STATURE. Never Compromise. Modular Hip Reconstruction PRODUCT CATALOG. Your stem philosophy. Your neck choice. Your cup preference.

Transcription

1 STATURE Modular Hip Reconstruction PRODUCT CATALOG Your stem philosophy. Your neck choice. Your cup preference. Never Compromise.

2 STATURE Modular Hip Reconstruction Superior Product PROFEMUR Modular Necks»» Seat stem in best possible bone stock»» Control leg length, offset, and version Multiple Stem Options»» PROFEMUR Plasma Z Stem»» PROFEMUR Z Stem»» PROFEMUR T Stem»» PROFEMUR RENAISSANCE Stem»» PROFEMUR R Stem»» PROFEMUR RAZ Stem»» PROFEMUR LX Stem»» PROFEMUR X m Stem»» PROFEMUR TL Stem Ease of Use Multiple Broach-Only Techniques»» PROFEMUR Plasma Z Stem»» PROFEMUR Z Stem»» PROFEMUR TL Stem»» PROFEMUR RAZ Stem»» PROFEMUR X m Stem Modular Neck Technology»» Intraoperative flexibility Tissue-Preserving Implants»» Streamlined implants for tissue sparing insertion Modular Necks - Optimal Restoration of Normal Hip Biomechanics»» Leg length»» Varus, Valgus»» Anteversion, Retroversion STATURE Modular Hip Reconstruction

3 PROFEMUR Modular Necks a STATURE product 4 / 8 / 5 Anteversion or Retroversion Technology You Can Trust»» Over 50,000 modular necks sold worldwide since 985. And Use»» Avoid impingement Improved ROM results in decreased dislocation»» Independently adjust leg length and offset»» Correct minor variations in cup position without changing stem version»» Minimize incision and soft tissue trauma 6 / 8 / 5 Varus or Valgus. Data on file at Wright. Utilize PROFEMUR Modular Necks with Wright s DYNASTY Acetabular Cup System and ConservE Total Hip System. PROFEMUR Modular Necks

4 PROFEMUR Z / Plasma Z Stems a STATURE product Abbreviated Technique: Broach-only Sequentially broach for optimal fit Implant size corresponding to broach size Driving Platform Dimpled driving platform for stem insertion Ordering Information: Templates PRFZ-XR5 Surgical Technique MH Instruments 425-KIT PRZS-KIT2 (In-line Broaches) Implants 425-KITA (Z) 425-KITB (Plasma Z) 325-KITN (Mod. Necks) Rectangular Cross-Section Provides rotational stability and conserves bone for increased vascularization Trochanteric Wing Increased trochanteric wing contributes to proximal fill and rotational stability Dual Taper Geometry Provides optimal primary fixation and load transfer Plasma Z Plasma Spray Provides additional.5mm press-fit (.25mm per side) for initial stability and longterm ingrowth Surface Roughness Heavy grit blast texture (6Ra µm) of titanium stem promotes bone ongrowth and implant stability Surface Roughness Heavy grit blast texture (6Ra µm) of titanium stem promotes bone ongrowth and implant stability Sizes Available in sizes -9 Rounded Distal Tip Reduces the potential for thigh pain Rounded Distal Tip Reduces the potential for thigh pain PROFEMUR Z / Plasma Z Stems

5 PROFEMUR T Stem a STATURE product Proximal Loading Stem:»» Maintains physiologic stress on the proximal femur»» Reduces stress shielding»» Provides axial and rotational stability»» Self-stabilizing geometry Driving Platform Threaded driving platform for rotational and axial implant control during insertion Lateral Shoulder Rounded lateral shoulder eases stem insertion and minimizes risk of fracture Abbreviated Technique: Ream and Broach Ream to templated size or cortical chatter Broach to corresponding reamer size Implant size corresponding to broach size Proximal Taper 3 proximal anterior/lateral/posterior taper improves proximal fill Plasma Spray Provides additional.5mm pressfit (.25mm per side) for initial stability and long-term ingrowth Ordering Information: Templates PRFT-XR5 Surgical Technique MH Instruments PRGI-KIT (General) PRTB-KIT (Reamers/Broaches) PTSB-KIT (Slotted Reamers/ Broaches) Implants 625-KITI (Stems) 325-KITN (Modular Necks) Surface Roughness Heavy grit blast texture (5Ra µm) of titanium stem promotes bone ongrowth and implant stability Anti-Rotation Splines Provides additional.5mm press-fit (.75mm per side) for rotational and torsional stability. Sizes Available in Sizes 9-8 Narrow Distal Taper Bullet-shaped, polished tip reduces potential for thigh pain and minimizes reaming PROFEMUR T Stem

