Optetrak 230-03-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885862061751), received between Feb 12, 2020 and Aug 18, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED STIFFNESS, PAIN, OSTEOLYSIS, FEMORAL AND TIBIAL IMPLANT LOOSENING, AND DISSATISFACTION WITH THEIR TOTAL KNEE REPLACEMENT. AS A RESULT, APPROXIMATELY TEN YEARS AND ONE-MONTH POST-SURGERY, THE PATIENT UNDERWENT A REVISION. PATIENT WAS REVISED TO COMPETITOR'S DEVICES. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. THE PRODUCTS ARE NOT AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 2 OF 3 FOR THIS EVENT/PATIENT.

  Patient problems: Osteolysis; Pain

  MAUDE report 22829353 ↗
• InjuryJan 30, 2025Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT. APPROXIMATELY 55 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT KNEE REVISION DUE TO THE POLYETHYLENE LINER WEAR WITH RESULTING OSTEOLYSIS AND ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS. THE LOOSENING MAY HAVE BEEN THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE IMPLANTS AND THE BONES. THE EXTENT OF THE REPORTED POLYETHYLENE WEAR CANNOT BE DETERMINED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES OF THE EXPLANTED DEVICES, PRE-REVISION RADIOGRAPHS, AND OPERATIVE NOTES WERE NOT PROVIDED. IT WAS ADDITIONALLY NOTED THAT DESPITE UNDERGOING REVISION SURGERY THE PATIENT EXPERIENCES DAILY KNEE PAIN AND DISCOMFORT WHICH LIMITS THE PATIENT'S ACTIVITIES OF DAILY LIVING AND RECREATION AND IMPACTS THE PATIENT'S QUALITY OF LIFE. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Implant Pain; Joint Laxity; Metal Related Pathology; Osteolysis; Scar Tissue

  MAUDE report 21273365 ↗
• InjuryDec 31, 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 120 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS LOOSENING, AMBULATION DIFFICULTIES, BALANCE PROBLEMS, DISCOMFORT, PAIN, JOINT LAXITY, OSTEOLYSIS, SWELLING AND EDEMA.. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; Implant Pain; Joint Laxity; Metal Related Pathology; Osteolysis; Swelling/ Edema

  MAUDE report 21047267 ↗
• InjuryDec 9, 2024Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 61 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS SECONDARY TO SIGNIFICANT POLYETHYLENE LINER WEAR WITH RESULTING METALLOSIS, OSTEOLYSIS, AND SYNOVITIS, DAILY KNEE PAIN AND DISCOMFORT WHICH LIMIT ACTIVITIES OF DAILY LIVING AND RECREATION AND IMPACTS QUALITY OF LIFE. THERE IS NO DEVICE RETURN. . INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR AND LOOSENING OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Discomfort; High metal ion levels; Metal Related Pathology; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 20880773 ↗
• InjuryMar 29, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED VIA LEGAL DOCUMENTS THAT ON (B)(6), 2011 A FEMALE PATIENT UNDERWENT AN INITIAL RIGHT KNEE TOTAL ARTHROPLASTY, THEN ON (B)(6), 2012, THE PATIENT UNDERWENT A REVISION OF THE EXACTECH CONSTRAINED CONDYLAR FEMORAL COMPONENT APPROXIMATELY 1 YEAR 5 MONTHS AFTER IMPLANT. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16637156 ↗
• 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) Y/O, FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE RIGHT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2013. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. THE PATIENT WAS IMPLANTED WITH A ASYMMETRIC FEMORAL CRUCIATE RETAINED CEMENTED SIZE 3 RIGHT (CATALOG 230-03-03, SERIAL (B)(4)), OPTETRAK KNEE SYSTEM - CEMENTED FINNED TIBIAL TRAY - SIZE 3F/3T (CATALOG 200-04-33, SERIAL (B)(4)), OPTETRAK - CR INSERT - SIZE 3 9MM SLOPE + (CATALOG 200-63-09, SERIAL (B)(4)) AND STRYKER ANTIBIOTIC LOADED MEDIUM VISCOSITY BONE CEMENT (CATALOG 61971001, SERIAL(B)(4)). ON (B)(6) 2013, APPROXIMATELY 3 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING FEMUR. THE EXACTECH KNEE BRAND REMOVED UNAVAILABLE AND REPLACED WITH SIGMA FEMORAL POSTERIOR STABILIZED CEMENTED SIZE 3 RIGHT.

