Optetrak 230-03-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10885862061744), received between Feb 12, 2020 and Jul 1, 2025 — classified as 14 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2025Naturally Worn; Naturally Worn

  INFORMED TO EXCHANGE INSERT BY HOSPITAL, AFTER ABOUT 7 YEARS LATER FROM A PRIMARY SURGERY. THE PATIENT WHO HAD TOTAL KNEE ARTHROPLASTY USING CR SLOPE ++ TIBIAL INSERT COMPLAINED KNEE SWELLING AND PAIN, THE SURGEON DIAGNOSED THE WEAR OF THE TIBIAL INSERT, THEN REVISION SURGERY FOR THE REPLACEMENT OF THE TIBIAL INSERT WAS PERFORMED. BREAKAGE AND WEAR WAS OBSERVED IN THE RETRIEVED TIBIAL INSERT. ALSO, HE FOUND OUT METALLOSIS. HE DECIDED THAT NO PROBLEM OF LOCKING MECHANISM OF THE TIBIAL TRAY WAS FOUND, AND REMOVING ALL PROLIFERATIVE TISSUES, THE INSERT ONLY WAS REPLACED TO NEW ONE.

  Patient problems: Metal Related Pathology; Pain; Swelling/ Edema

  MAUDE report 22374771 ↗
• InjuryJan 13, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 123 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT AN ARTHROSCOPY PROCEDURE DUE TO SYNOVITIS AND LOOSENING. PATIENT BEGAN EXPERIENCING PAIN, POPPING, CLICKING AND CATCHING OF THE RIGHT KNEE AFTER A FALL APPROXIMATELY 7 MONTHS PRIOR. ARTHROSCOPIC SURGERY OPERATIVE NOTES WERE PROVIDED. POSTOPERATIVE DIAGNOSIS INDICATED SYNOVITIS, TIBIAL COMPONENT LOOSENING, METALLOSIS, AND FRACTURED TIBIAL POLYETHYLENE WITH LOOSE FRAGMENTS. SURGEON PERFORMED A THREE COMPARTMENT SYNOVECTOMY AND LOOSE BODY REMOVAL FROM WITHIN THE NOTCH. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. NO INTRAOPERATIVE OR POSTOPERATIVE COMPLICATIONS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Metal Related Pathology; Pain; Peeling; Synovitis

  MAUDE report 21143945 ↗
• InjuryOct 25, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE-USA. PATIENT ID: (B)(6). IT WAS REPORTED THAT APPROXIMATELY 136 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SCAR TISSUE AND SYNOVITIS. OP REPORT NOTED POLY HAD SEVERE WEAR PATTERN AND PULSED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. SERIAL NUMBER, ITEM NUMBER AND FULL DESCRIPTION (B)(6), 200-72-09 - CR TIBIAL INSERT SZ 2, 9MM, SLOPE ++ SERIAL NUMBER: (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510(K): K082022. CONCOMITANTS: 2155075 200-05-26 - INSET PATELLA 26MM, 2281536 230-03-02 - OPTETRAK ASY, CR CEMENTED FEMORAL, SZ 2, 2311025 200-04-22 - CEMENTED FINNED TIB. TRA SZ 2F/2T.

  Patient problems: Scar Tissue; Synovitis

  MAUDE report 20536452 ↗
• InjuryOct 7, 2024Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 135 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, POLYETHYLENE WEAR, OSTEOLYSIS, AND ASEPTIC LOOSENING. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity; Metal Related Pathology; Osteolysis; Pain; Synovitis