6 PROFEMUR Renaissance Stem a STATURE product Abbreviated Technique: Ream and Broach Ream to templated size Sequentially broach with reduced flare broaches to corresponding reamer size If fit is not secure, switch to standard flare broach or ream and broach to larger stem size Implant size and flare corresponding to broach size and flare Ordering Information: Templates PLS0-XR5 Surgical Technique MH Instruments PRGI-KIT (General) PLRE-KIT (Reamers) PLBR-KIT (Broaches) Implants PLIM-KITA (Stems) 325-KITN (Modular Necks) Proximal Taper 3 proximal anterior/ lateral/posterior taper improves proximal fill Flare Standard and Reduced flare options ensure metaphyseal fit Driving Platform Threaded driving platform for rotational and axial implant control during insertion Lateral Shoulder Rounded lateral shoulder eases stem insertion and minimizes risk of fracture Surface Roughness Light grit blast texture of titanium stem promotes bone ongrowth and implant stability Distal Splines Provide additional mm press-fit (.5mm per side) for rotational stability Distal Slot Reduces potential for thigh pain and risk of fracture during stem insertion Sizes Available in Reduced Flare, Sizes 0-6 and Standard Flare, Sizes 0-8 CaSO4-coated PROFEMUR RENAISSANCE Stem also available Distal Bullet Tip Round distal tip reduces stress between implant and bone, decreasing potential for thigh pain and risk of fracture during stem insertion PROFEMUR Renaissance Stem

7 PROFEMUR RAZ Stem a STATURE product Abbreviated Technique: Broach-only Sequentially broach for optimal fit Implant size corresponding to broach size Driving Platform Threaded driving platform for rotational and axial implant control during insertion Ordering Information: Templates PYRD-XR5 Surgical Technique MH Instruments PRGI-KIT (General) PYRD-KIT (Broaches) Implants PYRD-KITA (Stems) 325-KITN (Mod. Necks) Rectangular Cross-Section Provides rotational stability and conserves bone for increased vascularization Dual Taper Geometry Provides optimal primary fixation and load transfer Trochanteric Wing Increased trochanteric wing contributes to proximal fill and rotational stability Surface Roughness Heavy grit blast texture (6Ra mm) of titanium stem promotes bone ongrowth and implant stability Lateral View Sizes Available in Sizes -9 Proximal A/P Surface Increased material contributes to proximal fill and rotational stability Rounded Distal Tip Reduces the potential for thigh pain PROFEMUR RAZ Stem

8 PROFEMUR TL Stem a STATURE product Abbreviated Technique: Broach-only Sequentially broach for optimal fit Implant size corresponding to broach size Driving Platform Dimpled driving platform for stem insertion Ordering Information: Templates PRTL-XR5 Surgical Technique MH Instruments PRGI-KIT (General) PRTL-KIT2 (Broaches) Implants PRTL-KITA (Stems) 325-KITN (Mod. Necks) Lateral Shoulder Reduced material helps to conserve bone and ease insertion Plasma Spray Provides additional.5mm pressfit (.25mm per side) for initial stability and long-term ingrowth Flat Tapered Wedge Geometry Provides firm mediolateral stability within the femoral canal Slim A/P Dimension Conserves bone while providing excellent torsional stability Surface Roughness Light grit blast texture of titanium stem promotes bone ongrowth and implant stability Sizes Available in Sizes -2 PROFEMUR TL Stem

9 PROFEMUR LX Stem a STATURE product Abbreviated Technique: Ream and Broach Ream to templated size or cortical chatter Broach to corresponding reamer size Implant size corresponding to broach size Driving Platform Threaded driving platform for rotational and axial implant control during insertion Ordering Information: Templates PLX0-XR5 Surgical Technique MH Instruments PRGI-KIT (General) PRLX-KIT (Broaches) PRLX-KIT2 (Reamers) Implants PRLX-KITA (Stems) 325-KITN (Mod. Necks) Plasma Spray Provides additional.5mm press-fit (.25mm per side) for initial stability and long-term ongrowth Surface Roughness Heavy grit blast texture (8Ra µm) of titanium stem promotes bone ongrowth and implant stability Lateral View Sizes Available in Sizes -9 Lateral Shoulder Rounded lateral shoulder eases stem insertion and minimizes risk of fracture Proximal Taper 3 proximal anterior/ lateral/posterior taper improves proximal fill Distal Splines Provide additional 0.25mm press-fit for rotational stability Distal Slot Reduces potential for thigh pain and risk of fracture during stem insertion Distal Bullet Tip Round distal tip reduces stress between implant and bone, decreasing potential for thigh pain and risk of fracture during stem insertion PROFEMUR LX Stem

10 PROFEMUR X m Stem a STATURE product Abbreviated Technique: Broach-only Sequentially broach for optimal fit Implant size corresponding to broach size (Broach prepares for 2mm circumferential cement mantle) Ordering Information: Templates PRXM-XR5 Surgical Technique MH Instruments PXTR-KIT (Broaches) 425-KIT (General) Implants PHA (Sz. 0) PHA (Sz. ) PHA (Sz. 2) PHA (Sz. 3) PHA (Sz. 4) 325-KITN (Mod. Necks) Dual Taper Geometry Promotes cement engagement and provides rotational stability Surface Highly polished, forged CoCr stem reduces friction at the cement-implant interface, reducing the potential for wear Rounded Edges Promotes radial compressive loading Sizes Available in sizes 0-4 Distal Centralizers Allow distal stem engagement within the cement mantle PROFEMUR X m Stem