  Patient problems: Failure of Implant

  MAUDE report 9715034 ↗
• 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) Y/O, FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE RIGHT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2011. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. THE PATIENT WAS IMPLANTED WITH A ASYMMETRIC FEMORAL CRUCIATE RETAINED CEMENTED SIZE 3 RIGHT (CATALOG 230-03-03, SERIAL (B)(4)), OPTETRAK KNEE SYSTEM - CEMENTED FINNED TIBIAL TRAY - SIZE 3F/3T (CATALOG 200-04-33, SERIAL (B)(4)), OPTETRAK KNEE SYSTEM - CRUCIATE RETAINED (CR) TIBIAL INSERT - SIZE 3 - 13MM (CATALOG 200-23-13, SERIAL (B)(4)) AND HERAEUS MEDICAL ANTIBIOTIC LOADED HIGH VISCOSITY BONE CEMENT (CATALOG 66017569, SERIAL (B)(4)). ON (B)(6) 2019, APPROXIMATELY 105 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING FEMUR; ASEPTIC LOOSENING TIBIA. THE EXACTECH FEMORAL COMPONENT REMOVED; TIBIAL COMPONENT REMOVED; TIBIAL LINER COMPONENT REMOVED AND REPLACED WITH SIGMA FEMORAL POSTERIOR STABILIZED CEMENTED SIZE 3 RIGHT, MBT REVISION TIBIAL TRAY CEMENTED SIZE 3 AND ROTATING PLATFORM STABILISED TIBIAL INSERT SIZE 3 15.0MM.

  Patient problems: Failure of Implant

  MAUDE report 9714746 ↗
• 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) 2010. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. THE PATIENT WAS IMPLANTED WITH A ASYMMETRIC FEMORAL CRUCIATE RETAINED CEMENTED SIZE 3 RIGHT (CATALOG 230-03-03, SERIAL (B)(4)), OPTETRAK KNEE SYSTEM - CEMENTED FINNED TIBIAL TRAY - SIZE 3F/2T (CATALOG 200-04-32, SERIAL (B)(4)), OPTETRAK KNEE SYSTEM - CRUCIATE RETAINED (CR) TIBIAL INSERT - SIZE 3 - 11MM (CATALOG 200-23-11, SERIAL (B)(4)) AND HERAEUS MEDICAL ANTIBIOTIC LOADED HIGH VISCOSITY BONE CEMENT (CATALOG 66017569, SERIAL (B)(4)). ON (B)(6) 2015, APPROXIMATELY 53 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING TIBIA. THE EXACTECH KNEE BRAND REMOVED UNAVAILABLE AND REPLACED WITH MBT REVISION TIBIAL TRAY CEMENTED SIZE 2.5 AND ROTATING PLATFORM STABILISED TIBIAL INSERT SIZE 3 17.5MM.

  Patient problems: Failure of Implant

  MAUDE report 9714653 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY (B)(6), THIS (B)(6) Y/O, FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE RIGHT KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2011. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2014, APPROXIMATELY 35 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO INSTABILITY AND PATIENT CONDITION (MALALIGNMENT). MALALIGNMENT WAS NOT DEFINED IN THE REPORTED COMPLAINT INFORMATION, [THIS COULD MEAN THAT THE PATIENT CAUSED IMPLANTS TO BE OUT OF ALIGNMENT OR THAT THE SURGICAL PROCEDURE DID; THIS IS WILL BE INVESTIGATED AS ¿PATIENT CONDITION¿]. THE FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT BE PERFORMED FOR THIS COMPLAINT, INFORMATION WAS SUBMITTED AS COMPLETE BY THE (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

  Patient problems: Failure of Implant

  MAUDE report 9709974 ↗
• 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), A (B)(6) Y/O, FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT OF THE RIGHT KNEE ON (B)(6) 2011. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. ON (B)(6) 2013, APPROXIMATELY 12 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO INSTABILITY AND STIFFNESS. FOLLOW-UPS FOR ADDITIONAL INFORMATION CANNOT 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 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: Failure of Implant

  MAUDE report 9703600 ↗
• 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, FEMALE PATIENT UNDERWENT PRIMARY TOTAL PROSTHETIC REPLACEMENT USING CEMENT OF THE R KNEE VIA MEDIAL PARAPATELLAR APPROACH ON (B)(6) 2010. THE INDICATION FOR THE INDEX PROCEDURE WAS OSTEOARTHRITIS. THE PATIENT WAS IMPLANTED WITH A ASYMMETRIC FEMORAL CRUCIATE RETAINED CEMENTED SIZE 3 RIGHT (CATALOG 230-03-03, SERIAL (B)(4)), OPTETRAK KNEE SYSTEM - CEMENTED FINNED TIBIAL TRAY - SIZE 3F/2T (CATALOG 200-04-32, SERIAL (B)(4)), OPTETRAK KNEE SYSTEM - CRUCIATE RETAINED (CR) TIBIAL INSERT - SIZE 3 - 9MM (CATALOG 200-23-09, SERIAL (B)(4)), AND HERAEUS MEDICAL ANTIBIOTIC LOADED HIGH VISCOSITY BONE CEMENT (CATALOG 66017569, SERIAL (B)(4)). ON (B)(6) 2014, APPROXIMATELY 53 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO INFECTION. THE EXACTECH KNEE BRAND WERE REMOVED UNAVAILABLE AND REPLACED,

  Patient problems: Bacterial Infection

  MAUDE report 9699626 ↗