  MAUDE report 20383118 ↗
• InjuryOct 4, 2024Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  LEGAL CASE - USA: PATIENT ID: (B)(6). ON 10/3/2024: ADDITIONAL INFORMATION RECEIVED IN IN-BOX ON 10/2/2024. ARTHROSCOPY OP REPORT, AND REVISION OP REPORT. THE PATIENT HAD A FALL IN (B)(6) OF 2022. SHE WAS WALKING UP SOME STEPS, LANDED ON THE ANTERIOR ASPECT OF HER KNEE, AND STARTED NOTICING CLICKING, POPPING, CATCHING, AND PAIN WITHIN HER KNEE. PRIOR TO THAT, SHE REALLY DID NOT HAVE ANY MAJOR SYMPTOMS. ATTACHED EXPLORATORY ARTHROSCOPY OP REPORT FROM (B)(6) OF 2023 DISCOVERED SYNOVITIS, TIBIAL COMPONENT LOOSENING, METALLOSIS, AND LOOSE AND FRACTURED LATERAL TIBIAL POLYETHYLENE. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED FOR PROCEDURE IN (B)(6) OF 2023. PREOPERATIVE AND POSTOPERATIVE DIAGNOSES INDICATED FAILED RIGHT TOTAL KNEE ARTHROPLASTY DUE TO SEVERE POLYETHYLENE WEAR DISEASE AND OSTEOLYSIS. DESCRIPTION OF PROCEDURE: UPON ENTERING THE JOINT I FOUND THE SYNOVIAL LINING OF THE JOINT WAS BLACK DUE TO METALLOSIS. INSPECTION OF THE COMPONENTS FOUND THAT THE POSTERIOR ASPECT OF THE POLY INSERT WAS COMPLETELY WORN OUT AND A LARGE PORTION OF THE POSTERIOR LATERAL TIBIAL PLATE WAS ERODED AWAY. THE PREVIOUS LINER WAS DISLODGED FROM THE TIBIAL COMPONENT. I THEN INSPECTED THE FEMORAL AND

  Patient problems: Implant Pain; Joint Laxity; Metal Related Pathology; Osteolysis; Synovitis

  MAUDE report 20369842 ↗
• InjurySep 27, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 10 MONTHS POST THE PREVIOUS REVISION SURGERY, THE PATIENT HAD KNEE PAIN AND THE SURGEON DECIDED TO REVISE AGAIN BECAUSE THE FEMORAL AND TIBIAL COMPONENTS HAD BEEN FOUND TO BE LOOSE. METALLOSIS WAS FOUND AND ALL PROLIFERATIVE TISSUE REMOVED, THEN ALL COMPONENTS WERE REPLACED TO COMPETITOR DEVICES. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Implant Pain; Metal Related Pathology; Osteolysis; Pain

  MAUDE report 20320362 ↗
• InjuryJun 11, 2024Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 143 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE ADDRESS PAIN, SWELLING AND INSTABILITY DUE TO ASEPTIC LOOSENING, OSTEOLYSIS AND FAILURE OF THE POLYETHYLENE LINER. A REVISION OPERATIVE REPORT WAS PROVIDED. INTRAOPERATIVELY, THE SURGEON OBSERVED BLACK STAINED TISSUE, AND THE POLYETHYLENE WAS NOTED TO BE COMPLETELY ERODED THROUGH AND HAD SEPARATED FROM THE TIBIAL BASE PLATE. THE BLACKENED TAR TISSUE DUE TO THE METAL-ON-METAL ARTICULATION AFTER THE POLYETHYLENE FAILURE WAS REMOVED. THE FEMORAL AND TIBIAL COMPONENTS WERE REMOVED, AND IT WAS NOTED THAT THERE WAS A CENTRAL AREA OF BONE LOSS IN THE TIBIA AND A FAIRLY LARGE MEDIAL FEMORAL CONDYLE BONE LOSS AS WELL AS CENTRAL BONE LOSS IN THE FEMUR. NO MEDICAL OR SURGICAL INTERVENTION WAS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Implant Pain; Joint Laxity; Metal Related Pathology; Osteolysis; Swelling/ Edema

