Regenerex Primary Tibial Tray

Transcription

1 Cruciate Retaining and Posterior Stabilized Surgical Technique Addendum to the Vanguard Complete Knee System Knees Hips Extremities Cement and Accessories PMI Technology

2 Contents Microplasty Knee Instrumentation Tibial Resection... 1 Final Tibial Preparation... 1 Modular Press-ft Splined Stem Guide/Splined Stem Trial... 2 Tibial Implant Insertion... 3 Premier Knee Instrumentation Tibial Resection... 4 Final Tibial Preparation... 5 Modular Press-ft Splined Stem Guide/Splined Stem Trial... 6 Tibial Implant Insertion... 7 Ordering Information Implants... 8 Instruments... 8

3 Figure 1 Figure 2 Microplasty Knee Instrumentation Tibial Resection Using Microplasty knee instrumentation and following the appropriate technique, establish the tibial cutting platform and make a fat, proximal tibial resection. Ensure that the resected bone surface is at and free of bone fragments. Proceed with the following steps to prepare the tibia for implanting the Vanguard cruciate retaining, cruciate retaining lipped, anterior stabilized or posterior stabilized bearing with the. This surgical technique is utilized by Christopher Peters, M.D. Biomet as the manufacturer of this device, does not practice medicine and does not recommend this device or technique. Each surgeon is responsible for determining the appropriate device and technique to utilize on each individual patient. Final Tibial Preparation Place the knee in maximum fexion and sublux the tibia slightly anteriorly. Select the tibial template (59, 63, 67, 71, 75, 79 or 83) that provides the appropriate coverage in both the anterior-posterior and the medial-lateral planes (Figure 1). Rotation should be based upon positioning relative to the tibial tubercle and the malleolar axis. Check alignment by placing the extramedullary alignment rod through the tibial template handle (Figure 2). Slight external rotation is preferable to optimize patellofemoral tracking. Pin the template in place with 1 8 inch bone nails. This will also prepare for the Regenerex tray s square pegs. Note: Extra caution should be taken to avoid internal rotation of the tibial tray due to the presence of lateral soft tissue. 1

4 Figure 3 Figure 4 Figure 5 Modular Press- t Splined Stem Guide/ Splined Stem Trial Assemble the square I-beam punch guide mask and splined core punch bushing onto the tibial template and pin in place using 1 8 inch bone nails (Figure 3). Use the splined core punch prior to the splined stem body punch (Figure 4). Use a mallet to carefully drive the fnish splined stem body punch through the square I-beam punch guide mask (Figure 5). Insert the trial tibial tray in place, while using the 40mm splined Microplasty trial (Figure 6). Note: Use the appropriate punch for cruciate fn tibial stem preparation Vanguard Microplasty Cruciate Punch 2

5 Figure 6 Figure 7 Tibial Implant Insertion Assemble the modular stem and tibial tray by impacting the stem onto the tray taper junction. Ensure that alignment keys match exactly. Using a hex driver, secure this junction with a screw using a 3.5mm hex screwdriver. Note: The 1 8 inch bone nails are used to stabilize the tibial template and as pilot holes for the actual implant s square pegs. Impact the tray into the tibial plateau in the routine fashion, paying special attention to peg placement and prepared peg holes (Figure 7). 3

6 Figure 1 Figure 2 Premier Knee Instrumentation Tibial Resection Using Premier knee instrumentation and following the appropriate technique, establish the tibial cutting platform and make a fat, proximal tibial resection. Ensure that the resected bone surface is at and free of bone fragments. Proceed with the following steps to prepare the tibia for implanting the Vanguard cruciate retaining, cruciate retaining lipped, anterior stabilized or posterior stabilized bearing with the. 4

