NexGen® 5880-15-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024199156), received between Oct 26, 2021 and Oct 29, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THE PATIENT WAS REVISED FOR FEMORAL LOOSENING TWO YEARS, THREE MONTHS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening

  MAUDE report 23417828 ↗
• InjuryApr 30, 2024Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 19212520 ↗
• InjuryAug 10, 2022Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THE PATIENT HAD INCREASING PAIN IN THE AREA OF THE RIGHT KNEE JOINT WITHOUT REMEMBERING ANY TRAUMA, APPROXIMATELY 5 YEARS AFTER IMPLANTATION OF ONE AXIS-GUIDED KNEE PROSTHESIS AS PART OF A KTEP. FURTHER DIAGNOSTICS SHOW RADIOLOGICALLY A SHAFT FRACTURE OF THE FEMORAL COMPONENT AT THE TRANSITION FEMORAL SHIELD/PROSTHESIS. IN THE IMMEDIATE VICINITY, SMALLER METAL-DENSE STRUCTURES THAT ARE CLINICALLY DEM CORRESPOND TO THE BROKEN CONE OF THE FEMORAL SHIELD. THE DISTAL FEMORAL COMPONENT IS LOOSE. BONE SHOWS A METAPHYSEAL DEFECT SITUATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Adhesion(s); Failure of Implant; Metal Related Pathology; Osteopenia/ Osteoporosis; Pain; Scar Tissue; Synovitis

  MAUDE report 15198202 ↗
• 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 14754780 ↗
• InjuryOct 26, 2021Unstable; Unstable

  THE FEMORAL COMPONENT REMAINS IMPLANTED IN THE PATIENT, HOWEVER, THE HINGE KIT THAT WAS A PART OF THIS ITEM WAS REVISED AND WILL BE RETURNED. THERE WAS NO SURGICAL DELAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 12698619 ↗

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.