  MAUDE report 19515256 ↗
• InjuryJan 4, 2024Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2008. THIS DEVICE HAS NOT BEEN EXPLANTED. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A COORDINATED ACTION IN (B)(6) WITH MASTER CASE NO. (B)(4). THE CONSOLIDATED LONG FORM COMPLAINT THAT APPLIES TO CASES FILED IN THIS COORDINATED ACTION ALLEGES THAT PATIENTS FILING SUITS IN THIS COORDINATED ACTION WERE REQUIRED ¿TO UNDERGO REVISION SURGERIES DUE TO SEVERE, PAIN, SWELLING, AND INSTABILITY¿ DUE TO ¿WEAR OF THE POLYETHYLENE COMPONENTS AND RESULTING COMPONENT LOOSENING AND/OR OTHER FAILURE FAILURES CAUSING SERIOUS COMPLICATIONS INCLUDING TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES.¿ BECAUSE THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN THIS COORDINATED ACTION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF WEAR OF AN EXACTECH POLYETHYLENE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 18443892 ↗
• InjuryFeb 14, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR), THIS (B)(6) Y/O (BMI=41), FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE RIGHT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2012. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. THE PATIENT WAS IMPLANTED WITH A CRUCIATE RETAINING CEMENTED FEMORAL ASYMMETRICAL COMPONENTS (SIZE 2 RIGHT) (CATALOG 230-03-02, SERIAL (B)(4), OPTETRAK KNEE SYSTEM - CEMENTED FINNED TIBIAL TRAY - SIZES 1F/2T 2F/2T (CATALOG 200-04-22, SERIAL (B)(4), OPTETRAK KNEE SYSTEM - CRUCIATE RETAINED (CR) TIBIAL INSERT - SIZE 2 - 9MM (CATALOG 200-22-09, SERIAL (B)(4), OPTETRAK KNEE SYSTEM - THREE PEGS PATELLA - DIAMETER 29MM (CATALOG 200-02-29, SERIAL (B)(4) AND HERAEUS MEDICAL ANTIBIOTIC LOADED HIGH VISCOSITY BONE CEMENT (CATALOG 66017569, SERIAL (B)(4). ON (B)(6) 2017, APPROXIMATELY 60 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING FEMUR; ASEPTIC LOOSENING TIBIA. THE EXACTECH KNEE BRAND REMOVED UNAVAILABLE AND REPLACED WITH SIGMA FEMORAL PS NON-LUGGED CEMENTED SIZE 2.5 RIGHT, PFC OFFSET TIBIAL TRAY SIZE 2.5 RM/LL AND SIGMA STABILISED GVF INSERT SIZE 2.5 10MM.

  Patient problems: Failure of Implant

  MAUDE report 9715033 ↗
• InjuryFeb 14, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR), THIS (B)(6) Y/O (BMI=35), FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE RIGHT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2012. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. THE PATIENT WAS IMPLANTED WITH A CRUCIATE RETAINING CEMENTED FEMORAL ASYMMETRICAL COMPONENTS (SIZE 2 RIGHT) (CATALOG 230-03-02, SERIAL (B)(4), OPTETRAK KNEE SYSTEM - CEMENTED FINNED TIBIAL TRAY - SIZES 1F/2T 2F/2T (CATALOG 200-04-22, SERIAL (B)(4), OPTETRAK KNEE SYSTEM - CRUCIATE RETAINED (CR) TIBIAL INSERT - SIZE 2 - 9MM (CATALOG 200-22-09, SERIAL (B)(4) AND STRYKER ANTIBIOTIC LOADED MEDIUM VISCOSITY BONE CEMENT (CATALOG 61969001, SERIAL (B)(4). ON (B)(6) 2014, APPROXIMATELY 21 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING FEMUR; ASEPTIC LOOSENING TIBIA; PAIN; STIFFNESS. THE EXACTECH WERE REMOVED AND REPLACED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 9714974 ↗
• InjuryFeb 14, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY (B)(6), THIS (B)(6), FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE RIGHT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2008. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. THE PATIENT WAS IMPLANTED WITH A CRUCIATE RETAINING CEMENTED FEMORAL ASYMMETRICAL COMPONENTS (SIZE 2 RIGHT) (CATALOG 230-03-02, SERIAL (B)(4)), OPTETRAK KNEE SYSTEM - CEMENTED FINNED TIBIAL TRAY - SIZES 1F/2T 2F/2T (CATALOG 200-04-22, SERIAL (B)(4)), OPTETRAK KNEE SYSTEM - CRUCIATE RETAINED (CR) TIBIAL INSERT - SIZE 2 - 9MM (CATALOG 200-22-09, SERIAL (B)(4)), OPTETRAK KNEE SYSTEM - THREE PEGS PATELLA - DIAMETER 35MM (CATALOG 200-02-35, SERIAL (B)(4)) AND HERAEUS MEDICAL ANTIBIOTIC LOADED HIGH VISCOSITY BONE CEMENT (CATALOG 66017569, SERIAL (B)(4)). ON (B)(6) 2009, APPROXIMATELY 11 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING TIBIA. THE EXACTECH KNEE BRAND REMOVED UNAVAILABLE AND REPLACED WITH STEMMED CEMENTED PRECOAT TIBIAL PLATE SIZE 3 AND LPS FLEX/FIX C/D 3-4 14MM.

