Rejuvenate Total Hip System Surgical Protocol. Rejuvenate Modular Hip Stem Enhanced Stability 1 Proven Modularity 2 Intraoperative Flexibility

Transcription

1 Rejuvenate Total Hip System Surgical Protocol Rejuvenate Modular Hip Stem Enhanced Stability 1 Proven Modularity 2 Intraoperative Flexibility

2 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 2 Preparing The Femoral Canal Step 3 Broaching the Femur... 5 Step 4 Calcar Planing... 6 Step 5 Trial Reduction Off Broach... 6 Monolithic Stem Option... 6 Modular Stem Option... 7 Step 6 Stem Implantation... 8 Step 7 Trial Reduction Off Stem... 9 Modular Stem Option Only Step 8 Neck and Head Implantation Appendix A Options: Modular Neck Extraction Appendix B Options: Stem Extraction Appendix C Modular Instrument Component Diagram Appendix D Implant Catalog Numbers and Stem Lengths Appendix E Offset Chart and Acceptable Head/Neck Combination Tables Appendix F Instrument Catalog Numbers Appendix G Neck Implant Decision Algorithm Appendix H Component Compatibility Surgeon Contributors: William N. Capello, M.D. Indiana University School of Medicine Indianapolis, IN James P. Crutcher, M.D. Swedish Medical Center Seattle, WA 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 Joseph J. Jankiewicz, M.D. Sharps-Reely Hospital San Diego, CA James Kudrna, M.D., PhD University of Chicago Pritzker School of Medicine Chicago, IL 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 Lawrence G. Morawa, M.D. Oakwood Hospital Dearborn, MI Joseph P. Nessler, M.D. St. Cloud Hospital St. Cloud, MN 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.

3 Preoperative Templating The Rejuvenate Femoral Platform includes a complete set of both acetate (120% magnification) and digital femoral templates. Acetabular Options 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. Surgical Approaches 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. 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 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. Conditions presenting increased risk of failure include: 1)uncooperative patient or patient with neurologic disorders, incapable of following instructions; 2) osteoporosis; 3) metabolic disorders which may impair bone formation; and, 4) osteomalacia. Patients should be warned of these contraindications and risks. See the package insert for warnings, precautions, adverse effects and other essential product information. 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. 1

4 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 Center of Rotation 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. 1 Trochanteric Fossa Proximal Femoral Axis 2 Scale on Resection Guide corresponds to scale on the templates Identifying the Proximal Femoral Shaft Axis 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). 39 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. 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

5 2 Preparing The Femoral Canal 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. 3 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 Medial Resection Point 3

6 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. Option For Sizes 4-6, the standard Trochanteric Reamer is optional and to be used according to surgeon s discretion. Medial Resection Point Table 1: Recommended Trochanteric Reamer Sizes Stem Size Tapered Reamer 7-9 Standard Trochanteric Reamer Large Trochanteric Reamer Broach Only Option 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. 6 Size 7 Size 8 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). 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. Caution Reamers are sharp and aggressive. Table 2: Recommended Tapered Reamer Sizes Stem Size Tapered Reamer For size 4, Starter Reamer acts as Tapered Reamer. Tip If preoperative templating results in an in-between size, ream to smaller size. 4

7 3 Broaching The Femur 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. 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. Tip 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. 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 Quick Release Button Locking Hook Broach Locking Arm Alignment Tab 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. Regular lubrication of Broach Handle is recommended mm press-fit per side Press-fit gradient to end of Plasma Spray region Line to line 5

8 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 Calcar Planer removes less than 4mm of bone. Bone remnants can be removed from the Calcar Planer to continue calcar planing. Regular lubrication of Calcar Planers is recommended. Caution Failure to operate the Calcar Planer in accordance with the instructions above may result in damage to the femur. 11 Neck Trial Trial Reduction Off Broach Monolithic Stem Option 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 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. 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). Direction Color Coding Version Degrees If neck angle direction arrow points superiorly #, neck angle is 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 Stem Size Neck Length 26mm 26mm 26mm 30mm Face of Neck Trial Maximum Femoral Head Offset +8mm +12mm +12mm +12mm Max Head and Neck Combined Length 34mm 38mm 38mm 42mm Size 6 is the only monolithic stem available with 127 neck angle. 6

