, 8° AV/RV, 127°/132°, Yellow NLV-380800Y Rejuvenate Modular Neck, 38mm, 8° RV/AV, 127°/132°, Green NLV-380800G Rejuvenate Modular Neck, 38mm, 16° RV/AV, 130°, Purple NLS-381600P Rejuvenate Modular Neck, 42mm, 0°, 127°/132°, Black NLS-420000B Rejuvenate Modular Neck, 42mm, 8° AV/RV, 127°/132°, Yellow NLV-420800Y Rejuvenate Modular Neck, 42mm, 8° RV/AV, 127°/132°, Green NLV-420800G Rejuvenate Modular Neck, 42mm, 16° RV/AV, 130°, Purple NLS-421600P Table 7: Stem Lengths Stem Length Stem Size 4 5 6 7 8 9 10 11 12 Stem Length (mm) 110 115 120 130 136 142 148 155 160 15 Offset Appendix E Offset Chart and Acceptable Head/Neck Combination Tables Table 8: Monolithic (Offset with +0mm head) Neck Stem Size 4 5 6 127° NA NA 38mm 132° 31mm 32mm 34mm Top View Tables 9-12: Modular (Offset with +0mm head) Stem Size 0° Version 127° 132° 7 8 9 10 11 12 37.7mm 38.6mm 39.8mm 41.0mm 42.0mm 43.1mm 30mm Neck Length 8° Version 16° Version 132° 127° 130° 39.4mm 40.3mm 41.6mm 42.7mm 43.8mm 44.9mm 37.4mm 38.4mm 39.6mm 40.8mm 41.8mm 42.9mm 39.2mm 40.1mm 41.4mm 42.5mm 43.6mm 44.7mm Stem Size 7 8 9 10 11 12 37.6mm 38.6mm 39.8mm 41.0mm 42.0mm 43.1mm 38mm Neck Length 0° Version 8° Version 16° Version 132° 127° 127° 130° 132° Stem Size 7 8 9 10 11 12 43.6mm 44.5mm 45.7mm 46.9mm 48.0mm 49.0mm 45.8mm 46.7mm 48.0mm 49.1mm 50.2mm 51.3mm 43.3mm 44.2mm 45.5mm 46.6mm 47.7mm 48.8mm 45.5mm 46.5mm 47.7mm 48.8mm 49.9mm 51.0mm 7 8 9 10 11 12 43.6mm 44.5mm 45.7mm 46.9mm 48.0mm 49.0mm 46mm Total Head and Neck Length 0° Version 8° Version 16° Version 132° 127° 127° 130° 132° 49.5mm 50.5mm 51.7mm 52.9mm 53.9mm 55.0mm 52.2mm 53.2mm 54.4mm 55.6mm 55.6mm 57.7mm 49.2mm 50.1mm 51.4mm 52.5mm 53.6mm 54.7mm 51.9mm 52.8mm 54.0mm 55.2mm 56.2mm 57.3mm 40.4mm 41.3mm 42.5mm 43.7mm 44.7mm 45.8mm 42.3mm 43.3mm 44.5mm 45.7mm 46.7mm 47.8mm 40.6mm 41.6mm 42.8mm 43.9mm 45.0mm 46.1mm 42mm Neck Length 0° Version 8° Version 16° Version 132° 127° 127° 130° 132° 46.6mm 47.5mm 48.7mm 49.9mm 50.9mm 52.0mm 49.0mm 50.0mm 51.2mm 52.3mm 53.4mm 54.5mm 46.3mm 47.2mm 48.4mm 49.6mm 50.6mm 51.7mm 48.7mm 49.6mm 50.9mm 52.0mm 53.1mm 54.2mm N/A N/A 48.7mm 49.9mm 50.9mm 52.0mm Table 4: Max Total Head and Neck Construct Length per Version (Achieved only by combining a Modular Neck with a head offset greater than +0mm) 7 8 9 10 11 12 34mm Neck Length 8° Version 16° Version 132° 127° 130° 42.6mm 43.5mm 44.8mm 45.9mm 47.0mm 48.1mm 40.6mm 41.6mm 42.8mm 44.0mm 45.0mm 46.1mm Stem Size Table 13: Max Achievable Offset Stem Size 0° Version 127° 132° Stem Size Version 7 8 9 10 11 0° 46* 46* 46* 46* 46* 8° 46* 46* 46* 46* 46* 16° 38 38 42 46* 46* * Achieved only by combining a Modular Neck with a head offset greater than +0mm. N/A N/A N/A 52.9mm 53.9mm 55.0mm 12 46* 46* 46* Table 14: Head and Neck Combination* Modular Neck Implant -5mm † -4mm Femoral Head Offsets* -2.7mm -2.5mm +0mm +2.5mm +3mm +4mm +5mm +7.5mm +8mm +10mm +12mm 30mm ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔† ✔† 34mm ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔† ✔† ✔† ✔ †‡ ✔ †‡ 38mm ✔ ✔ ✔ ✔ ✔ ✔† ✔† ✔† ✔ †‡ ✔ †‡ ✔ †‡ 42mm ✔ ✔ ✔† ✔† ✔† ✔ †‡ ✔ †‡ ✔ †‡ 16° version not compatible with sizes 7 & 8 ‡ 16° version not compatible with size 9 * Not all offsets are available in all materials or all diameters. The table includes C-taper and V40 offset head options. Use of the C-taper head requires the assembly of a Titanium Adapter Sleeve (17-0000E) to convert the V40 stem trunnion to C-taper. See Appendix H for information on Component Compatibility for modular heads and acetabular components. Note Tables above may not be an exhaustive list of all femoral head options in all materials. 