ZUK 00584202408Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556620151), received between Dec 2, 2019 and Jan 30, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 reports).

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.

• InjuryJan 30, 2021Break; Break

  IT WAS REPORTED THAT DURING TOTAL KNEE ARTHROPLASTY POLY TRIAL BROKE IN HALF WHILE TRIALING. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE. NO DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11256344 ↗
• InjuryJan 18, 2021Break; Break

  IT WAS REPORTED THAT, DURING PROCEDURE, WHILE TRIALING ZUK INSERT TRIAL SIZE 4 8 MM, DEVICE BROKE. PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND NO DELAY WAS REPORTED. THE PATIENT WAS NOT HARMED BEYOND THE DESCRIBED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11187856 ↗
• MalfunctionDec 2, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY, DEVICE BROKE WHEN THE INSERT TRIAL WAS PLACED FOR TRIALING. NO DELAY. NO CONFIRMATION OF BACKUP HAS BEEN RECEIVED. NO IMPACT OR INJURY TO PATIENT REPORTED.

  Patient problems: No Information

  MAUDE report 9398445 ↗

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.