9 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: On the end of the trunnion: Version degrees Arrow indicating version and neck angle direction Color coding dot indicating version On the inferior and superior surfaces: The neck angle marking facing superiorly represents the angle in use Neck length 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. 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. Table 4: Max Total Head and Neck Construct Length per Version Stem Size Version * 46* 46* 46* 46* 46* 8 46* 46* 46* 46* 46* 46* * 46* 46* * Achieved only by combining a Modular Neck with a head offset greater than +0mm. 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. 12 Neck Trial Direction Version Direction Color Coding Version Degrees Face of Neck Trial If neck angle direction arrow points superiorly #, neck angle is 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 Total Head & Neck Construct Length Neck Length Head = Offset + Head Offset Modular Neck 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

10 6 Stem Implantation The Rejuvenate Femoral Platform offers two instrument options to insert the monolithic and modular stems (Figure 13): 13a Option 1: Stem Inserter Option 2: Stem Impactor 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). 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). 30 Max Stem Impactor Do not exceed a greater than 30 impacting angle from the axis of the stem 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 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). Resection Level 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 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. Caution 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. 8

11 7 Trial Reduction Off Stem 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 On the inferior and superior surfaces: The neck angle marking facing superiorly represents the angle in use Neck length 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 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. Table 4: Max Total Head and Neck Construct Length per Version Stem Size Version * 46* 46* 46* 46* 46* 8 46* 46* 46* 46* 46* 46* * 46* 46* * Achieved only by combining a Modular Neck with a head offset greater than +0mm. 14 Direction Version Direction Color Coding 127 Version Degrees If neck angle direction arrow points superiorly #, neck angle is 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 Neck Trial Adapter Neck Length Neck Trial Modular Stem Face of Neck Trial 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 & Neck Construct Length Head = Offset + Modular Neck Length 9

12 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). 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. The example at right demonstrates the labeling convention for a 38mm Modular Neck with 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. 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. 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 ). 15 Neck Trial Direction Version Direction 8 Version Green Dot Face of Neck Implant V40 38mm 8 G Catalog No. NLV G Neck Trial Caddy Neck Implant Trunnion Taper Neck Length G -Green Caution Do not apply torsional force to Adaptor during removal Neck Trial Adapter Removal Tool 10

13 Illustration of Neck Trial and Neck Implant for Right / Left Hip Right Hip Left Hip Right Hip 8 Anteversion Trial Implant Left Hip Anteversion Trial Implant Anteverted Anteverted 8 Face of Neck Trial V40 30mm 8 G Face of Neck Implant 8 Face of Neck Trial V40 30mm 8 G Face of Neck Implant Right Hip Retroversion Trial Implant Left Hip 8 Retroversion Trial Implant Retroverted Retroverted 8 Face of Neck Trial V40 30mm 8 G Face of Neck Implant 8 Face of Neck Trial V40 30mm 8 G Face of Neck Implant Four boxes above demonstrate how the Neck Trial and the Neck Implant can be used in the right and left hip. Neck Trial Option Chart Neck Trial Caddy 16 Retro Purple 16 Retro Purple Retro Green 8 Retro Yellow Retro Yellow 8 Retro Green Neutral Black 0 Neutral Black Neutral Black 0 Neutral Black Ante Yellow 8 Ante Green Ante Green 8 Ante Yellow Right Hip 16 Ante Purple Left Hip 16 Ante Purple 11

14 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. 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.* 17 Neck and Head Impactor Modular Handle 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. 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 ( E) and a C-Taper ceramic Head or a V40 Universal Adapter Sleeve and a BIOLOX delta Universal Taper ceramic Head. If Universal Head is selected, impact Modular Neck to Stem before placing Universal Adapter Sleeve on Neck. Alumina ceramic femoral Heads cannot be used directly on the Cobalt Chrome Modular Neck and require the use of a Titanium V40 Adapter Sleeve ( E) to convert the V40 stem trunnion to C-Taper. A fully seated neck implant in the Modular Stem 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 Stem Material Part Numbers Taper Compatibility 19-0XXXT C-Taper TMZF, Ti-6Al-4V, CoCr 6519-T-XXX V40 TMZF, Ti-6Al-4V, CoCr After completing the trialing process, intra operatively 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 ( ). Care must be taken to avoid excessive impact forces when assembling the Ceramic Head to the sleeved femoral component. 12

15 APPENDICES Table of Contents Appendix A Options: Modular Neck Extraction Appendix B Options: Stem Extraction Appendix C Modular Instrument Component Diagram Appendix D Implant Catalog Numbers and Stem Lengths Appendix E Offset Chart and Acceptable Head/Neck Combination Tables...16 Appendix F Instrument Catalog Numbers Appendix G Neck Implant Decision Algorithm Appendix H Component Compatibility