7 Figure 3 Final Tibial Preparation Place the knee in maximum fexion and sublux the tibia anteriorly. Attach the alignment tower/handle to the medial side of the trial tray. Select the tibial tray that provides the greatest amount of coverage in both the medial-lateral and anterior-posterior planes (59, 63, 67, 71, 75, 79, or 83) (Figure 1). Rotation should be based upon positioning relative to the tibial tubercle and the malleolar axis. Check alignment by placing the extramedullary alignment rod through the lateral hole on the tibial baseplate handle (Figure 2). Slight external rotation is preferable to optimize patellofemoral tracking. An initial trial reduction can be performed to confrm proper rotation. When correct rotation has been determined, the tibial tray can be marked with electrocautery and stabilized using short fxation pins to prepare for Regenerex Primary Tibial Tray pegs (Figure 3). 5

8 Figure 4 Figure 5 Modular Press- t Splined Stem Guide/ Splined Stem Trial Use the quick-release lock to assemble the tower guide to the tibial template (Figure 4). If prepping for a 40mm splined stem, introduce the splined modular core punch to provide an initial hole into the tibia before the splined modular body punch is used (Figures 4 and 5). Carefully drive each punch into the guide until it mechanically stops (a mechanical stop is designed to provide the correct punching depth). Note: Use the appropriate punch for I-beam or cruciate fn tibial stem preparation Vanguard I-beam Punch Head Trial Vanguard Cruciate Punch Trial Once the correct punch has been identifed, attach the punch head by pressing the button on top of the handle. 6

9 Figure 6 Figure 7 Figure 8 If prepping for an 80mm splined stem, introduce the 80mm splined stem reamer through the tower guide (Figure 6). After the punch is fully seated, press the button on top of the punch handle to release the splined body punch. The 40mm punch head will sit in the tibial trial plate and act as the trial stem for 40mm or 80mm stems (Figure 7). Tibial Implant Insertion Assemble the modular stem and tibial tray by impacting the stem onto the tray taper junction checking that alignment keys match exactly. Using a hex driver, secure this junction with a screw using a 3.5mm hex screwdriver. Impact the tray into the tibial plateau in the traditional fashion, paying special attention to peg placement and prepared peg holes (Figure 8). 7

10 Implants Product Part Number Description Size mm 63mm 67mm 71mm 75mm 79mm 83mm Modular Press-ft Stem Modular Press-ft Stem 40mm 80mm Instruments Product Part Number Description Size Microplasty Splined Core Punch Bushing Microplasty Splined Core Punch Microplasty Splined Stem Body Punch Premier Splined Stem Reamer 80mm Premier Splined Modular Core Punch Premier Splined Modular Body Punch Microplasty Regenerex Splined Trial Stem 8

