NexGen® 5880-90-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024199491), received between Dec 15, 2022 and Oct 14, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (2 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 16, 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.

• InjuryOct 14, 2024Fracture; Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN, INSTABILITY AND DISCOMFORT SECONDARY TO HINGE PIN LOOSENING THAT RESULTED IN FRACTURE OF THE POLYETHYLENE BOX INSERT APPROXIMATELY TWENTY MONTHS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 20439204 ↗
• InjuryDec 15, 2022Fracture; Fracture

  IT WAS REPORTED THAT PATIENT WHO UNDERWENT A PREVIOUS REVISION STARTED TO FEEL A PAIN APPROXIMATELY 1 YEAR 7 MONTHS POST REVISION. AT THE DIAGNOSIS, A NON-IMPLANT RELATED TUMOR OUT OF JOINT WAS SUSPECTED. A PROCEDURE WAS PERFORMED TO REMOVE THE TUMOR AND ADMINISTRATE ANTI-BIOTICS. IT WAS FOUND AT THAT TIME THE HINGE POST WAS FRACTURED AND WILL NEED REVISION TO CORRECT. NO PATIENT INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 15990659 ↗

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-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.