Regenerex Ringloc Surgical Technique

REGENEREX RINGLOC+ MODULAR ACETABULAR SYSTEM SURGICAL TECHNIQUE – PRIMARY PROCEDURE Fig. 1 This technique is presented to demonstrate the surgical technique utilized by Michael Berend, M.D., of Mooresville, IN; and Kevin Garvin, M.D., of Omaha, NE. Biomet, as the manufacturer of this medical device, does not practice medicine and does not recommend this or any other surgical technique for use on a specific patient. The surgeon who performs any implant procedure is responsible for determining and utilizing the appropriate techniques for implanting the prosthesis in each individual patient. Biomet is not responsible for selection of the appropriate surgical technique to be utilized for an individual patient. ACETABULAR PREPARATION Prepare the acetabulum utilizing acetabular reamers, while maintaining the appropriate amount of anteversion and abduction as desired (Figure 1). Often with acetabular defects in the revision setting, less reaming is necessary. Once reaming is complete, use the cup trials to confirm the position and accuracy of the reaming. Once the desired ream has been achieved, select the implant 1–2mm larger than the final ream. Example: Ream to 54 or 55mm, implant 56mm. This will provide 1–2mm of press-fit for the implant. Fig. 2 Fig. 3 SHELL INSERTION Thread the inserter into the apical hole of the implant and impact it into the acetabulum (Figures 2 and 3). While impacting, note the position of the screw holes to obtain the optimal position for screw placement. When positioning the cup, note the placement of the liner unlock mechanism. The unlock mechanism is located between the dimpled anti-rotation tabs in all cup configurations. It should be placed superior/posterior (Figure 3). The RingLoc®+ opening is placed at the superior portion of the cup to assist with screw hole orientation. Fig. 4 Fig. 5 Fig. 6 SCREW INSERTION If screw fixation is desired, use the drill guide to drill a pilot hole in the desired screw hole (Figure 4). Measure the depth of the hole with the depth gauge, select the 6.5mm screw with the corresponding length and insert it into the hole with the screwdriver (Figure 5). Place additional screws as needed (Figure 6). Inferior or ischial screw holes are present if ischial fixation is desired. Fig. 7 Fig. 8 Superior Inferior RING ALIGNMENT Prior to inserting the liner, verify that the locking ring is properly aligned as shown in Figures 7 and 8. Liner trials or the appropriately sized polyethylene liner can be used before trialing the neck length for the femoral component. NOTE: After impacting the polyethylene, the ring should rotate freely side to side (with probe). Fig. 9 TRIAL REDUCTION Once the liner is locked into the final position, a trial or final femoral reduction can be performed (Figure 9). Fig. 11 Fig. 10 Fig. 12 LINER REVISION If it is necessary to remove the liner from the cup, the liner removal tool can be used to open the ring and then lever out the liner. To remove a liner, insert the liner removal tool into the cup as shown in Figures 10, 11 and 12. The insertion of the tool will expand the lock ring. Lever the handle of the tool outward while maintaining downward pressure with the tool. NOTE: Anytime the liner is removed, it is recommended that the locking ring is removed and replaced with a new one. If the liner is damaged in any way, a new liner should be utilized. Fig. 1 Fig. 2 Fig. 3 ACETABULAR PREPARATION Remove existing acetabular component(s) using contemporary techniques, conserving as much bone as possible (Figure 1). Once the component is removed, careful evaluation of the acetabulum is suggested, with close attention to the integrity of the anterior/posterior columns and the medial wall. Curette and irrigate any osteolytic cysts. Prepare the acetabulum with acetabular reamers, maintaining the appropriate amount of anteversion and abduction as desired (Figure 2). Ream only the amount of bone necessary to create an adequate hemispherical cavity for support of an acetabular shell, while maintaining the integrity of both columns and the medial wall (Figure 3). NOTE: The final implant should be 2mm larger than the last reamer size