NexGen® Trabecular Metal® 00-5954-057-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024208285), received between Jun 6, 2023 and Jun 6, 2023 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT EXPERIENCED A POP IN THE POSTERIOR KNEE, PAIN AND AN EFFUSION FROM HEMARTHROSIS SEVENTEEN DAYS POST IMPLANTATION. PATIENT UNDERWENT AN IN OFFICE ASPIRATION, FOLLOWED BY A SECOND ASPIRATION, DUE TO A RECURRENT EFFUSION. ASPIRATIONS WERE COMPLETED WITHOUT COMPLICATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Joint effusion; Pain

  MAUDE report 17073504 ↗

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