11 Biomet Orthopedics, Inc East Bell Drive Date: 02/08 P.O. Box 587 Warsaw, Indiana USA Biomet Knee Joint Replacement Prostheses ATTENTION OPERATING SURGEON DESCRIPTION Biomet manufactures a variety of knee joint replacement prostheses intended for application with or without bone cement. Knee joint replacement components include femoral, tibial, and patellar components. Components are available in a variety of designs and size ranges intended for both primary and revision applications. Specialty components are available including; femoral stems, femoral augments, tibial stems, tibial augments, tibial cement plugs and tibial screws. Materials Femoral Components Tibial Plates Tibial Bearings Patellar Components Femoral Stems Augment Components Stem Components Tibial Cement Plugs Tibial Screws Modular Pegs CoCrMo Alloy/Titanium Alloy CoCrMo Alloy/Titanium Alloy Ultra-High Molecular Weight Polyethylene (UHMWPE) UHMWPE/Titanium Alloy/316LVM Stainless Steel Titanium Alloy Titanium Alloy Titanium Alloy UHMWPE Titanium Alloy CoCrMo Alloy INDICATIONS 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. The Regenerex femoral augments are indicated for use with the Vanguard Total Knee System. The Regenerex tibial augments are indicated for use with standard and offset Biomet Tibial Trays. Patient selection factors to be considered include: 1) need to obtain pain relief and improve function, 2) ability and willingness of the patient to follow instructions, including control of weight and activity level, 3) a good nutritional state of the patient, and 4) the patient must have reached full skeletal maturity. Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fxation application. Non-coated (Interlok ) devices and all-polyethylene patellar components are indicated for cemented application only. CONTRAINDICATIONS Absolute contraindications include: infection, sepsis, and osteomyelitis. Relative contraindications include: 1) an uncooperative patient or a patient with neurologic disorders who is incapable of following directions, 2) osteoporosis, 3) metabolic disorders which may impair bone formation, 4) osteomalacia, 5) distant foci of infections which may spread to the implant site, 6) rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, 7) vascular insuffciency, muscular atrophy, neuromuscular disease, and/or 8) incomplete or defcient soft tissue surrounding the knee. Biomet Microplasty Tibial Trays are contraindicated for use with constrained bearings. WARNINGS Improper selection, placement, positioning, alignment and fxation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components. Malalignment of the components or inaccurate implantation can lead to excessive wear and/or failure of the implant or procedure. Inadequate preclosure cleaning (removal of surgical debris) can lead to excessive wear. Use clean gloves when handling implants. Laboratory testing indicates that implants subjected to body fuids, surgical debris or fatty tissue have lower adhesion strength to cement than implants handled with clean gloves. Improper preoperative or intraoperative implant handling or damage (scratches, dents, etc.) can lead to crevice corrosion, fretting, fatigue fracture and/or excessive wear. Do not modify implants. The surgeon is to be thoroughly familiar with the implants and instruments prior to performing surgery. 1. The 23mm Single-Peg Patella components should be used only with an inset mill surgical technique. Product numbers for the 23mm Single-Peg Patella components include the following: CP112895, CP112896, and CP The shorter titanium locking screws, Catalogue Number B (Performance Locking Screw), is to be used with the cruciate-retaining and cruciate-supplementing articulating surfaces. The longer P/S Locking Screw, Catalogue Number B (Performance P/S Locking Screw), is to be used with the P/S cruciate and constrained substituting articulating surface. 3. The locking bar used to secure the tibial plate and tibial-bearing components together must lock securely into place with an audible click at the time of implantation. Disassociation of the locking bar from the modular tibial plate component has been reported. Inadequate seating of the locking bar can cause disassociation of the locking bar from the tibial plate component, requiring revision surgery. 4. The 8mm-polyethylene insert of the modular tibial is not compatible with the AGC posterior stabilized and revision AGC femoral components. Product numbers for the 8mm-polyethylene insert bearing components include the following: , , , , , , , , and The all-polyethylene tibial component is designed to be used in treatment of low demand, less active sedentary patients. Patients that will remain active and/or overweight are not candidates for all- polyethylene tibial components. 6. Malalignment or soft tissue imbalance can place inordinate forces on the components, which may cause excessive wear to the patellar or tibial bearing articulating surfaces. Revision surgery may be required to prevent component failure. 7. Care is to be taken to assure complete support of all parts of the device embedded in bone cement to prevent stress concentrations, which may lead to failure of the procedure. Complete preclosure cleaning and removal of bone cement debris, metallic debris, and other surgical debris at the implant site is critical to minimize wear of the implant articular surfaces. Implant fracture due to cement failure has been reported. 8. It is the responsibility of the operating surgeon to determine whether there is adequate initial fxation and stability. Stem extension and bone cement are available if additional fxation or stability are needed. 