Biomet® Knee System 141658Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304003941), received between Jan 31, 2022 and Jan 31, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 31, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 2.5 YEARS POST IMPLANTATION DUE TO PAIN, LOOSENING, METAL DEBRIS, AND LIMITED MOBILITY. DURING THE REVISION, BLACKENED SYNOVIUM WITH METAL DEBRIS WAS NOTED. THE FEMUR, TIBIA, TIBIA ADAPTER, STEMS, AND BEARING WERE EXCHANGED WITHOUT COMPLICATIONS. THE PATELLA REMAINED INTACT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Local Reaction; Metal Related Pathology; Pain

  MAUDE report 13400593 ↗