11 Neck Options Short Straight Long Straight Valgus Short Varus Short Valgus Long Varus Long Short Straight Leg Length Offset Leg Length Offset Leg Length Offset Leg Length Offset Leg Length Offset Long Straight Leg Length Offset Leg Length Offset Leg Length Offset Leg Length Offset Leg Length Offset Valgus Short Leg Length Offset Leg Length Offset Leg Length Offset Leg Length Offset Leg Length Offset Varus Short Leg Length Offset Leg Length Offset Leg Length Offset Leg Length Offset Leg Length Offset Valgus Long Leg Length Offset Leg Length Offset Leg Length Offset Leg Length Offset Leg Length Offset Varus Long Leg Length Offset Leg Length Offset Leg Length Offset Leg Length Offset Leg Length Offset Chart Rules:. Changing from a neutral neck to an anteverted/retroverted neck does not significantly change leg length or offset (as long as neck length stays the same). a.treat A/R 8 and A/R 5 necks just like straight necks. b.treat ARVV and ARVV2 necks just like varus or valgus necks, depending upon hip* 2. A change in femoral head neck length, increases or decreases both leg length and offset by 2.5mm (assuming no neck change). a. Going from a Medium head to a Long head, increases both leg length and offset by 2.5mm. b. Going from a Medium head to a Xtra Long head, increases both leg length and offset by 5mm. c. Going from a Medium head to a Xtra-Xtra Long head, increases both leg length and offset by 7.5mm. d. Going from a Medium head to a Short head, decreases both leg length and offset by 2.5mm. * Left Hip * Right Hip ARVV ARVV2 ARVV ARVV2 Anteverted/Valgus Retroverted/Varus Anteverted/Varus Retroverted/Valgus Anteverted/Varus Retroverted/Valgus Anteverted/Valgus Retroverted/Varus * Modular neck chart should be used to approximate changes in leg length and offset. Ultimately, final neck selection should be based on intraoperative evaluation of joint stability during trial reduction. Current Neck

12 Additional Products To Preserve Tissue, Use PATH Tissue-Preserving Total Hip Arthroplasty PATH - KIT3 PHRM KIT PBFH KIT PATH General instruments PATH Reamer baskets PATH BFH Suction Impactor and Alignment Handles P A T H (Percutaneous Assisted Total Hip Arthroplasty) Minimally Invasive Total Hip Arthroplasty SURGICAL TECHNIQUE MH PATH Surgical Technique MH PATH Surgical Animation DVD Wright Medical Technology, Inc Airline Road Arlington, TN phone toll-free Wright Medical EMEA Krijgsman 86 DM Amstelveen The Netherlands Trademarks and Registered marks of Wright Medical Technology, Inc. Covered by one or more of the following US Patents: 4,957,50. Patents pending Wright Medical Technology, Inc. All Rights Reserved. MH Rev. 8.08

13 PROFEMUR GLADIATOR Total Hip System S U R G I C A L T E C H N I Q U E PROFEMUR Total Hip System

14 why think modularity? Wright has 20 years experience with our modular neck system, changing a hip replacement into custom-made hip reconstruction for each patient. * * By using modular necks as a bridge between cup and stem choices, we can address many issues that face the surgeon in hip surgery. The options of changing the varus / valgus, anteverted / retroverted and lengths of the necks, will offer intraoperative solutions to issues such as: Stature-specific anatomy Soft tissue tension Accomodating the placement of implants, dictated by the patient s anatomy Visualization in limited access incisions Obviously in providing a solution to these issues we can see the benefits to the patient by observing a reduction in the post-operative complications: * * * Leg length discrepancy Hip dislocation Cup impingement leading to reduced range of motion and prosthesis wear The use of fixed neck implants in hip surgery can mean a surgeon needs to place implants in a sub-optimal position to address patient s anatomy. The use of Wright s modular necks means you need... Never Compromise. PROFEMUR Total Hip System