9. The Regenerex Tibial Trays require a stem when used with PS components. Biomet joint replacement prostheses provide the surgeon with a means of reducing pain and restoring function for many patients. While these devices are generally successful in attaining these goals, they cannot be expected to withstand the activity levels and loads of normal healthy bone and joint tissue. Accepted practices in postoperative care are important. Failure of the patient to follow postoperative care instructions involving rehabilitation can compromise the success of the procedure. The patient is to be advised of the limitations of the reconstruction, and the need for protection of the implants from full load bearing until adequate fxation and healing have occurred. Excessive activity, trauma and excessive weight have been implicated with premature failure of the implant by loosening, fracture, and/or wear. Loosening of the implants can result in increased production of wear particles, as well as accelerate damage to bone, making successful revision surgery more diffcult. The patient is to be made aware and warned of general surgical risks, possible adverse effects as listed, and to follow the instructions of the treating physician including follow-up visits. PRECAUTIONS Specialized instruments are designed for Biomet joint replacement systems to aid in the accurate implantation of the prosthetic components. The use of instruments or implant components from other systems can result in inaccurate ft, sizing, excessive wear and device failure. Intraoperative fracture or breaking of instruments has been reported. Surgical instruments are subject to wear with normal usage. Instruments, which have experienced extensive use or excessive force, are susceptible to fracture. Surgical instruments should only be used for their intended purpose. Biomet recommends that all instruments be regularly inspected for wear and disfgurement. Do not reuse implants. While an implant may appear undamaged, previous stress may have created imperfections that would reduce the service life of the implant. Do not treat patients with implants that have been, even momentarily, placed in a different patient. POSSIBLE ADVERSE EFFECTS 1. Material sensitivity reactions. Implantation of foreign material in tissues can result in histological reactions involving various sizes of macrophages and fbroblasts. The clinical signifcance of this effect is uncertain, as similar changes may occur as a precursor to or during the healing process. Particulate wear debris and discoloration from metallic and polyethylene components of joint implants may be present in adjacent tissue or fuid. It has been reported that wear debris may initiate a cellular response resulting in osteolysis, or osteolysis may be a result of loosening of the implant. 2. Early or late postoperative infection and allergic reaction. 3. Intraoperative bone perforation or fracture may occur, particularly in the presence of poor bone stock caused by osteoporosis, bone defects from previous surgery, bone resorption, or while inserting the device. 4. Loosening or migration of the implants can occur due to loss of fxation, trauma, malalignment, bone resorption or excessive activity. 5. Periarticular calcifcation or ossifcation, with or without impediment of joint mobility. 6. Inadequate range of motion due to improper selection or positioning of components. 7. Undesirable shortening of limb. 8. Dislocation and subluxation due to inadequate fxation and improper positioning. Muscle and fbrous tissue laxity can also contribute to these conditions. 9. Fatigue fracture of component can occur as a result of loss of fxation, strenuous activity, malalignment, trauma, non-union, or excessive weight. 10. Fretting and crevice corrosion can occur at interfaces between components. 11. Wear and/or deformation of articulating surfaces. 12. Valgus-varus deformity. 13. Transient peroneal palsy secondary to surgical manipulation and increased joint movement has been reported following knee arthroplasty in patients with severe fexion and valgus deformity. 14. Patellar tendon rupture and ligamentous laxity. 15. Interoperative or postoperative bone fracture and/or postoperative pain. STERILITY Prosthetic components are sterilized by exposure to a minimum dose of 25 kgy of gamma radiation. Do not resterilize. Do not use any component from an opened or damaged package. Do not use implants after expiration date. Caution: Federal law (USA) restricts this device to sale, distribution, or use by or on the order of a physician. Comments regarding the use of this device can be directed to Attn: Regulatory Affairs, Biomet, Inc., P.O. Box 587, Warsaw, IN USA, Fax: Biomet and all other trademarks herein are the property of Biomet, Inc. or its subsidiaries. Authorized Representative: Biomet U.K., Ltd. Waterton Industrial Estate Bridgend, South Wales CF31 3XA UK 0086 The information contained in this package insert was current on the date this brochure was printed. However, the package insert may have been revised after that date. To obtain a current package insert, please contact Biomet at the contact information provided herein.

12 All trademarks herein are the property of Biomet, Inc. or its subsidiaries unless otherwise indicated. This material is intended for the sole use and beneft of the Biomet sales force and physicians. It is not to be redistributed, duplicated or disclosed without the express written consent of Biomet. For product information, including indications, contraindications, warnings, precautions and potential adverse effects, see the package insert herein and Biomet s website. P.O. Box 587, Warsaw, IN ext Biomet Orthopedics Form No. BOI REV123108