NexGen® 5880-60-17Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024199446), received between Oct 22, 2019 and Apr 10, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2023Fracture; Fracture

  IT WAS REPORTED THAT PATIENT UNDERWENT A ROTATING HINGE KNEE PROCEDURE. SUBSEQUENTLY, RADIOGRAPHS SEEM TO INDICATE THE HINGE POST HAS FRACTURED. NO REVISION PROCEDURE HAS BEEN REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 16709309 ↗
• InjuryOct 6, 2022Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT UNDERWENT A LEFT KNEE PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED AFTER THE THREAD ON THE HINGE POST EXTENSION FRACTURED, LEADING TO THE POST EXTENSION BACKING OUT, AND THE KNEE TO DISLOCATE.

  Patient problems: Joint Dislocation

  MAUDE report 15552172 ↗
• InjuryJul 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY TWO MONTHS POST IMPLANTATION DUE TO DISLOCATION OF THE ARTICULAR SURFACE. THE PEG THAT SCREWS INTO THE FEMUR WAS STRIPPED AND NOT LOCKED IN ANYMORE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 14931566 ↗
• InjuryOct 22, 2019Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY SIX WEEKS POST IMPLANTATION DUE TO THE HINGE-POST BACKING OUT AND INLAY SUBLUXATION. PATIENT COMPLAINED ABOUT PAIN SINCE IMPLANTATION. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 9220732 ↗

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
• 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.
• 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.