NA 32-8105-043-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024274099), received between Oct 4, 2023 and Feb 20, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2025Material Erosion; Material Erosion

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN I&D FOR AN EVACUATION OF A HEMATOMA APPROXIMATELY ONE (1) MONTH POSTIMPLANTATION FOLLOWING PERSISTENT SEROSANGUINEOUS DRAINAGE. DURING THE SURGERY, IT WAS FOUND THE EXTENSOR MECHANISM DETERIORATED AT THE ATTACHMENT SITE ON THE ULNA AND CULTURES WERE POSITIVE FOR KLEBSIELLA AND STAPH EPIDERMIDIS. THE BUSHING AND PIN WERE EXCHANGED WITHOUT COMPLICATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bacterial Infection; Failure of Implant; Hematoma; Impaired Healing; Muscle/Tendon Damage; Swelling/ Edema

  MAUDE report 21421802 ↗
• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Adhesion(s); Extraskeletal ossification; Loss of Range of Motion; Muscle Weakness/Atrophy; Numbness; Pain; Peripheral Nervous Injury; Scar Tissue

  MAUDE report 21366011 ↗
• InjuryOct 4, 2023Loosening 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: Adhesion(s); Bacterial Infection; Bone Fracture(s); Failure of Implant; Joint Contracture; Muscle/Tendon Damage; Pain; Seroma; Swelling/ Edema; Unspecified Infection; Wound Dehiscence

  MAUDE report 17873414 ↗

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