NexGen® 5880-30-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024199248), received between Apr 27, 2020 and Nov 17, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 2025Fracture; Fracture

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Loss of Range of Motion; Pain

  MAUDE report 23572276 ↗
• InjuryDec 15, 2022Fracture; Fracture

  IT WAS REPORTED THAT PATIENT WHO UNDERWENT A PREVIOUS REVISION STARTED TO FEEL A PAIN APPROXIMATELY 1 YEAR 7 MONTHS POST REVISION. AT THE DIAGNOSIS, A NON-IMPLANT RELATED TUMOR OUT OF JOINT WAS SUSPECTED. A PROCEDURE WAS PERFORMED TO REMOVE THE TUMOR AND ADMINISTRATE ANTI-BIOTICS. IT WAS FOUND AT THAT TIME THE HINGE POST WAS FRACTURED AND WILL NEED REVISION TO CORRECT. NO PATIENT INFORMATION AVAILABLE.

  Patient problems: Failure of Implant; Pain

  MAUDE report 15990637 ↗
• InjuryApr 27, 2020Unstable; Device Dislodged or Dislocated; Noise, Audible; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Device Dislodged or Dislocated; Noise, Audible; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED PATIENT UNDERWENT INITIAL LEFT ROTATING HINGE TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT IRRIGATION AND DEBRIDEMENT WITH POLY EXCHANGE TWO WEEKS LATER DUE TO WOUND COMPLICATIONS. WITHOUT A KNOWN TRAUMATIC EVENT, THE PATIENT EXPERIENCED CRACKING AND INSTABILITY IN THE JOINT AND PRESENTED TO THE ER. X-RAYS SHOWED PROSTHESIS LUXATION WITH A LOOSENED COUPLING MECHANISM. THE PATIENT UNDERWENT A SECOND REVISION DURING WHICH THE POLY WAS EXCHANGED WITHOUT COMPLICATION APPROXIMATELY TWO MONTHS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 10000571 ↗

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.