NA 5842-23-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024633643), received between Mar 3, 2026 and Mar 3, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Degraded” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K033363); they may or may not involve this specific model.

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.

• InjuryMar 3, 2026Degraded

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY TEN YEARS AND SIX MONTHS POST IMPLANTATION DUE TO METALLOSIS AND POLY WEAR. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 24496472 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033363. One submission often covers many models, so check the product and lot details in each record.

• Z-1054-2018 · Nov 29, 2017 · Terminated
  ZUK PRC FEM SZB RMED/LLAT ZUK PRC FEM SZC LMED/RLAT ZUK PRC FEM SZC RMED/LLAT NGU PRC FEM SZD LMED/RLAT ZUK PRC FEM SZD RMED/LLAT ZUK PRC FEM SZE LMED/RLAT ZUK PRC FEM SZF RMED/LLA
• Z-0836-2016 · Jan 11, 2016 · Terminated
  ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer various sizes These devices are indicated for patients with: - Painful an
• Z-0076-2014 · Aug 30, 2013 · Terminated
  Zimmer Unicompartmental Knee Femoral Component. Indicated for patients with painful and/or disabling knee joint.