NA 32-8105-043-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024274105), received between Jul 16, 2021 and Feb 25, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K053189, K181307); 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.

• InjuryFeb 25, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 21459391 ↗
• InjuryNov 29, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO FRACTURED AND DISASSOCIATED IMPLANT. THE BEARING AND HINGE WERE REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 18226255 ↗
• InjuryMay 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL SURGERY APPROXIMATELY 2 YEARS AGO. SUBSEQUENTLY, THE PATIENT IS EXPERIENCING PAIN SECONDARY TO A POSSIBLE COBALT CHROME ALLERGY. A FUTURE REVISION PROCEDURE IS INDICATED; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 16984818 ↗
• InjuryAug 23, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Noise, Audible; Patient Device Interaction Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Noise, Audible; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL RIGHT TOTAL ELBOW ELEVEN (11) YEARS AND THREE (3) MONTHS AND HAD STARTED TO EXPERIENCE PAIN, SWELLING, AND A SQUEAKING NOISE. SUBSEQUENTLY, THE PATIENT UNDERWENT A RIGHT ELBOW REVISION SURGERY DUE TO IMPLANT FAILURE DUE TO IMPLANT WEAR AND METALLOSIS. DURING THE PROCEDURE, THE SURGEON NOTED CHRONIC CHANGES, SCAR TISSUE AND HETEROTOPIC BONE.

  Patient problems: Extraskeletal ossification; Failure of Implant; Metal Related Pathology; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 15275834 ↗
• InjuryJul 16, 2021Malposition of Device; Expulsion; Malposition of Device; Expulsion

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

  Patient problems: Failure of Implant

  MAUDE report 12180082 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K053189, K181307. One submission often covers many models, so check the product and lot details in each record.

• Z-1055-2009 · Jan 30, 2009 · Terminated
  Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, left, 3 inch length, sterile, Zimmer, Warsaw, IN; REF 32-8105-043-01. The device is
• Z-1056-2009 · Jan 30, 2009 · Terminated
  Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, right, 3 inch length, sterile, Zimmer, Warsaw, IN; REF 32-8105-043-02. The device i