NexGen® 5880-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024198999), received between Jan 22, 2020 and Nov 27, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 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.

• InjuryNov 27, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

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

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 20797190 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY. DURING THE PROCEDURE, THE PATIENT'S TIBIA FRACTURED. THE SURGERY WAS COMPLETED WITHOUT FURTHER ISSUE.

  Patient problems: Bone Fracture(s)

  MAUDE report 15503355 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT LEFT KNEE ARTHROPLASTY. SUBSEQUENTLY, PATIENT REPORTS PAIN, DECREASED MOBILITY, INSTABILITY, AND CANNOT WALK WITHOUT ASSISTANCE. NO REVISION PROCEDURE HAS BEEN REPORTED.

  Patient problems: Pain

  MAUDE report 15503258 ↗
• InjuryJan 22, 2020Unstable; Unstable

  IT WAS REPORTED THAT APPROXIMATELY 18 MONTHS POST IMPLANTATION, THE PATIENT EXPERIENCED A FALL AND SUFFERED PAIN AND INSTABILITY. UPON X-RAY IMAGING, IT WAS IDENTIFIED THAT THE YOKE HAD FRACTURED. SUBSEQUENTLY, THE PATIENT WAS REVISED AND ALL FRACTURED COMPONENTS WERE EXCHANGED. DURING THE REVISION, THERE WAS FLUID NOTED IN THE KNEE JOINT AND DAMAGE NOTED TO THE POLY BEARING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Fall; Pain

  MAUDE report 9616041 ↗

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.