used. Once the acetabulum has been evaluated, it should be decided whether or not augmentation of the acetabular shell is necessary. The trial shell can be utilized to determine stability with anterior-posterior and superior-inferior displacement which simulates cup stability. If it is decided to utilize augmentation, the augment should be placed before implanting the acetabular shell. Fig. 4 Fig. 5 Fig. 6 AUGMENT PLACEMENT If augmentation of the acetabulum is required, it will be necessary to prepare the site for augment placement (Figure 4). The defect can be prepared using acetabular reamers to match the corresponding augment size (52–58mm, 2mm increments) (Figure 5). Posterior defects should be carefully prepared to protect the sciatic nerve if reamers are utilized. Once the defect has been prepared, use the augment provisionals to determine the necessary size to fill the defect and aid in cup stability. NOTE: Augment provisionals have an offset inner surface when compared with the final implant. This offset is 2mm and will replicate the spacing required for the cement mantle. Once the augment size is determined, place the implant, utilizing the augment holding instrument and a shell gauge. The shell gauge is designed to allow for proper sizing of the augment and cup implant. The shell gauge is windowed, allowing for visualization of augment placement with respect to desired cup position. Use the drill guide to drill a pilot hole in the desired screw hole (Figure 6). Measure the depth of the hole with the depth gauge, select the 6.5mm screw with the corresponding length and insert it into the hole with the screwdriver (Figure 7). Additional screws can also be placed for added stability of the implant. Fig. 7 Fig. 8a Fig. 8b without augment with augment SHELL SIZING AND POSITIONING After the acetabulum has been prepared, it is necessary to evaluate the stability of the implants by using the shell gauges (Figures 8a and 8b). The shell gauge used should match the size of the last reamer used. The final implant should be 2mm larger than the last reamer used. EXAMPLE: If the last reamer size used is 60mm, utilize a 60mm trial and the final implant should be 62mm. This will provide a 2mm press fit. Fig. 9 Fig. 10a Fig. 10b SHELL INSERTION If augments were used, a 1–2mm layer of bone cement is required between the cup and the augment(s). Prior to cementing, bone graft can be inserted into remaining cavitary defects. Place cement on the inferior surface of the augment prior to placement of the shell (Figure 9). Prior to inserting the liner, verify that the locking ring is properly aligned. Liner trials or the appropriately sized polyethylene liner can be used before trialing the neck length for the femoral component. Impact the shell (Figures 10a and 10b). NOTE: Do not use ball impactors to seat implant. Fig. 11 SCREW INSERTION If screw fixation is desired, use the drill guide to drill a pilot hole in the desired screw hole. Measure the depth of the hole with the depth gauge, select the 6.5mm screw with the corresponding length and insert it into the hole with the screwdriver (Figure 11). Place additional screws as needed. REGENEREX RINGLOC+ MODULAR ACETABULAR SYSTEM ORDERING INFORMATION – IMPLANTS REGENEREX™ RINGLOC®+ SOLID SHELL ACETABULAR COMPONENTS* Implant Image Implant Part # PT-104048 PT-104050 PT-104052 PT-104054 PT-104056 PT-104058 PT-104060 PT-104062 PT-104064 PT-104066 Implant Style Shell Gauge # Provisional # 31-400648 31-400650 31-400652 31-400654 31-400656 31-400658 31-400660 31-400662 31-400664 31-400666 31-177948 31-177950 31-177952 31-177954 31-177956 31-177958 31-177960 31-177962 31-177964 31-177966 Description REGENEREX/RNGL+ SOLID REGENEREX/RNGL+ SOLID REGENEREX/RNGL+ SOLID REGENEREX/RNGL+ SOLID REGENEREX/RNGL+ SOLID REGENEREX/RNGL+ SOLID REGENEREX/RNGL+ SOLID REGENEREX/RNGL+ SOLID REGENEREX/RNGL+ SOLID REGENEREX/RNGL+ SOLID Size 48MM SZ 22 50MM SZ 22 52MM SZ 23 54MM SZ 23 56MM SZ 24 58MM SZ 24 60MM SZ 25 62MM SZ 25 64MM SZ 26 66MM SZ 26 Please refer to the Biomet Price Guide for even sized 42–80mm implant style provisionals and shell gauge sizes 40–80mm. *One apical plug packaged with each solid shell. REGENEREX™ RINGLOC®+ LIMITED-HOLE ACETABULAR COMPONENTS Implant Image Implant Part # PT-116048 PT-116050 PT-116052 PT-116054 PT-116056 PT-116058 PT-116060 PT-116062 PT-116064 PT-116066 Implant Style Shell Gauge # Provisional # 31-400648 31-400650 31-400652 31-400654 31-400656 31-400658 31-400660 31-400662 31-400664 31-400666 31-177948 31-177950 31-177952 31-177954 31-177956 31-177958 31-177960 31-177962 31-177964 31-177966 Description REGENEREX/RNGL+ LTD REGENEREX/RNGL+ LTD REGENEREX/RNGL+ LTD REGENEREX/RNGL+ LTD REGENEREX/RNGL+ LTD REGENEREX/RNGL+ LTD REGENEREX/RNGL+ LTD REGENEREX/RNGL+ LTD REGENEREX/RNGL+ LTD REGENEREX/RNGL+ LTD Size 48MM SZ 22 50MM SZ 22 52MM SZ 23 54MM SZ 23 56MM SZ 24 58MM SZ 24 60MM SZ 25 62MM SZ 25 64MM SZ 26 66MM SZ 26 Please refer to the Biomet Price Guide for even sized 42–80mm implant style provisionals and shell gauge sizes 40–80mm. REGENEREX™ RINGLOC®+ MULTI-HOLE ACETABULAR COMPONENTS Implant Image Implant Part # PT-106054 PT-106056 PT-106058 PT-106060 PT-106062 PT-106064 PT-106066 PT-106068 PT-106070 PT-106072 Implant Style Shell Gauge # Provisional # 31-400654 31-400656 31-400658 31-400660 31-400662 31-400664 31-400666 31-400668 31-400670 31-400672 31-177954 31-177956 31-177958 31-177960 31-177962 31-177964 31-177966 31-177968 31-177970 31-177972 Please refer to the Biomet Price Guide for even sized 42–80mm implant style provisionals and shell gauge sizes 40–80mm. An Implant Style Provisional or Shell Gauge can be used for trialing. It is not necessary to use both. RingLoc® liner trials are also available. Please refer to the Biomet Price Guide for ordering information. Description REGENEREX/RNGL+ MULTI REGENEREX/RNGL+ MULTI REGENEREX/RNGL+ MULTI REGENEREX/RNGL+ MULTI REGENEREX/RNGL+ MULTI REGENEREX/RNGL+ MULTI REGENEREX/RNGL+ MULTI REGENEREX/RNGL+ MULTI REGENEREX/RNGL+ MULTI REGENEREX/RNGL+ MULTI Size 54MM SZ 23 56MM SZ 24 58MM SZ 24 60MM SZ 25 62MM SZ 25 64MM SZ 26 66MM SZ 26 68MM SZ 27 70MM SZ 27 72MM SZ 28 ORDERING INFORMATION – IMPLANTS, CONTINUED Image Part Number *One apical plug packaged with each solid shell. LINER SIZE GUIDE Regenerex™ RingLoc®+ Cup Size 42mm 44mm 46mm 48mm 50mm 52mm 54mm 56mm 58mm 60mm 62mm 64mm 66mm 68mm 70mm 72mm 74mm 76mm 78mm 80mm Liner Size 20 20 21 22 22 23 23 24 24 25 25 26 26 27 27 28 28 28 28 28 Description 123741 3/8–24 Apical Hole Plug* 106021 106022 106023 106024 106025 106026 106027 106028 RingLoc®+ Replacement Ring RingLoc®+ Replacement Ring RingLoc®+ Replacement Ring RingLoc®+ Replacement Ring RingLoc®+ Replacement Ring RingLoc®+ Replacement Ring RingLoc®+ Replacement Ring RingLoc®+ Replacement Ring Size – Size 21 Size 22 Size 23 Size 24 Size 25 Size 26 Size 27 Size 28 ORDERING INFORMATION – INSTRUMENTS Image Part Number Description 420048 420049 Straight Hex Ratchet Shaft Straight Hex Ratchet Shaft 424417 Screw Forceps 31-424200 Modular Ratchet Handle 31-424201 31-424202 31-111114 U-Joint Driver U-Joint Driver Flexible Depth Gauge Size 2.5mm 3.5mm – – 2.5mm 3.5mm – 31-424203 2-in-1 Drill Guide 2.8mm & 3.2mm 31-424205 Dual Angle Drill Guide 3.2mm 31-424204 RingLoc®+ Quick Connect Flexible Drill Shaft – 31-282815/80 31-323215/80 RingLoc + Quick Connect Drill Bits RingLoc®+ Quick Connect Drill Bits 2.8mm 3.2mm ® 31-111128 31-111132 31-111136 31-111138 31-111140 Liner Impactor Liner Impactor Liner Impactor Liner Impactor Liner Impactor 28mm 32mm 36mm 38mm 40mm 31-434547 Fixed Version Guide Lateral – S313135 Mag Hndl Adapter Multi Tool – 31-400600 MIH Cup Inserter Handle – Modular – 31-400602 MIH Cup Inserter Handle Tip – Spherical (3/8) – 31-400604 MIH RingLoc®+ Cup Inserter Handle – Square Tip (1/4) 31-400605 MIH Handle 1/4 Thread Insert – – ORDERING INFORMATION – INSTRUMENTS, CONTINUED Image Part Number Description Size S313141 Straight Magnum Inserter Handle S313142 S313144 Straight Mag Handle Threaded Rod Kit Straight Mag Handle Threaded Rod Kit S313145 Straight Mag Handle Tip – Spherical 31-478350 Universal Thread Extractor – 31-424206 31-424207 Liner Removal Tool Liner Removal Tool Inr sz 21–28 Inr sz 20 31-177901 Shell Gauge Handle – 31-400620 31-400621 31-400622 31-400623 31-400624 31-400625 31-400626 31-400627 31-400628 RingLoc®+ Impactor Plate