Optetrak 232-02-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862063038), received between Nov 4, 2020 and Jan 28, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT APPROXIMATELY 101 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, METALLOSIS, PAIN, JOINT LAXITY, JOINT INSTABILITY, OSTEOLYSIS ON THE MEDIAL FEMORAL CONDYLE, AND TIBIAL BONE LOSS. 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." X-RAY: NO. OPERATIVE NOTES: YES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Metal Related Pathology; Osteolysis; Pain; Scar Tissue

  MAUDE report 21252537 ↗
• InjuryNov 4, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 5 YEARS POST-OP THE INITIAL KNEE IMPLANT, A MALE PATIENT, AGE AND WEIGHT UNKNOWN, ALLEGES THAT HIS IMPLANTED DEVICE FAILED AND CAUSED HIM BODILY INJURY, SOME OF WHICH MAY BE PERMANENT IN NATURE, SUFFERED PAIN, EMOTIONAL DISTRESS, AND REQUIRED ADDITIONAL SURGICAL PROCEDURES TO REMOVE THE DEFECTIVE DEVICE. IT IS UNKNOWN IF THE PATIENT HAD ALL DEVICES REMOVED OR IF EXACTECH DEVICES WERE THE REVISION DEVICES. NO OTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 10786885 ↗