NexGen® 5880-16-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889024199163), received between Dec 13, 2023 and Aug 17, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2026Fracture

  It was reported that a patient underwent a left total knee arthroplasty. Approximately two (2) years and two (2) months post-implantation, the patient sustained a torsional injury to the implanted joint, thus resulting in instability. Radiographic evaluation revealed displacement of the hinge mechanism indicating possible implant failure of the hinge assembly. Subsequently, the patient underwent revision surgery in which the femoral hinge post was found to be fractured. The affected components were replaced without reported complication. Due diligence is in progress for this event; to date all available information has been provided.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Joint effusion; Swelling/ Edema

  MAUDE report 50284027 ↗
• InjuryDec 30, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Aseptic loosening

  MAUDE report 23921159 ↗
• InjuryAug 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY. APPROXIMATELY 4 YEARS POST-OP, THE PATIENT HEARD A POPPING NOISE IN THE SHOWER. SUBSEQUENTLY, THE PATIENT WAS REVISED AND DURING THE REVISION, THE HINGE COMPONENT WAS FOUND TO BE CRACKED WHERE THE POST THREADS INTO THE FEMORAL COMPONENT. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22882749 ↗
• InjuryJun 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL HINGED KNEE ARTHROPLASTY. APPROXIMATELY FOURTEEN (14) MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY DUE TO DISASSOCIATION OF THE FEMORAL COMPONENT. ALL COMPONENTS WERE REPLACED WITHOUT REPORTED COMPLICATION.

  Patient problems: Failure of Implant

  MAUDE report 22344883 ↗
• InjuryMay 20, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE TWO MONTHS POST IMPLANTATION DUE TO INFECTION AND LOOSENING OF FEMORAL AND ARTICULAR SURFACE PROSTHESIS. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 22052549 ↗
• InjuryMar 31, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT INITIAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO RECURRING INFECTION. IT WAS NOTED THAT THE PATIENT APPEARED TO HAVE FEMORAL LOOSENING HOWEVER WOULD HAVE REQUIRED DISTAL FEMORAL REPLACEMENT WHICH WAS UNAVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 21733521 ↗
• InjuryJul 1, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT KNEE REPLACEMENT APPROXIMATELY TWELVE MONTHS POST-IMPLANTATION DUE TO LOOSENING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 19645280 ↗
• InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE POST IMPLANTATION DUE TO UNKNOWN REASON. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18317212 ↗

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-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.