RingLoc®+ Impactor Plate RingLoc®+ Impactor Plate RingLoc®+ Impactor Plate RingLoc®+ Impactor Plate RingLoc®+ Impactor Plate RingLoc®+ Impactor Plate RingLoc®+ Impactor Plate RingLoc®+ Impactor Plate Size 20 Size 21 Size 22 Size 23 Size 24 Size 25 Size 26 Size 27 Size 28 RingLoc® Instrument Case Shell (w/lid) – 595624 – Square tip – 1/4 Square tip – 3/8 – 595620 RingLoc® Insertion and Screw Instrument Case (w/lid) – 595621 RingLoc® Provisional and Reamer Inst Case (w/lid) – 595622 RingLoc® Liner and Head Trial Instrument Case (w/lid) – 595623 RingLoc® General Inst Case (w/lid) – 595627 RingLoc® Tag Set - General Instruments 595629 RingLoc® Tag Set - 28mm Liner Trials – 595630 RingLoc® Tag Set - 32mm Liner Trials – 595631 RingLoc® Tag Set - 36mm Liner Trials – 595632 RingLoc Tag Set - 38mm Liner Trials – 595633 RingLoc® Tag Set - 40mm Liner Trials – ® – Biomet Orthopedics, Inc. P.O. Box 587 01-50-0961 Date: 01/07 56 East Bell Drive Warsaw, Indiana 46581 USA Biomet® Hip Joint Replacement Prostheses ATTENTION OPERATING SURGEON 5. Prior to seating the liner into the shell component, all surgical debris (tissue fragments, etc.) must be removed from the interior of the shell component, as debris may inhibit the locking mechanism from engaging and securing the liner into the shell component. 6. Perforation entirely through the pelvic bone with dome fixation screws or rim screws is to be completely avoided. Caution is to be used when determining and selecting the length of screws to be used, as perforation through the pelvic bone with screws that are too long can cause damage to body structures (blood vessels, etc.) located on the interior side of the DESCRIPTION Biomet manufactures a variety of hip joint replacement prostheses. Hip joint replacement components include: femoral stems, femoral heads, acetabular pelvis. 7. Tight fixation of all non-cemented components at the time of surgery is critical to the success of the procedure. Each component must properly shells, and acetabular liners. Components are available in a variety of designs and size ranges intended for both primary and revision applications. Specialty press fit into the host bone which necessitates precise operative technique and the use of specified instruments. Bone stock of adequate components are available including: acetabular screws, centering sleeves, and canal plugs. Materials Femoral Stems CoCrMo Alloy or Titanium Alloy Femoral Heads Acetabular Shells Acetabular Liners CoCrMo Alloy Titanium Alloy Ultra-High Molecular Weight Polyethylene (UHMWPE) Acetabular Screws Centering Sleeves Titanium Alloy Polymethylmethacrylate (PMMA) Canal Plugs Porous Coating UHMWPE Titanium Alloy INDICATIONS 1. Noninflammatory degenerative joint disease including osteoarthritis and quality must be present and appraised at the time of surgery. 8. 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. 9. Acetabular shells should only be used with compatible FDA cleared acetabular liners. 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. avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 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 limitation of the 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using reconstruction and the need for protection of the implants from full load bearing until adequate fixation and healing have occurred. Excessive activity, trauma and other techniques. 5. Revision procedures where other treatment or devices have failed. weight gain 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 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, in- successful revision surgery more difficult. The patient is to be made aware and warned of general surgical risks, possible adverse effects as listed, and to follow cluding control of weight and activity level, 3) a good nutritional state of the patient, and 4) the patient must have reached full skeletal maturity. the instructions of the treating physician including follow-up visits. PRECAUTIONS CONTRAINDICATIONS Absolute contraindications include: infection, sepsis, and osteomyelitis. Specialized instruments are designed for Biomet® joint replacement systems to aid in the accurate implantation of the