ZUK 00584202509Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556620229), received between Feb 9, 2021 and Feb 16, 2021 — classified as 2 injuries.

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

• InjuryFeb 16, 2021Break; Break

  IT WAS REPORTED THAT, DURING A UKR PROCEDURE, AN ARTICULAR SURFACE PROVISIONAL SZ 5 8MM DEVICE BROKE IN HALF LENGTH-WISE WHEN THE SURGEON WAS INSERTING. THERE WERE 2 PIECES, NOTHING WAS LEFT IN THE PATIENT. THEN, AN ARTICULAR SURFACE PROVISIONAL SZ 5 9MM DEVICE BROKE, TOO. THE KNEE WAS TOO TIGHT, THE SURGEON FORCED IT IN AND IT BROKE. NO PIECES WERE LEFT INSIDE THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. SURGERY WAS NOT DELAYED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11335572 ↗
• InjuryFeb 9, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, ARTICULAR SURFACE SIZE 5 8MM BROKE WHILE INSIDE THE PATIENT. NO PIECES WERE LEFT INSIDE THE PATIENT. IT IS UNKNOWN HOW WAS THE PROCEDURE CONCLUDED. NO DELAY OCCURRED DUE TO THIS EVENT AND PATIENT WAS NOT HARMED BEYOND THE DESCRIBED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11305579 ↗

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.