16 Appendix F Instrument Catalog Numbers Table 15: Rejuvenate Primary Instruments Rejuvenate Primary Instruments (continued) Cat. No. Description Cat. No. Description 1601-1600 Rejuvenate Stem Inserter 1601-2730 1601-1650* Rejuvenate Modular Stem Extractor Rejuvenate 30 mm, 8 Degree Neck Trial RV/AV 127/132 Degree Green 1601-1690 Rejuvenate Stem Impactor 1601-2734 1601-1700 Rejuvenate Head/Neck Impactor Rejuvenate 34 mm, 8 Degree Neck Trial RV/AV 127/132 Degree Green 1601-1801 Rejuvenate Neck Extractor 1601-2738 Rejuvenate 38 mm, 8 Degree Neck Trial RV/AV 127/132 Degree Green 1601-1100* Rejuvenate Broach Handle 1601-2742 1601-1900 Rejuvenate Adaptor Removal Tool Rejuvenate 42 mm, 8 Degree Neck Trial RV/AV 127/132 Degree Green 1440-1700 Offset Neck Trial Forceps 1601-2830 1101-2200 Orthonomic T-Handle Rejuvenate 30 mm, 16 Degree Neck Trial 130 Degree Purple 1020-2900 Orthonomic Modular Handle 1601-2834 1601-2526 Rejuvenate 26 mm, 0 Degree Neck Trial 127/132 Degree Black Rejuvenate 34 mm, 16 Degree Neck Trial 130 Degree Purple 1601-2838 1601-2530 Rejuvenate 30 mm, 0 Degree Neck Trial 127/132 Degree Black Rejuvenate 38 mm, 16 Degree Neck Trial 130 Degree Purple 1601-2842 1601-2534 Rejuvenate 34 mm, 0 Degree Neck Trial 127/132 Degree Black Rejuvenate 42 mm, 16 Degree Neck Trial 130 Degree Purple 1601-5010 Rejuvenate Neck Trial Caddy 26mm & 30mm 1601-2538 Rejuvenate 38 mm, 0 Degree Neck Trial 127/132 Degree Black 1601-5011 Rejuvenate Neck Trial Caddy 34mm 1601-5012 Rejuvenate Neck Trial Caddy 38mm 1601-2542 Rejuvenate 42 mm, 0 Degree Neck Trial 127/132 Degree Black 1601-5014 Rejuvenate Neck Trial Caddy 42mm 1601-2630 Rejuvenate 30 mm, 8 Degree Neck Trial AV/RV 127/132 Degree Yellow 1601-2634 Rejuvenate 34 mm, 8 Degree Neck Trial AV/RV 127/132 Degree Yellow Table 16: Trial Heads Cat. No. Description 6264-8-132R 32mm STD V40 Trial Head 36mm STD V40 Trial Head 1601-2638 Rejuvenate 38 mm, 8 Degree Neck Trial AV/RV 127/132 Degree Yellow 6264-8-136R 1601-2642 Rejuvenate 42 mm, 8 Degree Neck Trial AV/RV 127/132 Degree Yellow Note A total of 9 trial heads can be placed in the instrument tray. * Regular lubrication recommended. Refer to lubrication procedure, Literature LRJ-ISS. 17 Appendix F Instrument Catalog Numbers (continued) Table 17: Rejuvenate Femoral Preparation Instrumentation Table 18: Rejuvenate Instrument Cases Cat. No. Description Cat. No. Description 1601-1004A Rejuvenate Broach, Straight, size 4 1601-5000 Rejuvenate Instrument Case 1601-1005A Rejuvenate Broach, Straight, size 5 1601-5001 Rejuvenate Femoral Tray 1 1601-1006A Rejuvenate Broach, Straight, size 6 1601-5002 Rejuvenate Femoral Tray 2 1601-1007A Rejuvenate Broach, Straight, size 7 1601-5003 Rejuvenate Procedure Tray 1 1601-1008A Rejuvenate Broach, Straight, size 8 1601-5004 