16 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 ( , , ) 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 ( ) and McReynolds Driver ( , , ) from the Restoration Modular Instrument System. Neck Trial Forceps Neck Implant Neck Extractor Caution Do NOT impact the Locking Knob of the Modular Stem Extractor as this could damage it. The Stem Inserter should not be used to extract the Stem. 19 Modular Stem Extraction Monolithic Stem Extraction Appendix C Modular Instrument Component Diagram 20 McReynolds Extractor Assembly Box Osteotome Modular Handle Stem Impactor Locking Knob McReynolds Distal Stem Adapter Head/Neck Impactor Extractor Locking Arm Extractor Connection Tip Ensure instrument is fully seated in the Modular Handle before use. 14

17 Appendix D Implant Catalog Numbers and Stem Lengths Table 6: Monolithic Stem, Modular Stem and Modular Neck Implants Monolithic Stems Rejuvenate Straight Press-fit Texture TMZF Monolithic Stem, Size 4, Rejuvenate Straight Press-fit Texture TMZF Monolithic Stem, Size 5, Rejuvenate Straight Press-fit Texture TMZF Monolithic Stem, Size 6, Rejuvenate Straight Press-fit Texture TMZF Monolithic Stem, Size 6, 127 Modular Stems Rejuvenate Straight Press-fit Texture TMZF Modular Stem, Size 7 Rejuvenate Straight Press-fit Texture TMZF Modular Stem, Size 8 Rejuvenate Straight Press-fit Texture TMZF Modular Stem, Size 9 Rejuvenate Straight Press-fit Texture TMZF Modular Stem, Size 10 Rejuvenate Straight Press-fit Texture TMZF Modular Stem, Size 11 Rejuvenate Straight Press-fit Texture TMZF Modular Stem, Size 12 Modular Necks Rejuvenate Modular Neck, 30mm, 0, 127 /, Black Rejuvenate Modular Neck, 30mm, 8 AV/RV, 127 /, Yellow Rejuvenate Modular Neck, 30mm, 8 RV/AV, 127 /, Green Rejuvenate Modular Neck, 30mm, 16 RV/AV, 130, Purple Rejuvenate Modular Neck, 34mm, 0, 127 /, Black Rejuvenate Modular Neck, 34mm, 8 AV/RV, 127 /, Yellow Rejuvenate Modular Neck, 34mm, 8 RV/AV, 127 /, Green Rejuvenate Modular Neck, 34mm, 16 RV/AV, 130, Purple Rejuvenate Modular Neck, 38mm, 0, 127 /, Black Rejuvenate Modular Neck, 38mm, 8 AV/RV, 127 /, Yellow Rejuvenate Modular Neck, 38mm, 8 RV/AV, 127 /, Green Rejuvenate Modular Neck, 38mm, 16 RV/AV, 130, Purple Rejuvenate Modular Neck, 42mm, 0, 127 /, Black Rejuvenate Modular Neck, 42mm, 8 AV/RV, 127 /, Yellow Rejuvenate Modular Neck, 42mm, 8 RV/AV, 127 /, Green Rejuvenate Modular Neck, 42mm, 16 RV/AV, 130, Purple Cat. No. SPT S SPT S SPT S SPT S Cat. No. SPT S SPT S SPT S SPT S SPT S SPT S Cat. No. NLS B NLV Y NLV G NLS P NLS B NLV Y NLV G NLS P NLS B NLV Y NLV G NLS P NLS B NLV Y NLV G NLS P Stem Length Table 7: Stem Lengths Stem Size Stem Length (mm)

