NexGen® 5880-50-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024199361), received between Aug 20, 2021 and Oct 20, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Unstable” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 20, 2025Fracture; Migration; Fracture; Migration

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

  Patient problems: Insufficient Information

  MAUDE report 23335048 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY FIVE MONTHS POST-IMPLANTATION DUE TO STIFFNESS. THE FEMORAL AND INSERT WERE REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20464544 ↗
• InjuryJul 11, 2023Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, ONE YEAR AND NINE MONTHS POST-IMPLANTATION, DIAGNOSTIC IMAGES REVEALED THAT THE LOCKING BAR COMPONENT OF THE ARTICULAR SURFACE HAS FRACTURED. THE PATIENT UNDERWENT REVISION SURGERY OF THE ARTICULAR SURFACE WITHOUT REPORTED COMPLICATION. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Joint Dislocation; Joint effusion; Pain

  MAUDE report 17297841 ↗
• InjuryNov 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, BETWEEN SIX TO EIGHTEEN MONTHS POST-IMPLANTATION, THE ROTATING HINGE POST BACKED OUT. THE PATIENT UNDERWENT REVISION SURGERY TO REPLACE THE ARTICULAR SURFACE AND HINGE POST. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 15814937 ↗
• InjuryJun 21, 2022Unstable; Adverse Event Without Identified Device or Use Problem; Migration; Unstable; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY. APPROXIMATELY 9 MONTHS LATER, THE PATIENT WAS REVISED AS THEIR KNEE WAS IN 15 DEGREE RECURVATUM. A NEW FEMORAL COMPONENT WAS IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Hyperextension; Pain; Swelling/ Edema

  MAUDE report 14754757 ↗
• InjuryMar 28, 2022Unstable; Detachment of Device or Device Component; Unstable; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY NINE AND A HALF MONTHS POST IMPLANTATION DUE TO DISLOCATION, TORN QUADRICEPS TENDON, INSTABILITY, BURSITIS, AND EFFUSION. THE BEARING AND POLYETHYLENE WERE EXCHANGED AND QUADRICEP REPAIR DONE WITHOUT COMPLICATIONS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Inflammation; Joint Dislocation; Muscle/Tendon Damage; Scar Tissue; Swelling/ Edema; Synovitis

  MAUDE report 13928449 ↗
• InjuryAug 20, 2021Unstable; Insufficient Device Problem Information; Unstable; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY FOUR YEARS AND TEN MONTHS¿ POST IMPLANTATION DUE TO UNKNOWN REASONS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 12348764 ↗

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.