Optetrak 232-03-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862063113), received between Oct 1, 2020 and Oct 1, 2020 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 7 YEARS POSTOP THE INITIAL RIGHT TKA, THIS (B)(6) Y/O MALE PATIENT EXPERIENCED SEVERE INSTABILITY THROUGH RANGE OF MOTION. DURING THE OPERATION THERE WAS NOTICEABLE OSTEOLYSIS PRESENT, BACTERIAL SWABS AND TISSUE SAMPLES WERE COLLECTED AND SENT TO PATHOLOGY. NOTICEABLE DISTAL AND POSTERIOR BONE LOSS WAS SEEN ON THE LATERAL SIDE OF THE FEMUR. PATIENTS OWN BONE, BONE CEMENT AND AUGMENTS WERE USED TO REPAIR FEMORAL DEFECTS. THE POLYETHYLENE INSERT WAS DESTROYED ESPECIALLY ON THE POSTERIOR- LATERAL SIDE. DEVICES ARE TO RETURN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant

  MAUDE report 10612764 ↗