NexGen® 5880-40-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024199316), received between Apr 1, 2021 and Mar 5, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 21526845 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE REVISION ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY TWO YEARS LATER DUE TO SYNOVITIS AND ARTHROFIBROSIS. A TOTAL SYNOVECTOMY WITH DEBRIDEMENT, A SECOND QUADRICEPSPLASTY, AND A POLY EXCHANGE WAS PERFORMED. THE RETAINED TIBIAL AND FEMORAL COMPONENTS WERE WELL-FIXED WITH NO SIGNS OF LOOSENING.

  Patient problems: Inflammation; Loss of Range of Motion; Scar Tissue; Synovitis

  MAUDE report 19047072 ↗
• MalfunctionMar 25, 2024Packaging Problem; Packaging Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18971470 ↗
• MalfunctionMar 24, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT WHILE RECEIVING IN A LOANER IMPLANT KIT, A WAREHOUSE TEAM MEMBER NOTICED THAT IT SOUNDED LIKE A LOOSE PIECE WAS ROLLING AROUND INSIDE OF THE BOX. THE BOX WAS OPENED AND THE INNER PACKAGING CAVITY WAS FOUND TO BE BROKEN WITH THE HINGE POST EXTENSION SCREW WAS LOOSE INSIDE THE BOX. STERILITY OF THE DEVICE WAS COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13891759 ↗
• InjuryApr 1, 2021Component Incompatible; Use of Device Problem; Component Incompatible; 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 11603084 ↗

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.