NexGen® Trabecular Metal® 00-5954-037-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024208254), received between Jul 13, 2022 and Dec 19, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K072160, K173057); 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 19, 2023Migration; Migration

  NO ADDITIONAL INFORMATION.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18357832 ↗
• InjuryJul 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IS EXPERIENCING SEVERE PAIN IN THE KNEE SEVERAL YEARS AFTER A RIGHT TOTAL KNEE ARTHROPLASTY. THE PATIENT REPORTED THAT THE KNEE FELT WARM TO THE TOUCH AND THERE IS A BURNING, STABBING CONSTANT PAIN THAT GETS WORSE WHEN SHE SITS OR STANDS. THE PATIENT HAD X-RAYS DONE WHICH SHOWED NOTHING WRONG. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 15005322 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072160, K173057. One submission often covers many models, so check the product and lot details in each record.

• Z-2092-2023 · May 19, 2023 · Terminated
  NexGen Precoat Stemmed Tibial Plate Size 5
• Z-0321-2020 · Oct 10, 2019 · Terminated
  Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. 00522000100 00522000200 00522000300 00522000400 00522006304 00522006504 00522006600 00522006800
• Z-1064-2010 · Nov 16, 2009 · Terminated
  Zimmer NexGen Complete Knee Solution Minimally Invasive Solutions Procedures Trabecular Metal Technology Tibial Tray, fixed bearing, size 8, sterile, Zimmer, Warsaw, Indiana; REF 0