15 Contest Preface Chapter 6 Chapter Appendix A 7 Appendix B Appendix C 2 Design Rationale Design Features of the PROFEMUR GLADIATOR HA-Coated Stem Design Features of the PROFEMUR GLADIATOR Cemented Stem Design Features PROFEMUR GLADIATOR Plasma Stem Pre-operative Planning Surgical Technique Femoral Neck Osteotomy Femoral Canal Preparation Starter Reamer Starter Broach Femoral Broaching Calcar Planing Trial Reduction Summary of the Modular Neck Options Stem Insertion Final Trial Reduction Implant Assembly Technique Overview Implant Specification Ordering Information PROFEMUR GLADIATOR HA-Coated Collared Stems PROFEMUR GLADIATOR HA-Coated Collarless Stems PROFEMUR GLADIATOR Plasma Stems PROFEMUR GLADIATOR Cemented Stems PROFEMUR Modular Necks Instrumentation PROFEMUR GLADIATOR Total Hip System Proper surgical procedures and techniques are the responsibility of the medical professional. The following guidelines are furnished for information purposes only. Each surgeon must evaluate the appropriateness of the procedures based on his or her personal medical training and experience. Prior to use of the system, the surgeon should refer to the product package insert for complete warnings, precautions, indications, contraindications and adverse effects. Package inserts are also available by contacting Wright Medical Technology, Inc.

16 Design Rationale Preface To my orthopaedic colleagues, Over the last decades, Total Hip Arthroplasty has become a standard procedure. In order to obtain an optimal result, a perfect reconstruction and balance of the hip are essential. Simultaneous correction of leg length, offset, rotation, varus or valgus deformity seems to be impossible with one single hip system. After correct repositioning of the centre of rotation, modular necks are an essential tool for perfect hip reconstruction. Moreover, because of the diversity in proximal femoral geometry, one single stem design can no longer cover all cases. The PROFEMUR GLADIATOR Total Hip System was developed to offer a solution to these individual differences in the anatomy of the femoral canal. In order to deal with this variety in femoral canal index, the PROFEMUR GLADIATOR stems are available in four options: cemented, plasma sprayed, hydroxyapatite collared and hydroxyapatite collarless. This choice of femoral stem options with the PROFEMUR GLADIATOR Total Hip System combined with the Wright Medical Technology neck modularity is offering the surgeon a highly valuable tool to achieve optimal hip reconstruction even in challenging cases. Sincerely, Dr. Marc Goossens 2 PROFEMUR GLADIATOR Total Hip System

17 Abbreviated Technique: Broach Only Broach to templated size Implant size corresponding to broach size Ordering Information Templates PRGHXR5 Surgical EH E Technique Instruments PRGLKIT2 Implants PRGLKITC HA Collared Stems PRGLKITD HA Collarless Stems MONEKITA Modular Necks SUFIKITA Metal Heads CERAKITA Ceramic Heads Design Features of the PROFEMUR GLADIATOR HA-Coated Stems a STATURE product Modular Neck Geometry Reduced profile increases range of motion compared to standard fixed necks Material Both HA-Coated stems are made from forged Titanium Alloy (Ti6Al4V) Driving Platform Slotted driving platform for rotational control during stem insertion Lateral Shoulder Reduced material helps to conserve bone and ease insertion Collar Provides rotational stability and protection against subsidence Macrofeatures Provides additional rotational stability and maximizes compressive loading forces HA Coating Enhances osteointegration and fixation Common Instrumentation Utilizes same set of broaches for all stem versions Sizes Collared and collarless stems are available in sizes - 0 Reduced Tip To prevent mid-thigh pain PROFEMUR GLADIATOR Total Hip System 3

18 Design Feature of the PROFEMUR GLADIATOR Cemented Stem a STATURE product Abbreviated Technique: Broach Only Broach to templated size Implant size corresponding to broach size Ordering Information Templates PRGCXR5 Surgical Technique EH E Instruments PRGLKIT2 Implants PRGLKITA Cemented Stems MONEKITA Modular Necks SUFIKITA Metal Heads CERAKITA Ceramic Heads Collar Provides rotational stability and protection against subsidence Driving Platform Slotted driving platform for rotational control during stem insertion Lateral Shoulder Reduced material helps to conserve bone and ease insertion Modular Neck Geometry Reduced profile increases range of motion compared to standard fixed necks Matte finish Material Cemented stem is made from forged Cobalt Chrome Alloy Common Instrumentation Utilizes same set of broaches for all stem versions, with.5mm/side cement mantle built-in to cemented stem sizes Centralizers Available for each size of implant for a.5 mm distal circumferential cement mantle Sizes Cemented stems are available in 5 sizes ( ) Reduced Tip To prevent mid-thigh pain 4 PROFEMUR GLADIATOR Total Hip System

19 Design Features of the PROFEMUR GLADIATOR Plasma Stem a STATURE product Abbreviated Technique: Broach Only Broach to templated size Implant size corresponding to broach size Ordering Information Templates PRGPXR5 Surgical Technique EH E Instruments PRGLKIT2 Implants PRGLKITB Plasma Stems MONEKITA Modular Necks SUFIKITA Metal Heads CERAKITA Ceramic Heads Plasma Spray Provides additional mm press-fit (0.5mm/side) for initial stability and longterm on-growth Driving Platform Slotted driving platform for rotational control during stem insertion Lateral Shoulder Reduced material helps to conserve bone and ease insertion Macrofeatures Provides additional rotational stability and maximizes compressive loading forces Modular Neck Geometry Reduced profile increases range of motion compared to standard fixed necks Common Instrumentation Utilizes same set of broaches for all stem versions Material Plasma stems are made from forged Titanium Alloy (Ti6Al4V) Sizes Plasma stems are available in sizes - 0 Reduced Tip To prevent mid-thigh pain PROFEMUR GLADIATOR Total Hip System 5

