NexGen® 5880-15-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00889024199149), received between Oct 10, 2019 and Jun 11, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Fracture” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2025Fracture; Unstable; Fracture; Unstable

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

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Pain; Rash

  MAUDE report 22183621 ↗
• 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 20465761 ↗
• InjuryApr 2, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE KNEE REVISION APPROXIMATELY FIVE YEARS POST-IMPLANTATION DUE TO IMPLANT FRACTURE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19020025 ↗
• InjuryOct 10, 2023Fracture; Fracture

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

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17906081 ↗
• InjurySep 14, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION TOTAL KNEE ARTHROPLASTY. APPROXIMATELY ONE YEAR AND NINE MONTHS POST-IMPLANTATION, THE PATIENT BEGAN TO EXPERIENCE PAIN, INSTABILITY, IMMOBILITY AND MODERATE JOINT EFFUSION. DIAGNOSTIC IMAGES REVEALED THAT THE LOCKING BAR COMPONENT OF THE ARTICULAR SURFACE HAD FRACTURED. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY. DURING THE SURGERY, THE KNEE JOINT WAS FOUND TO BE UNCOUPLED FROM THE CONNECTOR DUE TO BREAKAGE OF THE LOCKING BOLT AS WELL AS DORSAL DISLOCATION OF THE ARTICULAR SURFACE AND LOOSENING OF THE CEMENTED FEMORAL COMPONENT. THE FEMORAL COMPONENTS AND ARTICULAR SURFACE WERE REVISED WITHOUT COMPLICATION. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS HAVE BEEN MADE; ALL AVAILABLE INFORMATION HAS BEEN REPORTED.

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

  MAUDE report 17745658 ↗
• InjuryAug 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: Failure of Implant

  MAUDE report 17490381 ↗
• InjuryMar 2, 2022Unstable; Detachment of Device or Device Component; Migration; Unstable; Detachment of Device or Device Component; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION TO ADDRESS THE FEMORAL SCREW BACKING OUT APPROXIMATELY TEN (10) MONTHS POST-OPERATIVELY AND REPAIR A QUARTER-SIZE HOLE IN THE QUADRICEPS TENDON. THE PATIENT COMPLETED SEVEN (7) WEEKS OF STABILIZATION WITH A FULL-LENGTH LEG CAST AND THEN RECEIVED A FULL LEG BRACE RESTRICTING TO 60 DEGREES AND PHYSICAL THERAPY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

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

  MAUDE report 13655963 ↗
• 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 12348756 ↗
• InjuryJul 20, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A PATIENT WAS REVISED DUE TO HINGE POST WAS DISLOCATED FROM ROTATING HINGE KNEE FEMORAL HINGE AND ARTICULAR SURFACE WAS DISLOCATED FROM TIBIAL COMPONENT. ATTEMPTS HAVE BEEN MADE, BUT THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 12196293 ↗
• InjuryOct 10, 2019Material Erosion; Fracture; Material Erosion; Fracture

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY TWO AND HALF YEARS POST IMPLANTATION DUE TO IMPLANT FRACTURE. PATIENT EXPERIENCED LEFT KNEE PAIN AND DIFFICULTY AMBULATING. LEFT KNEE REVISION PERFORMED, NOTED THE HINGE HAD FRACTURED AND FRAGMENT HAD MIGRATED, ALONG WITH POLY FRACTURE. PATIENT HAD TENDON TEAR REPAIRED WITH ANCHORS. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: Limited Mobility Of The Implanted Joint; Loss of Range of Motion; No Information; Pain; Scar Tissue; Swelling; Tissue Damage

  MAUDE report 9176594 ↗

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.