NexGen® 5880-60-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024199439), received between May 27, 2021 and Mar 10, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K013385, 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 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.

• InjuryMar 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 21559865 ↗
• InjuryJan 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE PATIENT UNDERWENT A KNEE REVISION APPROXIMATELY 18 MONTHS POST IMPLANTATION DUE TO PAIN, INSTABILITY, HYPERTENSIVE KNEE, EDEMATOUS, AND HEMARTHROSIS. DURING THE REVISION THE HINGE WAS REPORTED TO BE DISASSEMBLED, AND THE FEMORAL AND TIBIAL COMPONENTS WERE NOTED TO BE WELL FIXED. THE HINGE REPLACEMENT WAS COMPLETED.

  Patient problems: Failure of Implant; Joint Laxity; Joint effusion; Pain

  MAUDE report 21270017 ↗
• InjuryMay 27, 2021Naturally Worn; Noise, Audible; Naturally Worn; Noise, Audible

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

  Patient problems: Damage to Ligament(s); Failure of Implant; Joint Laxity; Local Reaction; Metal Related Pathology; Pain

  MAUDE report 11893921 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K013385, 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 0052200
• Z-1447-04 · Aug 3, 2004 · Terminated
  Zimmer brand NEXGEN Complete Knee Solution Rotating Hinge Knee Tibial Component, precoat, nonmodular, size 2, sterile, for cemented use only; Cat. No. 5880-02-02.
• Z-1448-04 · Aug 3, 2004 · Terminated
  Zimmer brand NEXGEN Complete Knee Solution Rotating Hinge Knee Tibial Component, precoat, nonmodular, size 3, sterile, for cemented use only; Cat. No. 5880-03-02.