Optetrak 230-03-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862061775), received between Feb 12, 2020 and Sep 19, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA LEGAL DOCUMENTATION 8 YEARS AND 6 MONTHS AFTER A RIGHT TOTAL KNEE ARTHROPLASTY A PATIENT DEVELOPED WORSENING RIGHT KNEE PAIN AND SWELLING AND WAS SURGICALLY REVISED. OPERATIVE NOTES INDICATE NEGATIVE FOR ACUTE INFLAMMATION AND EVIDENCE OF CHRONIC INFLAMMATION INTRAOPERATIVE FINDINGS INCLUDE POLYETHYLENE WEAR WITH OSTEOLYSIS AND LOOSE FEMORAL, TIBIAL AND PATELLAR BUTTON, AS WELL AS FEMORAL CONDYLE BONE LOSS. THERE WERE NO COMPLICATIONS WITH REVISION AND PATIENT WAS TRANSFERRED TO PACU IN STABLE CONDITION THERE IS NO OTHER INFORMATION AVAILABLE. NO IMAGES WERE PROVIDED.

  Patient problems: Implant Pain; Inflammation; Joint effusion; Osteolysis; Unspecified Infection

  MAUDE report 20258077 ↗
• InjuryFeb 14, 2020Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth; Naturally Worn; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY (B)(6), THIS (B)(6) Y/O, 180 CM, (B)(6) (BMI=28), MALE 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 OPTETRAK AYSMETRIC FEMOR (RIGHT SIZE 5) (CATALOG 230-03-05, SERIAL (B)(4)), OPTETRAK KNEE SYSTEM - CEMENTED FINNED TIBIAL TRAY - SIZE 5F/4T(CATALOG 200-04-54, SERIAL (B)(4)), OPTETRAK KNEE SYSTEM - CRUCIATE RETAINED (CR) TIBIAL INSERT - SIZE 5 - 9MM (CATALOG 200-25-09, SERIAL (B)(4)) AND HERAEUS MEDICAL ANTIBIOTIC LOADED HIGH VISCOSITY BONE CEMENT (CATALOG 66017569, SERIAL (B)(4)). ON (B)(6) 2016, APPROXIMATELY 64 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO ASEPTIC LOOSENING FEMUR; ASEPTIC LOOSENING TIBIA; WEAR OF POLYETHYLENE COMPONENT. THE EXACTECH KNEE BRAND REMOVED UNAVAILABLE AND REPLACED WITH SIGMA FEMORAL PS NON-LUGGED CEMENTED SIZE 5 RIGHT, MBT CEMENTED KEEL TIB TRAY SZ5, ROTATING PLATFORM STABILISED TIBIAL INSERT SIZE 5 12.5MM AND PFC« SIGMA OVAL PATELLA 41MM.

  Patient problems: Failure of Implant

  MAUDE report 9714766 ↗
• InjuryFeb 14, 2020Insufficient Device Problem Information

  AS REPORTED BY (B)(6), THIS (B)(6) Y/O, MALE 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. ON (B)(6) 2014, APPROXIMATELY 14 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO OTHER INDICATION FOR REVISION. 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/INFORMATION PROVIDED; THEREFORE, THE PATIENT RISK/CLINICAL FACTORS CANNOT BE ASSESSED.

  Patient problems: No Code Available

  MAUDE report 9712721 ↗
• InjuryFeb 12, 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, MALE 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. ON (B)(6) 2014, APPROXIMATELY 23 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO PAIN. THE UNDERLYING CAUSE FOR PAIN WAS NOT REPORTED. 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 INFORMATION PROVIDED; THEREFORE, THE PATIENT RISK/CLINICAL FACTORS CANNOT BE ASSESSED.

  Patient problems: Pain

  MAUDE report 9701552 ↗
• 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, MALE 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) 2019, APPROXIMATELY 91 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT REVISION DUE TO INFECTION. 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. 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: Bacterial Infection

  MAUDE report 9699777 ↗
• InjuryFeb 12, 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, 168 CM, (B)(6) (BMI=30), MALE 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 32 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 P

  Patient problems: Failure of Implant

  MAUDE report 9699340 ↗