Optetrak 204-46-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862049391), received between Apr 21, 2022 and Apr 21, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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 18, 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.

• InjuryApr 21, 2022Fracture; Fracture

  AS REPORTED, APPROXIMATELY 13.5 YEARS POST TKA, THIS 80 Y/O MALE PATIENT EXPERIENCED INCREASING PAIN AND LEFT LEG NO LONGER ABLE TO BEAR WEIGHT. RADIOLOGICALLY SHOWED PERIPROSTHETIC FRACTURE WITH FRACTURE OF THE FEMORAL STEM AT THE ADAPTER/STEM TRANSITION. PATIENT HAD A REVISION AND THE EXPLANT WAS PRESERVED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 14173613 ↗