Optetrak 232-02-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862063021), received between Jul 7, 2025 and Jul 7, 2025 — 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.

• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 7 YEARS AND 4 MONTHS POST THE INITIAL LEFT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO DISTAL FEMORAL PERIPROSTHETIC FRACTURE SECONDARY TO EXTENSIVE OSTEOLYSIS ASSOCIATED WITH PREMATURE POLYETHYLENE WEAR. THE PATIENT WAS REVISED TO COMPETITOR DEVICES. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT IS DOING WELL AND IN STABLE CONDITION. NO FURTHER INFORMATION REPORTED.

  Patient problems: Bone Fracture(s); Osteolysis

  MAUDE report 22410920 ↗