20 Pre-operative Planning chapter NOTE: Accurate pre-operative templating requires good quality standardized radiographs of the pelvis and operative hip. Determine leg length discrepancy. Draw a line across the bottom of the ischium on the A/P view. The distance from this horizontal reference line to each lesser trochanter should then be measured. The difference between each measured side is the leg length discrepancy. If there is any asymmetry of the pelvis or if landmarks are not clear, other means to determine discrepancy should be used. Determine the femoral head center. Once the center of rotation for the acetabular component has been determined, the center of rotation for the femoral head should be determined. Superimpose the femoral stem templates sequentially on the A/P x-ray with the templates positioned neutrally along the longitudinal axis of the femur. Estimate the metaphyseal and diaphyseal fit and anticipated level of implant insertion using the templates. The approximate femoral size and length of the femoral neck cut can be estimated from the templates. Neck angle, neck length, and head length which most closely correspond to the patient s femoral head center can be estimated as well. The circles/squares found along the femoral neck axis represent the expected centers of rotation for the femoral head. For the ideal neck/head combination, the circle/square will align atop the previously determined center of rotation for the femoral head. In patients with significant deformity of the femoral head, templating can be performed on the opposite hip if necessary. Each circle represents the center of rotation for a modular short neck with the corresponding head option (short to XXlong). Each square represents the center of rotation for a modular long neck with the corresponding head option (short to XXlong). The circles/squares on the AP template of the stem illustrate the impact of choosing an 8 varus/valgus neck relative to the neutral neck position. NOTE: AR/VV necks can also affect neck position by 6 varus/valgus. The lateral x-ray illustrates the front to back fill of the implant and the position of the implant relative to the femoral anterior bow. If the anterior bow is high, the implant size may be reduced to minimize the risk of fracture. The lateral templates use circles/squares to compare the impact of choosing a neutral neck and necks with 8 or 5 anteversion/retroversion. Both the A/P and lateral views are needed to illustrate the impact of choosing an AR/VV neck because the combination necks provide multi-dimensional positioning. Each AR/VV neck provides 4 anteversion/retroversion and 6 varus/valgus. The impact of each AR/VV option ( or 2) depends upon which hip is being considered. Therefore, caution should be used to ensure that the appropriate combination is planned. CAUTION: Pre-operative templating is intended for estimation purposes only. Final component size and position should be determined intraoperatively. 6 Chapter Pre-operative planning

21 Surgical Technique chapter 2 Femoral Neck Osteotomy Using the greater trochanter or lesser trochanter as a reference, resect the neck at a 45 o angle to the longitudinal axis of the femur. Chapter 2 Surgical Technique 7

22 Femoral Canal Preparation Using the box chisel (P/N PRFS0450), open the femoral canal. The box chisel should be lateralized to ensure a neutral orientation of the implant. Starter Reamer Enter the femoral canal with the PROFEMUR GLADIATOR starter reamer (P/N PRGLREAM). Machined grooves along the surface of the starter reamer indicate the medial lengths of the corresponding stem sizes and reflect the proper depth at which to ream. Attach the T-handle onto the starter reamer, and ream to the appropriate depth according to pre-operative templating. Manual reaming of the femur using the quick disconnect T-handle (P/N K00006) is recommended to avoid over-reaming the canal, to maintain alignment control and to minimize the amount of heat generated. If powered reaming is preferred, the T-handle can be removed and the starter reamer inserted into any surgical drill. Reaming depth is measured from medial resection 8 Chapter 2 Surgical Technique

23 Starter Broach Prepare the femoral canal with the initial size zero PROFEMUR GLADIATOR Starter Broach (P/N PRGLSTBR). Stay centered between the anterior and posterior cortices. Insert the broach using impactions until it rests -2mm below the level of the neck resection. Chapter 2 Surgical Technique 9