prosthetic components. The use of Relative contraindications include: 1) uncooperative patient or patient with neurologic disorders who are incapable of following directions, 2) osteoporosis, 3) instruments or implant components from other systems can result in inaccurate fit, sizing, excessive wear and device failure. Intraoperative fracture or breaking of instruments has been reported. Surgical instruments are subject to wear with 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, normal usage. Instruments, which have experienced extensive use or excessive force, are susceptible to fracture. Surgical instruments should only be used for marked bone loss or bone resorption apparent on roentgenogram, and 7) vascular insufficiency, muscular atrophy, or neuromuscular disease. their intended purpose. Biomet recommends that all instruments be regularly inspected for wear and disfigurement. WARNINGS Improper selection, placement, positioning, alignment and fixation of the implant 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. 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/ Do not treat patients with implants that have been, even momentarily, placed in a different patient. or failure of the implant or procedure. Inadequate preclosure cleaning (removal of surgical debris) can lead to excessive wear. Improper preoperative or POSSIBLE ADVERSE EFFECTS 1. Material sensitivity reactions. Implantation of foreign material in tissues 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 instru- can result in histological reactions involving various sizes of macrophages and fibroblasts. The clinical significance of this effect is uncertain, as similar changes may occur as a precursor to or during the healing process. ments, prior to performing surgery. Particulate wear debris and discoloration from metallic and polyethylene components of joint implants may be present in adjacent tissue or fluid. It 1. Use Biomet® femoral and modular head component with appropriate matching “Type I Taper”, “Type II Taper”, or “12/14 Taper”. 2. Firmly seat modular head components to prevent dissociation. Thoroughly clean and dry taper prior to attachment of the modular head component to avoid crevice corrosion and improper seating. 3. Acetabular screws are to be fully seated to assure stable fixation and to avoid interference with the acetabular liner component. 4. In any instance where a liner engages the RingLoc® locking ring and the liner is subsequently removed or replaced, the RingLoc® locking ring should be replaced with a new ring. 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. Further, there has been a report regarding an association between articulating surfaces of: 1) CoCrMo alloy on CoCrMo alloy, 2) CoCrMo alloy on polyethylene, and 3) Titanium alloy on polyethylene in hip replacements and increased genotoxicity. This report, however, did not assess either the clinical relevance of the data or make any definite conclusions as to which metal ions or interactions between metal ions or particulate metals might be responsible for the observed data. The report further cautioned that an association does not necessarily mean a causal relationship, and that any potentially increased risk associated with metal ions needs to be balanced against the benefits resulting from hip replacement. 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. 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 fixation, trauma, malalignment, bone resorption, or excessive activity. 5. Periarticular calcification or ossification, 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 fixation and improper positioning. Muscle and fibrous tissue laxity can also contribute to these conditions. 9. Fatigue fracture of component can occur as a result of loss of fixation, 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. Trochanteric avulsion or non-union as a result of excess muscular tension, early weight bearing, or inadequate reattachment. 13. Problems of the knee or ankle of the affected limb or contralateral limb aggravated by leg length discrepancy, too much femoral medialization or muscle deficiencies. 14. Postoperative bone fracture and pain.