ZUK 00584202608Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556620274), received between Dec 17, 2018 and Mar 15, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY TOOK PLACE ON (B)(6) 2021, DUE TO AN INFECTION IN THE PATIENT KNEE. THE CONCERN IS THE SIGNIFICANT AMOUNT OF WEAR THE ARTICULAR SURFACE SIZE 6 8MM SHOWS FROM THE SHORT AMOUNT OF TIME IT WAS IMPLANTED. PRIMARY SURGERY TOOK PLACE ON (B)(6) 2021. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 11479296 ↗
• MalfunctionDec 17, 2018Break; Break

  IT WAS REPORTED THAT DURING SURGERY, TRIAL SPLIT IN 2 PIECES. THERE WAS NO DELAY, NO INJURY, NO BACKUP DEVICE AVAILABLE, HAD TO DIVERT FROM ORIGINAL PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8172022 ↗

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.