Rejuvenate Procedure Tray 2 1601-1009A Rejuvenate Broach, Straight, size 9 1601-1010A Rejuvenate Broach, Straight, size 10 1601-1011A Rejuvenate Broach, Straight, size 11 Cat. No. Description 1601-1012A Rejuvenate Broach, Straight, size 12 6260-4-090 McReynolds Distal Stem Adapter 1601-1210 Modular Box Osteotome 6869-1-000 Shaft, McReynolds Extractor Assembly 1601-1300 Rejuvenate Neck Resection Guide 6869-2-000 1601-1310 Ruler Driving Handle, McReynolds Extractor Assembly 1601-1400* Rejuvenate Calcar Planar, Standard 6869-3-000 1601-1420* Rejuvenate Calcar Planar, Large Sliding Hammer, McReynolds Extractor Assembly 1601-1504 Rejuvenate Starter Reamer 1601-1531 Rejuvenate Trochanteric Reamer, Standard 1601-1532 Rejuvenate Trochanteric Reamer, Large Cat. No. Description 1601-1556 Rejuvenate 2-for-1 Tapered Reamer, Size 5-6 1601-2000 Neck Trial Adapter (1 piece sterile) 1601-1578 Rejuvenate 2-for-1 Tapered reamer, Size 7-8 1601-1590 Rejuvenate 2-for-1 Tapered Reamer, Size 9-10 1601-1512 Rejuvenate 2-for-1 Tapered Reamer, Size 11-12 * Regular lubrication recommended. Refer to lubrication procedure, Literature LRJ-ISS. 18 Table 19: Ancillary Extraction Instruments Table 20: Miscellaneous Appendix G Neck Implant Decision Algorithm Sizes 7, 8, 9 Sizes 10, 11, 12 Choose Stem Angle Based on Patient Anatomy 127° or 132° Choose Stem Angle Based on Patient Anatomy 127° or 132° Choose Neutral (Black) Neck 34mm * Choose Neutral (Black) Neck 38mm * Std. +0mm trial head (Black) Std. +0mm trial head (Black) Trial Reduction Step #1 – Leg Length and Offset Assessment Trial Reduction Step #1 – Leg Length and Offset Assessment Increase or Decrease Neck Length Increase or Decrease Neck Length Increase or Decrease Head Offset – Fine Tuning Options depend on head diameter and material Increase or Decrease Head Offset – Fine Tuning Options depend on head diameter and material Trial Reduction Step #2 – Version Assessment Trial Reduction Step #2 – Version Assessment Flexion Impingement Use 8 Anteverted neck† † Extension Impingement Use 8 Retroverted neck† 16 version can also be used, but neck angle will change to 130° Flexion Impingement Use 8 Anteverted neck† † Extension Impingement Use 8 Retroverted neck† 16 version can also be used, but neck angle will change to 130° * Suggested starting point – final selection should be based on surgeon’s discretion. Total head and neck construct length should follow guidelines indicated in Appendix E. 19 Appendix H Component Compatibility Modular Heads Additional Information for Constrained Liners Table 21 includes a list of compatible Femoral Heads. See the package insert accompanying the specific component for the indications, contraindications, warnings, precautions and other information regarding the use of the Head. Maximum offset used may be restricted by Modular Stem body size and Modular Neck combinations. See Step 7 for Modular Stem-Modular Neck & Modular Head Guidelines for the appropriate combinations. Constrained Liners are intended for use in primary or revision patients at a high risk of hip dislocation due to a history of dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability. Table 21 Compatible Femoral Heads