NexGen® 5988-04-26Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024220393), received between Apr 20, 2026 and Apr 20, 2026 — classified as 2 injuries.

3 other recalls cover devices cleared under the same FDA submission (K173057, K862632, K946150); 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.

• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY 6 YEARS AND 3 MONTHS POST-IMPLANTATION DUE TO INSTABILITY. THE PATIENT HAD A HISTORY OF RIGHT TOTAL KNEE ARTHROPLASTY INFECTION THAT WAS MANAGED WITH A PRIOR SECOND-STAGE REVISION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Laxity; Pain

  MAUDE report 24931258 ↗
• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY 6 YEARS AND 3 MONTHS POST-IMPLANTATION DUE TO INSTABILITY. THE INDEX PROCEDURE WAS A SECOND-STAGE REIMPLANTATION FOLLOWING A PRIOR RIGHT TOTAL KNEE ARTHROPLASTY INFECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Laxity; Pain

  MAUDE report 24931240 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173057, K862632, K946150. 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-0555-2010 · Feb 26, 2009 · Terminated
  Zimmer, Insall/Burstein II Modular Knee System, Tibial Wedge and 2 Screws, Size 59, 7 Deg. x 9.5 mm Height, Tivanium TI-6AL-4V Alloy, sterile; REF 5220-62-01.