NexGen® 5880-14-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889024199125), received between Apr 3, 2020 and Sep 28, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Fracture” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Fracture

  Patient problems: Pain

  MAUDE report 50914990 ↗
• InjuryJul 14, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE HINGE POST OF A ROTATING FEMORAL COMPONENT FRACTURED. THE PATIENT PRESENTED WITH KNEE HYPEREXTENSION. THE FEMORAL COMPONENT WAS REVISED, AND A NEW ARTICULAR SURFACE WAS ALSO INSERTED. THE SURGICAL TECHNIQUE WAS UTILIZED; THERE WAS NO SURGICAL DELAY OR FOREIGN BODIES RETAINED. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22495385 ↗
• InjuryMar 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT HAD A REVISION LEFT TOTAL KNEE ARTHROPLASTY TO A ROTATING HINGE KNEE APPROXIMATELY TWO YEARS POST IMPLANTATION DUE TO IMPLANT DISSOCIATION AND HINGE SEPARATION FAILURE. THE HINGE COMPONENT OF THE FEMUR WAS REMOVED AND REPLACED, THE ARTICULAR SURFACE POLY AND PIN WAS REPLACED, AND THE TIBIAL BUSHING WAS REPLACED AS PER SURGICAL TECHNIQUE.

  Patient problems: Failure of Implant; Loss of Range of Motion

  MAUDE report 21526842 ↗
• InjuryDec 10, 2024Use of Device Problem; Use of Device Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20894449 ↗
• InjuryNov 20, 2024Loosening 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: Failure of Implant

  MAUDE report 20733480 ↗
• InjuryAug 14, 2024Loosening 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: Failure of Implant

  MAUDE report 19980860 ↗
• 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 19688998 ↗
• 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 15502998 ↗
• InjuryApr 3, 2020Fracture; Unstable; Fracture; Unstable

  IT WAS REPORTED PATIENT¿S KNEE WAS REVISED APPROXIMATELY ONE DAY POST IMPLANTATION DUE TO INSTABILITY AND IMPLANT FRACTURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: No Code Available

  MAUDE report 9920931 ↗

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.