24 Femoral broaching Attach the Broach Handle (P/N PPW38078) to the size PROFEMUR GLADIATOR broach (P/N PRGLBR0). Using a mallet with short, controlled strokes, begin broaching. Sequentially increase the broach sizes while broaching (P/Ns PRGLBR0 - PRGLBR2). Throughout broaching, continue to apply lateral pressure to ensure neutral alignment of the implant. Continue broaching until an optimal fit is found. This will be denoted by a change in tone or resistance as the rounded corners of the broach contact the cortical bone of the femur. 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. At this point, leave the broach fully seated in the canal and detach the broach handle to allow for trial reduction. NOTE: Rasp sizes and 2 are to be used for cemented application only. Cementless stems have been dimensioned across the M/L width with a mm increment between sizes, except between size and Cemented stems are dimensioned as the corresponding cementless sizes and implanted with bigger rasps. However, to facilitate the implantation, the stems are labeled as the corresponding rasps used during surgery. This will guarantee a uniform.5mm cement mantle thickness around the entire stem length. Stem Label Rasp used to implant The broach handles show a scale to assist in determining the seating of the broach (and therefore the corresponding implant) in relation to the tip of the greater trochanter. The outcome can be compared with the preferred implant size/position determined during pre-planning. Potential differences between broaches and templated sizes: The quality of bone plays an integral role in sizing. For soft bone, the broach may seat further than the template indicates. An implant larger than the templated size may be required. Patients with strong, healthy bone might require an implant smaller than the templated size. 0 Chapter 2 Surgical Technique

25 If a broach smaller than the size templated becomes tight, hard bone at the lateral femoral neck may be pushing the broach into varus. Use the lateral edge of the broach to restore a neutral position. Additional broaching may be necessary. If a broach is going in straight and becomes tight with sizes smaller than those templated, a repetitive in/out broach motion may clear excess medial and lateral bone. If still tight, the stem should be appropriately downsized until metaphyseal bone is engaged. Calcar Planing For collared stems, finish preparing the femur with the calcar planer (P/N 4700CP0000 and PRGLPOST). The calcar planer provides a reliable, effective, and accurate cutting instrument for the removal of hard calcar bone. Insert the PROFEMUR GLADIATOR centralizer post (P/N PRGLPOST) into the broach pocket. Attach the calcar planer to the drill and load onto the guide. When planing, be sure to have the planer rotating prior to contacting the bone. With the built-in stop mechanism, the planer will stop at the appropriate level. Chapter 2 Surgical Technique

26 Trial Reduction Select the appropriate PROFEMUR metal trial neck (P/Ns APA202 APA254) and trial head and perform a trial reduction. Once a well-balanced hip has been created with a trial head and trial neck, remove the broach. TIP: The choice of neck anteversion is based on intraoperative assessment of stability. The head/neck combination that allows maximal flexion/internal rotation and extension/external rotation without dislocation should be chosen. Brief Summary of Neck Options Straight necks create a neutral neck axis (35 ) Varus necks decrease the inclination angle to 27 or 20 (neutral position is 35 ); the femoral head shifts medially and inferiorly; leg length is shortened; offset is increased. Valgus necks increase the inclination angle to 43 or 50 ; the femoral head shifts laterally and superiorly; leg length is increased; offset is decreased. Anteverted necks shift the femoral head anteriorly relative to the stem by 8 or 5. Retroverted necks shift the femoral head posteriorly relative to the stem by 8 or 5. Retroverted necks prove useful in hips with excess femoral anteversion such as DDH. AR/VV necks combine anteversion/retroversion and varus/valgus necks to offer a broad range of multi-dimensional head positions. Each AR/VV neck provides 4 of A/R and 6 of V/V. 2 Chapter 2 Surgical Technique

27 Stem Insertion Cementless The stem is inserted with the special stem impactor (P/N APA04). Use the screwdriver (PP275400) to fix the implant in the impactor. The PROFEMUR screwdriver inserter ( PRFS0460) can be used for final seating of the component. Note: When using a collarless implant the build up offset portion of the implant should not be completely impacted. The implant should be seated so that the base of the polished neck is at depth equivalent to the resection level. Note: For the PROFEMUR GLADIATOR Plasma Spray version, the implant may sit - 2mm more proud than templated due to the additional 0.5mm thickness per side of the plasma spray. The difference can be addressed during the final trial reduction by selecting the proper head and neck combination. Warning: P/N APA09028 is a plastic pusher instrument intended to be used for cement application only to hold the stem in place while cement is curing. Do not use this instrument for impaction purposes or cementless application. Chapter 2 Surgical Technique 3

28 Stem Insertion (continued) Cemented The femoral bone bed is cleaned and bone cement is prepared and introduced into the femoral canal according to standard recommendations. Each femoral component is packaged with a distal centralizer. Place the centralizer onto the distal stem and affix by applying light pressure. Note: The molded arrows on the edges of the centralizers are to point proximally and be oriented on the medial and lateral sides of the stem. The stem is inserted using the special stem impactor (APA04). Use the screwdriver (PP275400) to fix the implant in the impactor. The implant pusher (APA09028) can be used to stabilize the stem during the curing of the cement. Final Trial Reduction Perform a final reduction using the trial necks and trial heads to reconfirm stability, range of motion and leg length. Select the appropriate PROFEMUR Metal Trial Neck ( APA202 APA254) and trial head and perform a trial reduction. Once a well-balanced hip has been created with a trial head and trial neck you can introduce the final neck and head implant. These metal trial heads are not intended to be used as a final implant. 4 Chapter 2 Surgical Technique

