NexGen® 5988-06-26Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024220638), received between Jul 18, 2023 and Jul 18, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (1 report).

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

• InjuryJul 18, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING AN INITIAL TOTAL KNEE ARTHROPLASTY, THE OUTER STERILE PACKAGE WAS CRACKED ALONG WITH THE INNER STERILE PACKAGE OF THE TIBIAL BLOCK IMPLANT. THE INNER PEEL PACK WAS INTACT SO SURGEON OPTED TO IMPLANT THE PRODUCT AS THEY DID NOT FEEL THERE WAS A CONCERN OVER STERILITY AND A SECOND IMPLANT OF THE SAME SIZE WAS UNAVAILABLE. NO ADVERSE EVENTS OR PATIENT IMPACT HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ALL AVAILABLE INFORMATION HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17344425 ↗

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.