NexGen® 5880-60-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889024199422), received between Apr 29, 2020 and Aug 5, 2026 — classified as 8 injuries.

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

• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the patient underwent a right total knee arthroplasty and was subsequently revised approximately 1 year and 6 months post-implantation due to instability and mechanical loosening. Subsequently, 3 months after the revision, the patient began experiencing pain, swelling, stiffness, fever in the knee, and limitations in normal activities following the procedure. The devices remain implanted. Attempts have been made and no further information has been provided.

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema

  MAUDE report 50143753 ↗
• InjuryDec 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY. APPROXIMATELY FIVE (5) MONTHS POST-IMPLANTATION, THE COUPLED KNEE PROSTHESIS HAD BECOME UNCOUPLED, RESULTING IN KNEE DISLOCATION. THE FEMORAL, TIBIAL, AND RETROPATELLAR COMPONENTS WERE FOUND TO BE WELL-ANCHORED AND INTACT HOWEVER THE AXLE BOLT HAD DISENGAGED FROM THE RETAINING BUSHING. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY TO REPLACE THE INLAY AND LOOSE AXIS WITHOUT COMPLICATION. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS HAVE BEEN MADE HOWEVER ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation; Joint Laxity; Pain

  MAUDE report 23874073 ↗
• InjuryJun 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT KNEE SURGERY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT FELL AND THE RHK AXLE PIN CAME LOOSE AND THE PATIENT WAS REVISED. THE AXLE PIN AND INLAY WERE REPLACED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Fall

  MAUDE report 22197468 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY WITH COMPETITOR PRODUCT WHICH WAS FULLY REVISED SIX YEARS POST IMPLANTATION DUE TO OSTEOLYSIS AND ASEPTIC LOOSENING. SUBSEQUENTLY, THE PATIENT REPORTED PAIN, FEVER, AND DRAINAGE FROM THE INCISION SITE THREE WEEKS POSTOP. THE PATIENT UNDERWENT AN UNCOMPLICATED INCISION AND DRAINAGE WITH POLY EXCHANGE. CULTURES WERE OBTAINED, BUT NO RESULTS HAVE BEEN PROVIDED.

  Patient problems: Fever; Fluid Discharge; Pain; Wound Dehiscence

  MAUDE report 21926502 ↗
• InjurySep 11, 2024Fracture; Fracture

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

  Patient problems: Failure of Implant

  MAUDE report 20193138 ↗
• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY FIVE (5) YEARS POST-IMPLANTATION DUE TO PAIN AND LAXITY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Laxity; Pain

  MAUDE report 19483545 ↗
• InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE POST IMPLANTATION DUE TO UNKNOWN REASON. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18317787 ↗
• InjuryApr 29, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Code Available

  MAUDE report 10008862 ↗

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.