29 Implant Assembly Modular neck clinical experience and extensive laboratory tests have demonstrated the coupling between the modular neck and femoral implant, when properly assembled, provides: structural reliability, absence of significant micromovement, and absence of fretting corrosion.* To properly assemble and impact a Profemur Modular Neck the following procedure is recommended Step. Ensure that both the stem and neck are clean and dry prior to assembly. Suction any fluid from the stem implant pocket. Step 2. Insert the oval end of the appropriate femoral neck implant into the femoral stem pocket. Step 3. Position the leg such that the knee is supported by an assistant on the opposite side of the table. By resting the patient s knee against the mid-section of the assistant, this will provide counter-force against the mallet blows to ensure the impaction load transfer to the neck junction. Step 4. Affix the femoral head to the neck. Using the head impactor instrument (P/N PPR67702), strike the impactor with three very firm blows with a two pound mallet to securely fix the head to the neck and stem. Note: If using a ceramic head, push and turn the head 80 0 to securely lock it in place. There is no need to further impact the head for secure seating. *WMT Data on file Chapter 2 Surgical Technique 5

30 Technique Overview. Femoral Neck Osteotomy 2. Box Osteotome 3. Starter Reamer 4. Starter Broach 5. Femoral Broaching 6. Calcar Planing 7. Trial Reduction 8. Cementless Stem Insertion 9. Cemented Stem Insertion 0. Modular Neck & Femoral Head Assembly 6 Chapter 2 Surgical Technique

31 Implant Specification Appendix A PROFEMUR Gladiator Stems a STATURE product General Specifications»» Titanium material (cementless stems)»» CoCr material (cemented stems)»» Medial Width: mm»» A/P Thickness: 2-9 mm Dimensional Chart - PROFEMUR GLADIATOR Stems (mm) Cementless Size Cemented Size Medial Length Lateral Length M/L Calcar Width A/P Thickness M/L Width Medial Stem Length Lateral Stem Length Appendix A Implant Specification 7

32 Ordering Information Appendix B PROFEMUR GLADIATOR HA-Coated Collared Stems a STATURE product PRGLKITC Catalog # Description Size PRGLHA0 HA Stem with Collar Size PRGLHA02 HA Stem with Collar Size 2 PRGLHA03 HA Stem with Collar Size 3 PRGLHA04 HA Stem with Collar Size 4 PRGLHA05 HA Stem with Collar Size 5 PRGLHA06 HA Stem with Collar Size 6 PRGLHA07 HA Stem with Collar Size 7 PRGLHA08 HA Stem with Collar Size 8 PRGLHA09 HA Stem with Collar Size 9 PRGLHA0 HA Stem with Collar Size 0 PROFEMUR GLADIATOR HA-Coated Collarless Stems a STATURE product PRGLKITD Catalog # Description Size PRGLHA HA Stem no collar Size PRGLHA2 HA Stem no collar Size 2 PRGLHA3 HA Stem no collar Size 3 PRGLHA4 HA Stem no collar Size 4 PRGLHA5 HA Stem no collar Size 5 PRGLHA6 HA Stem no collar Size 6 PRGLHA7 HA Stem no collar Size 7 PRGLHA8 HA Stem no collar Size 8 PRGLHA9 HA Stem no collar Size 9 PRGLHA20 HA Stem no collar Size 0 8 Appendix B Ordering Information

33 PROFEMUR GLADIATOR Plasma Stems a STATURE product PRGLKITB Catalog # Description Size PRGL000 Plasma Stem Size PRGL0002 Plasma Stem Size 2 PRGL0003 Plasma Stem Size 3 PRGL0004 Plasma Stem Size 4 PRGL0005 Plasma Stem Size 5 PRGL0006 Plasma Stem Size 6 PRGL0007 Plasma Stem Size 7 PRGL0008 Plasma Stem Size 8 PRGL0009 Plasma Stem Size 9 PRGL000 Plasma Stem Size 0 PROFEMUR GLADIATOR Cemented Stems a STATURE product PRGLKITA Catalog # Description Size PRGLCM04 Cemented Stem Size 4 PRGLCM06 Cemented Stem Size 6 PRGLCM08 Cemented Stem Size 8 PRGLCM0 Cemented Stem Size 0 PRGLCM2 Cemented Stem Size 2 Package includes Distal Centralizers Catalog # Description Size PRGLDC04 Distal Centralizer Size 4 PRGLDC06 Distal Centralizer Size 6 PRGLDC08 Distal Centralizer Size 8 PRGLDC0 Distal Centralizer Size 0 PRGLDC2 Distal Centralizer Size 2 Appendix B Ordering Information 9

