ZUK 00584202409Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556620168), received between Jan 5, 2019 and Feb 6, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  *US LEGAL* IT WAS REPORTED THAT AFTER THE PATIENT UNDERWENT A LEFT KNEE REVISION SURGERY FOR INSERT REPLACEMENT ON (B)(6) 2021, HE KEPT SUFFERING FROM PAIN, SWELLING AND MILD SYNOVITIS. ON (B)(6) 2021, THE PATIENT WAS ASPIRATED PRODUCING 50 CC OF SEROSANGUINEOUS FLUID AND ON (B)(6) 2021 THE PATIENT¿S LEFT KNEE WAS ASPIRATED AGAIN PRODUCING OVER 60 CC OF DARK BLOODY FLUID. THE PATIENT CONTINUED WITH ANTI-INFLAMMATORY AND PHYSICAL THERAPY. THE PATIENT IS CURRENTLY IN A LOT OF PAIN AND CONTINUES TO HAVE SWELLING IN THE KNEE, IS UNABLE TO CLIMB STAIRS OR BEND THE KNEE VERY MUCH. THE PATIENT RECEIVED A STEROID SHOT BUT DID NOT HELP WITH THE PAIN. ON (B)(6) 2022, THE PATIENT WAS RE-EVALUATED DUE TO PERSISTENT ANTERIOR KNEE PAIN WITH GRADE 3 CHONDROSIS OF THE PF COMPARTMENT (ACCORDING TO AN MRI). THE PATIENT WAS ADVISED TO HAVE A CONVERSION OF THE LEFT UKA TO A TKA, BUT HE HAS NOT DECIDED YET.

  Patient problems: Joint effusion; Pain

  MAUDE report 18655606 ↗
• InjuryMay 5, 2021Device Dislodged or Dislocated; Material Twisted/Bent; Device Dislodged or Dislocated; Material Twisted/Bent

  IT WAS REPORTED THAT, AFTER A SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT REPORTED SOME SWELLING, BUT SURGEON WAS NOT TOO CONCERNED ABOUT IT. AFTER THE PATIENT HAD LEFT THE OFFICE, THE SURGEON REVIEWED X-RAYS ON (B)(6) 2021 AND NOTICED THAT THE ARTICULAR SURFACE SIZE 4 9MM WAS LIFTED UP POSTERIORLY. THE ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY ON (B)(6) 2021, WHICH UPON OPENING THE PATIENT, IT WAS NOTICED THAT THE ARTICULAR SURFACE SIZE 4 9MM WAS DOWN IN THE FRONT/ANTERIOR, BUT AFTER PRYING IT OUT THE SURGEON COULD TELL IT HAD NOT SEATED POSTERIORLY AND UPON FURTHER INSPECTION, THE INSERT WAS BENT AS IT HAD BEEN TRAMPOLINING IN SITU. THERE WAS NOT DAMAGE TO THE FEMUR OR TIBIA BASE. ANOTHER INSERT WAS PLACED AND INSERTED USING THE APPROPRIATE TOOL. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Discomfort; Failure of Implant; Pain; Swelling/ Edema; Synovitis

  MAUDE report 11777427 ↗
• InjuryJan 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO AN INFECTION. NO PRODUCT ISSUES SUSPECTED.

  Patient problems: Unspecified Infection

  MAUDE report 8220545 ↗

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.