NexGen® 5880-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024199064), received between Jan 7, 2020 and Jun 26, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Malposition of Device” (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.

• InjuryJun 26, 2024Malposition of Device; Malposition of Device

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

  Patient problems: Failure of Implant; Joint effusion; Pain

  MAUDE report 19616160 ↗
• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO CHRONIC INFECTION. ALL COMPONENTS WERE REVISED WITHOUT COMPLICATIONS.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 17615114 ↗
• InjuryJan 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT KNEE REVISION DUE TO A PERIPROSTHETIC DISTAL FEMORAL FRACTURE. DURING THE SURGERY, THE SURGEON BECAME AWARE THAT THE HOSPITAL DID NOT HAVE THE CORRECT CEMENT TO IMPLANT THE DEVICES. THE SURGEON IMPLANTED THE PATIENT WITHOUT CEMENT. SUBSEQUENTLY, THE PATIENT WAS BROUGHT BACK INTO SURGERY 4 HOURS LATER WHEN THE SURGEON CORRECTLY IMPLANTED THE DEVICES.

  Patient problems: No Information

  MAUDE report 9558604 ↗

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.