ZUK 00584200301Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556619759), received between Apr 3, 2019 and Dec 14, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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.

• InjuryDec 14, 2021Fracture; Fracture

  IT WAS REPORTED THAT, AFTER AN UKA ON (B)(6) 2021 PERFORMED 8 YEARS AGO, WHILE GETTING OUT OF THE TRUCK, THE PATIENT FELT SOMETHING. IT WAS DETERMINED THAT THE TIB BASE SZ 3 LM/RL FRACTURED. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO REMOVE ALL THE IMPLANTS. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Discomfort; Failure of Implant

  MAUDE report 13002721 ↗
• InjuryApr 3, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT IS PRESENTING PAIN ON ITS LEFT KNEE. MEDICAL ASSESSMENT CONFIRMS LOOSENING OF IMPLANTS. NO PROCEDURE HAS BEEN PERFORMED TO CORRECT THE ISSUE.

  Patient problems: Injury

  MAUDE report 8480602 ↗

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.