34 PROFEMUR Modular Necks a STATURE product MONEKITA Catalog # PHA0202 PHA0204 PHA0206 PHA0252 PHA0254 PHA0256 PHA0262 PHA0264 PHA0232 PHA0234 PHA0236 PHA0242 PHA0244 PHA0222 PHA0224 PHA022 PHA024 Modular Neck Straight Short Straight Long Straight X-Long Varus / Valgus 8 Short Varus / Valgus 8 Long Varus / Valgus 8 X-Long Varus / Valgus 5 Short Varus / Valgus 5 Long Ante / Retro 8 Short Ante / Retro 8 Long Ante / Retro 8 X-Long Ante / Retro 5 Short Ante / Retro 5 Long Ante / Retro - Varus /Valgus Short Ante / Retro - Varus /Valgus Long Ante / Retro - Varus /Valgus 2 Short Ante / Retro - Varus /Valgus 2 Long 20 Appendix B Ordering Information

35 Instrumentation PRGLKIT2 Appendix C Starter Broach Centralizer Post Calcar Planer Trial Modular Necks Broach Handle Extraction Ring Broaches Quick Disconnect T-handle Starter Reamer Box Chisel Appendix C Instrumentation 2

36 Cemented Stem Pusher Screwdriver Impactor Modular Necks Inserter Trial Heads mm Head Impactor Stem Inserter Hex Screwdriver 22 Appendix C Instrumentation

37 PROFEMUR GLADIATOR Instruments PRGLKIT2 Catalog # Description Quantity PRGLBR0 PRGLBR02 PRGLBR03 PRGLBR04 PRGLBR05 PRGLBR06 PRGLBR07 PRGLBR08 PRGLBR09 PRGLBR0 PRGLBR PRGLBR2 PROFEMUR GLADIATOR Broach Size PROFEMUR GLADIATOR Broach Size 2 PROFEMUR GLADIATOR Broach Size 3 PROFEMUR GLADIATOR Broach Size 4 PROFEMUR GLADIATOR Broach Size 5 PROFEMUR GLADIATOR Broach Size 6 PROFEMUR GLADIATOR Broach Size 7 PROFEMUR GLADIATOR Broach Size 8 PROFEMUR GLADIATOR Broach Size 9 PROFEMUR GLADIATOR Broach Size 0 PROFEMUR GLADIATOR Broach Size PROFEMUR GLADIATOR Broach Size CP0000 PERFECTA Power Calcar Planer PRGLPOST PRGLREAM PRGLSTBR PROFEMUR GLADIATOR Centralizer Post PROFEMUR GLADIATOR Starter Reamer PROFEMUR GLADIATOR Starter Broach K00006 Quick Disconnect T-Handle PPW38078 Broach Handle PRFS0450 Box Chisel PPR67702 Head Impactor PRFS0460 PROFEMUR Screwdriver Inserter APA04 Stem Guide Impactor PP Hex Screwdriver PPG3070 Extraction Ring APA09028 Cemented Stem Pusher Modular Neck Inserter Appendix C Instrumentation 23

38 Catalog # Description Quantity APA202 PROFEMUR Metal Trial Neck Straight Short APA204 PROFEMUR Metal Trial Neck Straight Long APA206 PROFEMUR Metal Trial Neck Straight X-Long APA22 PROFEMUR Metal Trial Neck AR/VV Short APA24 PROFEMUR Metal Trial Neck AR/VV Long APA222 PROFEMUR Metal Trial Neck AR/VV 2 Short APA224 PROFEMUR Metal Trial Neck AR/VV 2 Long APA232 PROFEMUR Metal Trial Neck AR 80 Short APA234 PROFEMUR Metal Trial Neck AR 80 Long APA236 PROFEMUR Metal Trial Neck AR 80 X-Long APA242 PROFEMUR Metal Trial Neck AR 50 Short APA244 PROFEMUR Metal Trial Neck AR 50 Long APA252 PROFEMUR Metal Trial Neck VV 80 Short APA254 PROFEMUR Metal Trial Neck VV 80 Long APA256 PROFEMUR Metal Trial Neck VV 80 X-Long APA262 PROFEMUR Metal Trial Neck VV 50 Short APA264 PROFEMUR Metal Trial Neck VV 50 Long 24 Appendix C Instrumentation

39 Catalog# Description Quantity APA022 Femoral Head Trial 28mm Short -3,5 APA0222 Femoral Head Trial 28mm Medium 0 APA0223 Femoral Head Trial 28mm Long +3,5 APA023 Femoral Head Trial 32mm Short -4 APA0232 Femoral Head Trial 32mm Medium 0 APA0233 Femoral Head Trial 32mm Long +4 APA0242 Femoral Head Trial 36mm Short -3,5 APA0244 Femoral Head Trial 36mm Medium 0 APA0246 Femoral Head Trial 36mm Long +3,5 Catalog# Description Quantity PRGCXR5 PRGHXR5 PRGPXR5 PROFEMUR GLADIATOR Cemented Stem X-ray Template 5% Magnification PROFEMUR GLADIATOR HA-Coated Stem X-ray Template 5% Magnification PROFEMUR GLADIATOR Plasma Spray Stem X-ray Template 5% Magnification Appendix C Instrumentation 25

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