18 Offset Appendix E Offset Chart and Acceptable Head/Neck Combination Tables Table 8: Monolithic (Offset with +0mm head) Stem Neck Size mm 32mm 34mm 127 NA NA 38mm Tables 9-12: Modular (Offset with +0mm head) 30mm Neck Length Stem Size 0 Version 8 Version 16 Version mm 39.4mm 37.4mm 39.2mm 38.6mm 40.3mm 38.4mm 40.1mm 39.8mm 41.6mm 39.6mm 41.4mm 41.0mm 42.7mm 40.8mm 42.5mm 42.0mm 43.8mm 41.8mm 43.6mm 43.1mm 44.9mm 42.9mm 44.7mm 37.6mm 38.6mm 39.8mm 41.0mm 42.0mm 43.1mm Stem Size mm Neck Length 0 Version 8 Version 16 Version mm 45.8mm 43.3mm 45.5mm 43.6mm 44.5mm 46.7mm 44.2mm 46.5mm 44.5mm 45.7mm 48.0mm 45.5mm 47.7mm 45.7mm 46.9mm 49.1mm 46.6mm 48.8mm 46.9mm 48.0mm 50.2mm 47.7mm 49.9mm 48.0mm 49.0mm 51.3mm 48.8mm 51.0mm 49.0mm Stem Size Stem Size Top View 34mm Neck Length 0 Version 8 Version 16 Version mm 42.6mm 40.4mm 42.3mm 40.6mm 41.6mm 43.5mm 41.3mm 43.3mm 41.6mm 42.8mm 44.8mm 42.5mm 44.5mm 42.8mm 44.0mm 45.9mm 43.7mm 45.7mm 43.9mm 45.0mm 47.0mm 44.7mm 46.7mm 45.0mm 46.1mm 48.1mm 45.8mm 47.8mm 46.1mm 42mm Neck Length 0 Version 8 Version 16 Version mm 49.0mm 46.3mm 48.7mm N/A 47.5mm 50.0mm 47.2mm 49.6mm N/A 48.7mm 51.2mm 48.4mm 50.9mm 48.7mm 49.9mm 52.3mm 49.6mm 52.0mm 49.9mm 50.9mm 53.4mm 50.6mm 53.1mm 50.9mm 52.0mm 54.5mm 51.7mm 54.2mm 52.0mm Table 13: Max Achievable Offset (Achieved only by combining a Modular Neck with a head offset greater than +0mm) Stem Size mm Total Head and Neck Length 0 Version 8 Version 16 Version mm 52.2mm 49.2mm 51.9mm 50.5mm 53.2mm 50.1mm 52.8mm 51.7mm 54.4mm 51.4mm 54.0mm 52.9mm 55.6mm 52.5mm 55.2mm 53.9mm 55.6mm 53.6mm 56.2mm 55.0mm 57.7mm 54.7mm 57.3mm N/A N/A N/A 52.9mm 53.9mm 55.0mm Table 4: Max Total Head and Neck Construct Length per Version Stem Size Version * 46* 46* 46* 46* 46* 8 46* 46* 46* 46* 46* 46* * 46* 46* * Achieved only by combining a Modular Neck with a head offset greater than +0mm. Table 14: Head and Neck Combination* Modular Neck Implant -5mm -4mm -2.7mm -2.5mm +0mm Femoral Head Offsets* +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 ( E) to convert the V40 stem trunnion to C-taper. See Appendix H for information on Component Compatibility for modular heads and acetabular components. Tables above may not be an exhaustive list of all femoral head options in all materials. 16

19 Appendix F Instrument Catalog Numbers Table 15: Rejuvenate Primary Instruments Cat. No. Description Rejuvenate Stem Inserter * Rejuvenate Modular Stem Extractor Rejuvenate Stem Impactor Rejuvenate Head/Neck Impactor Rejuvenate Neck Extractor * Rejuvenate Broach Handle Rejuvenate Adaptor Removal Tool Offset Neck Trial Forceps Orthonomic T-Handle Orthonomic Modular Handle Rejuvenate 26 mm, 0 Degree Neck Trial 127/132 Degree Black Rejuvenate 30 mm, 0 Degree Neck Trial 127/132 Degree Black Rejuvenate 34 mm, 0 Degree Neck Trial 127/132 Degree Black Rejuvenate 38 mm, 0 Degree Neck Trial 127/132 Degree Black Rejuvenate 42 mm, 0 Degree Neck Trial 127/132 Degree Black Rejuvenate 30 mm, 8 Degree Neck Trial AV/RV 127/132 Degree Yellow Rejuvenate 34 mm, 8 Degree Neck Trial AV/RV 127/132 Degree Yellow Rejuvenate 38 mm, 8 Degree Neck Trial AV/RV 127/132 Degree Yellow Rejuvenate 42 mm, 8 Degree Neck Trial AV/RV 127/132 Degree Yellow * Regular lubrication recommended. Refer to lubrication procedure, Literature LRJ-ISS. Rejuvenate Primary Instruments (continued) Cat. No. Description Rejuvenate 30 mm, 8 Degree Neck Trial RV/AV 127/132 Degree Green Rejuvenate 34 mm, 8 Degree Neck Trial RV/AV 127/132 Degree Green Rejuvenate 38 mm, 8 Degree Neck Trial RV/AV 127/132 Degree Green Rejuvenate 42 mm, 8 Degree Neck Trial RV/AV 127/132 Degree Green Rejuvenate 30 mm, 16 Degree Neck Trial 130 Degree Purple Rejuvenate 34 mm, 16 Degree Neck Trial 130 Degree Purple Rejuvenate 38 mm, 16 Degree Neck Trial 130 Degree Purple Rejuvenate 42 mm, 16 Degree Neck Trial 130 Degree Purple Rejuvenate Neck Trial Caddy 26mm & 30mm Rejuvenate Neck Trial Caddy 34mm Rejuvenate Neck Trial Caddy 38mm Rejuvenate Neck Trial Caddy 42mm Table 16: Trial Heads Cat. No R R Description 32mm STD V40 Trial Head 36mm STD V40 Trial Head A total of 9 trial heads can be placed in the instrument tray. 17

