NA 5842-24-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024194021), received between Oct 14, 2020 and Nov 18, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Malposition of Device” (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 16, 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.

• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Pain

  MAUDE report 20712324 ↗
• InjuryAug 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT KNEE PROCEDURE. SUBSEQUENTLY, FOR TWO YEARS POST IMPLANTATION, THE PATIENT HAS HAD PERSISTENT AND ONGOING PAIN, SWELLING, AND DIFFICULTY WITH DAILY ACTIVITIES. THE PATIENT EXPERIENCES A SCRAPING SENSATION AND SHARP FOCAL PAIN WHEN THE KNEE IS BENT PAST 90 DEGREES. AT ONE YEAR POST IMPLANTATION, TWO ULTRASOUNDS WERE COMPLETED WHICH SUGGESTED SYNOVITIS AND DEGENERATIVE CHANGES AFFECTING THE ILIOTIBIAL BAND AND THE LATERAL COLLATERAL LIGAMENT. MEDICAL EVALUATIONS AND EXTENSIVE REHABILITATION HAVE NOT IMPROVED SYMPTOMS AND IMAGING STUDIES REPORTEDLY SHOW SEVERE IRRITATION TO THE LATERAL COLLATERAL LIGAMENT AT THE LOCATION OF THE IMPLANTED COMPONENTS. AT THIS TIME, NO FURTHER MEDICAL INTERVENTION HAS BEEN REPORTED AND THE PRODUCTS REMAIN IMPLANTED.

  Patient problems: Pain; Swelling/ Edema; Synovitis

  MAUDE report 15327574 ↗
• InjuryOct 14, 2020Malposition of Device; Malposition of Device

  IT IS REPORTED THAT THE PATIENT IS ALLEGING POOR ALIGNMENT BETWEEN THE TIBIAL AND FEMORAL PROSTHESES APPROXIMATELY SIX (6) WEEKS FOLLOWING A LEFT MEDIAL PARTIAL KNEE ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Information

  MAUDE report 10677344 ↗

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.