  Patient problems: Failure of Implant

  MAUDE report 9714664 ↗
• InjuryFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY (B)(6), THIS (B)(6), FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE RIGHT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2010. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. THE PATIENT WAS IMPLANTED WITH A CRUCIATE RETAINING CEMENTED FEMORAL ASYMMETRICAL COMPONENTS (SIZE 2 RIGHT) (CATALOG 230-03-02, SERIAL (B)(4)), OPTETRAK KNEE SYSTEM - CEMENTED FINNED TIBIAL TRAY - SIZES 1F/2T 2F/2T (CATALOG 200-04-22, SERIAL (B)(4)), OPTETRAK KNEE SYSTEM - CRUCIATE RETAINED (CR) TIBIAL INSERT - SIZE 2 - 11MM (CATALOG 200-22-11, SERIAL (B)(4)) AND HERAEUS MEDICAL ANTIBIOTIC LOADED HIGH VISCOSITY BONE CEMENT (CATALOG 66017569, SERIAL (B)(4)). ON (B)(6) 2016, APPROXIMATELY 71 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING FEMUR; ASEPTIC LOOSENING TIBIA; INSTABILITY. THE EXACTECH KNEE BRAND REMOVED UNAVAILABLE AND REPLACED WITH SIGMA FEMORAL PS NON-LUGGED CEMENTED SIZE 2 RIGHT, MBT REVISION TIBIAL TRAY CEMENTED SIZE 2 AND ROTATING PLATFORM STABILISED TIBIAL INSERT SIZE 2 12.5MM, .

  Patient problems: Failure of Implant

  MAUDE report 9713687 ↗
• InjuryFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY (B)(6), THIS (B)(6), FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE RIGHT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2010. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2012, APPROXIMATELY 17 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO TIBIAL OSTEOLYSIS (¿LYSISTIBIA¿). FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT BE PERFORMED FOR THIS COMPLAINT, INFORMATION WAS SUBMITTED AS COMPLETE BY (B)(6); THERE IS NO IDENTIFICATION OF FACILITIES OR SURGEONS. ALL AVAILABLE INFORMATION ABOUT THE EVENT AND/OR PATIENT HAS BEEN PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DEVICE DESIGN OR MANUFACTURING ISSUES. THE EVENT REPORTED WAS LIKELY THE RESULT OF PATIENT CONDITIONS. THERE HAS BEEN NO PATIENT MEDICAL HISTORY/INFORMATION PROVIDED; THEREFORE, THE PATIENT RISK/CLINICAL FACTORS CANNOT BE ASSESSED.

  Patient problems: Osteolysis

  MAUDE report 9712894 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR), THIS (B)(6) Y/O, 148 CM, (B)(6) KG(BMI=34), FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE RIGHT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2014. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2019, APPROXIMATELY 57 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO INSTABILITY. FOLLOW-UPS FOR ADDITIONAL INFORMATION WILL NOT BE PERFORMED FOR THIS COMPLAINT, INFORMATION WAS SUBMITTED AS COMPLETE BY THE UNITED KINGDOM NATIONAL JOINT REGISTRY (UKNJR); THERE IS NO IDENTIFICATION OF FACILITIES OR SURGEONS. ALL AVAILABLE INFORMATION ABOUT THE EVENT OR PATIENT HAS BEEN PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE KNEE INSTABILITY REPORTED WAS LIKELY THE RESULT OF PATIENT CONDITIONS. THE PATIENT HAS A HIGH BMI WHICH INDICATES THAT THEY ARE OVERWEIGHT. OVERWEIGHT PATIENTS INCREASE BIOMECHANICAL STRESSORS ON NATURAL AND ARTIFICIAL JOINTS.

  Patient problems: Failure of Implant

  MAUDE report 9703607 ↗