20 Appendix F Instrument Catalog Numbers (continued) Table 17: Rejuvenate Femoral Preparation Instrumentation Cat. No. Description A Rejuvenate Broach, Straight, size A Rejuvenate Broach, Straight, size A Rejuvenate Broach, Straight, size A Rejuvenate Broach, Straight, size A Rejuvenate Broach, Straight, size A Rejuvenate Broach, Straight, size A Rejuvenate Broach, Straight, size A Rejuvenate Broach, Straight, size A Rejuvenate Broach, Straight, size Modular Box Osteotome Rejuvenate Neck Resection Guide Ruler * Rejuvenate Calcar Planar, Standard * Rejuvenate Calcar Planar, Large Rejuvenate Starter Reamer Rejuvenate Trochanteric Reamer, Standard Rejuvenate Trochanteric Reamer, Large Rejuvenate 2-for-1 Tapered Reamer, Size Rejuvenate 2-for-1 Tapered reamer, Size Rejuvenate 2-for-1 Tapered Reamer, Size Rejuvenate 2-for-1 Tapered Reamer, Size Table 18: Rejuvenate Instrument Cases Cat. No. Description Rejuvenate Instrument Case Rejuvenate Femoral Tray Rejuvenate Femoral Tray Rejuvenate Procedure Tray Rejuvenate Procedure Tray 2 Table 19: Ancillary Extraction Instruments Cat. No. Description McReynolds Distal Stem Adapter Shaft, McReynolds Extractor Assembly Driving Handle, McReynolds Extractor Assembly Sliding Hammer, McReynolds Extractor Assembly Table 20: Miscellaneous Cat. No. Description Neck Trial Adapter (1 piece sterile) * Regular lubrication recommended. Refer to lubrication procedure, Literature LRJ-ISS. 18

21 Appendix G Neck Implant Decision Algorithm Sizes 7, 8, 9 Sizes 10, 11, 12 Choose Stem Angle Based on Patient Anatomy 127 or Choose Neutral (Black) Neck 34mm* Choose Stem Angle Based on Patient Anatomy 127 or 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 Flexion Impingement Use 8 Anteverted neck Extension Impingement Use 8 Retroverted neck 16 version can also be used, but neck angle will change to 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

22 Appendix H Component Compatibility Modular Heads 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. 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 ( E) 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 Additional Information for Constrained Liners 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. 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 R R R R R R R R R R R R R Table 24: C-Taper BIOLOX delta Ceramic Heads Catalog Diameter Offset Trial No. (mm) (mm) Catalog No R R R R R R R R R R R R R R Requires use of a Titanium V40 Adapter Sleeve ( E) to convert the V40 stem trunnion to C-Taper Tables above may not be an exhaustive list of all options in all materials. Compatible Femoral Heads continued on next page. 20

23 Compatible Ceramic Femoral Heads (continued) Table 25: Universal Taper BIOLOX delta Ceramic Heads Catalog No. Diameter (mm) Requires use of Universal Adapter Sleeve. Table 26: Universal Trial Heads Catalog Diameter Offset No. (mm) (mm) Taper R V R V R V R V R V40 Table 28: C-Taper Alumina Ceramic Heads Catalog Diameter Offset Trial No. (mm) (mm) Catalog No E R E R E R E R E R E R E R E R E R Requires use of a Titanium V40 Adapter Sleeve ( E) to convert the V40 stem trunnion to C-Taper Table 27: Universal Adapter Sleeves - Titanium Catalog No. Offset (mm) Taper 6519-T V T V T V40 Compatible CoCr Femoral Heads Table 29: V40 Taper LFIT Heads Catalog Diameter Offset Trial No. (mm) (mm) Catalog No R R R R R R R R R R R R R R R R R R Table 30: V40 Taper LFIT Anatomic Heads Catalog Diameter Offset Trial No. (mm) (mm) Catalog No R R R R R R R R R R R R Tables above may not be an exhaustive list of all options in all materials. 21