Offset V40 BIOLOX delta -5mm to +7.5mm V40 LFIT CoCr -5mm to +12mm C-Taper Alumina* -5mm to +5mm V40/C-taper Adapter Sleeve *Requires use of a Titanium V40 Adapter Sleeve (17-0000E) to convert the V40 stem trunnion to C-Taper. Compatible Acetabular Components The compatible Heads may be used with compatible Stryker unipolar, bipolar and acetabular components. Table 22 includes a list of compatible acetabular components. See the package insert accompanying the specific component for the indications, contraindications, warnings, precautions and other information regarding the use of the Head. See the individual surgical techniques for implantation of the acetabular components. Table 22 Compatible Acetabular Components Trident X3 Acetabular Inserts Trident Crossfire Elevated Rim Liners Trident Crossfire Polyethylene Liners, 10º or 0º profile Trident Crossfire Eccentric Poly Liners, 10º or 0º profile Trident Poly Liners, 10º or 0º profile Trident Eccentric Poly Liners Trident Constrained Insert Trident All Poly Cup Trident Crossfire All Poly Cup Unitrax Unipolar Head UHR Bipolar Head Trident N2/Vac Polyethylene Inserts Trident Hemispherical Shells Trident Hemispherical HA Shells Trident PSL HA Shells Trident Tritanium Shells Trident Alumina Insert used with a C-taper Alumina Head and a V40/C-taper Adapter Sleeve Restoration ADM Shells Tritanium PSF Shells Constrained Liners are contraindicated in patients with the following conditions: bone or musculature compromised by disease, infection or prior implantation, which cannot provide adequate support or fixation for the prosthesis, infection in or about the hip joint or skeletal immaturity. See the package insert accompanying the Constrained Liner for the indications, contraindications, warnings, precautions and other information regarding the use of the liner. See the surgical technique of the specific liner for the steps to appropriately implant the component. Compatible Ceramic Femoral Heads Table 23: V40 Taper BIOLOX delta Ceramic Heads Catalog Diameter Offset Trial No. (mm) (mm) Catalog No. 6570-0-028 28 -4 6264-8-028R 6570-0-328 28 -2.7 6264-8-928R 6570-0-128 28 +0 6264-8-128R 6570-0-228 28 +4 6264-8-228R 6570-0-032 32 -4 6264-8-032R 6570-0-132 32 +0 6264-8-132R 6570-0-232 32 +4 6264-8-232R 6570-0-036 36 -5 6264-8-036R 6570-0-436 36 -2.5 6264-8-436R 6570-0-136 36 +0 6264-8-136R 6570-0-536 36 +2.5 6264-8-536R 6570-0-236 36 +5 6264-8-236R 6570-0-736 36 +7.5 6264-8-736R Table 24: C-Taper BIOLOX delta Ceramic Heads Catalog Diameter Offset Trial No. (mm) (mm) Catalog No. 18-28-3 28 -2.5 1100-2897R 18-2800 28 +0 1100-2800R 18-2825 28 +2.5 1100-2825R 18-2805 28 +5 1100-2805R 18-32-3 32 -2.5 1100-3297R 18-3200 32 +0 1100-3200R 18-3225 32 +2.5 1100-3225R 18-3205 32 +5 1100-3205R 18-36-5 36 -5 1100-3699R 18-36-3 36 -2.5 1100-3697R 18-3600 36 +0 1100-3600R 18-3625 36 +2.5 1100-3625R 18-3605 36 +5 1100-3605R 18-3675 36 +7.5 1100-3675R Requires use of a Titanium V40 Adapter Sleeve (17-0000E) to convert the V40 stem trunnion to C-Taper Note Tables above may not be an exhaustive list of all options in all materials. Compatible Femoral Heads continued on next page. 20 Compatible Ceramic Femoral Heads (continued) Table 25: Universal Taper BIOLOX delta Ceramic Heads Catalog No. Diameter (mm) 6519-1-028 6519-1-032 6519-1-036 6519-1-040 6519-1-044 Requires use of Universal Adapter Sleeve. 