NA 5842-03-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024193635), received between Dec 16, 2022 and Mar 3, 2026 — classified as 3 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 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 24496467 ↗
• InjuryNov 22, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Arthritis; Metal Related Pathology

  MAUDE report 18190808 ↗
• InjuryDec 16, 2022Migration; Malposition of Device; Migration

  IT WAS REPORTED INITIAL RIGHT UNICOMPARTMENTAL ARTHROPLASTY. SUBSEQUENTLY REVISED 2 YEARS 7 MONTHS POST IMPLANTATION DUE TO PAIN, DECREASED ADLS, LIMITED ROM, AND MALPOSITION OF IMPLANT. DURING THE REVISION IT WAS CONFIRMED FEMUR IN VARUS POSITION AND WELL FIXED. PATIENT WAS REVISED WITHOUT COMPLICATIONS.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 15995637 ↗

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.