NexGen® 5880-40-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889024199309), received between Jun 22, 2020 and Nov 25, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Fracture” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Joint Laxity; Loss of Range of Motion

  MAUDE report 23650635 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE PROCEDURE. APPROXIMATELY 8.5 YEARS LATER, THE PATIENT ARTICULAR SURFACE WAS REVISED DUE TO INSTABILITY. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22513167 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Joint Laxity

  MAUDE report 22420680 ↗
• InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Discomfort; Loss of Range of Motion

  MAUDE report 19688911 ↗
• InjuryJun 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Scar Tissue

  MAUDE report 17154171 ↗
• InjurySep 29, 2022Unstable; Unstable

  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 15503263 ↗
• InjuryAug 7, 2020Fracture; Fracture

  IT WAS REPORTED PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY THE PATIENT WAS REVISED APPROXIMATELY TWO WEEKS POST IMPLANTATION DUE TO PAIN AND SWOLLEN KNEE. DURING SURGERY IMPLANT FRACTURE WAS DISCOVERED. POST IMPLANTATION PATIENT IS IN GENERAL CONDITION AND IRRITATION FREE, BUT STILL SLIGHTLY SWOLLEN WOUND CONDITIONS FROM ACUTE INPATIENT TREATMENT FIRST RELEASED INTO THEIR HOME ENVIRONMENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pain; Swelling

  MAUDE report 10378484 ↗
• InjuryJun 22, 2020Migration; Migration

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY EIGHT MONTHS¿ POST IMPLANTATION DUE TO POST-SURGICAL PAIN. IT IS FURTHER REPORTED THAT THE SCREW BACKED OUT OF THE HINGE POST. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 10178435 ↗

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.