28 32 36 40 44 Table 26: Universal Trial Heads Catalog Diameter Offset No. (mm) (mm) 6264-8-728R 6264-8-632R 6264-3-236R 6264-8-940R 6264-8-944R 28 32 36 40 44 -2.5 -2.5 +4.0 -2.5 -2.5 Taper V40 V40 V40 V40 V40 Table 28: C-Taper Alumina Ceramic Heads Catalog Diameter Offset Trial (mm) (mm) Catalog No. No. 17-28-3E 28 –2.5 1100-2897R 17-2800E 28 +0 1100-2800R 17-2805E 28 +5 1100-2805R 17-32-3E 32 –2.5 1100-3297R 17-3200E 32 +0 1100-3200R 17-3205E 32 +5 1100-3205R 17-36-5E 36 –5 1100-3699R 17-3600E 36 +0 1100-3600R 17-3605E 36 +5 1100-3605R Requires use of a Titanium V40 Adapter Sleeve (17-0000E) to convert the V40 stem trunnion to C-Taper Table 27: Universal Adapter Sleeves - Titanium Catalog No. Offset (mm) Taper 6519-T-025 6519-T-100 6519-T-204 -2.5 +0 +4 V40 V40 V40 Compatible CoCr Femoral Heads Table 29: V40 Taper LFIT Heads Catalog Diameter Offset No. (mm) (mm) 6260-9-122 22 +0 6260-9-222 22 +3 6260-9-322 22 +8 6260-9-026 26 -3 6260-9-126 26 +0 6260-9-226 26 +4 6260-9-326 26 +8 6260-9-426 26 +12 6260-9-028 28 -4 6260-9-128 28 +0 6260-9-228 28 +4 6260-9-328 28 +8 6260-9-428 28 +12 6260-9-032 32 -4 6260-9-132 32 +0 6260-9-232 32 +4 6260-9-332 32 +8 6260-9-432 32 +12 Trial Catalog No. 6264-8-122R 6264-8-222R 6264-8-322R 6264-8-026R 6264-8-126R 6264-7-226R 6264-8-326R 6264-8-426R 6264-8-028R 6264-8-128R 6264-8-228R 6264-8-328R 6264-8-428R 6264-8-032R 6264-8-132R 6264-8-232R 6264-8-332R 6264-8-432R Table 30: V40 Taper LFIT Anatomic Heads Catalog Diameter Offset Trial No. (mm) (mm) Catalog No. 6260-9-036 36 -5 6264-8-036R 6260-9-136 36 +0 6264-8-136R 6260-9-236 36 +5 6264-8-236R 6260-9-336 36 +10 6264-8-336R 6260-9-040 40 -4 6264-8-040R 6260-9-140 40 +0 6264-8-140R 6260-9-240 40 +4 6264-8-240R 6260-9-340 40 +8 6264-8-340R 6260-9-440 40 +12 6264-8-440R 6260-9-044 44 -4 6264-8-044R 6260-9-144 44 +0 6264-8-144R 6260-9-244 44 +4 6264-8-244R Note Tables above may not be an exhaustive list of all options in all materials. 21 References 1. Steppacher, S.D., Ecker, T.M., et al. Managing Length and Stability: The role of the modular neck. Orthopaedics, Vol.31, No.9, September 2008. 2. RD-07-027 Fatigue Performance of the Rejuvenate Modular Stem/neck construct under a modified ISO neck test model. 3. Capello, W., et al. Hydroxyapatite-coated Femoral Components, 15-Year Minimum Followup, CORR, Vol.453, December 2006:pp.75 - 80. 325 Corporate Drive Mahwah, NJ 07430 t: 201 831 5000 www.stryker.com A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery. The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any Stryker product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area. Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: Accolade, Crossfire, LFIT, N2/Vac, OmniFit, PSL, PureFix, Rejuvenate, Restoration, Secur-Fit, Stryker, TMZF, Trident, Tritanium, UHR, Unitrax, V40, X3. All other trademarks are trademarks of their respective owners or holders. Literature Number: LSP65 Rev.3 MS/GS 07/11 Copyright © 2011 Stryker Printed in USA.
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