NA 32-8105-27-01 (REF 32-8105-027-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024639768), received between Jun 6, 2022 and Jan 3, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

10 other recalls cover devices cleared under the same FDA submission (K001989, 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 3, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH LOOSENING OF THE PROSTHESIS APPROXIMATELY TWO MONTHS POST IMPLANTATION. NO FURTHER INTERVENTION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Aseptic loosening; Failure of Implant

  MAUDE report 21066862 ↗
• InjuryOct 15, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOUR YEARS POST INITIAL IMPLANTATION DUE TO REVISION DUE TO IMPLANT FRACTURE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 20454175 ↗
• InjuryJun 26, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL ELBOW REPLACEMENT AND SUBSEQUENTLY WAS REVISED APPROXIMATELY THIRTEEN YEARS POST IMPLANTATION DUE TO MEDIAL CONDYLE FRACTURE AND PIN FRACTURE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 17202084 ↗
• InjuryJun 21, 2023Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE IMPLANT WAS FOUND TO BE DISASSOCIATED APPROXIMATELY 13 DAYS POST IMPLANTATION. A REVISION PROCEDURE HAS BEEN INDICATED BUT NOT YET CONDUCTED. 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 17172582 ↗
• InjuryMay 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS APPROXIMATELY SEVEN DAYS POST INITIAL PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 16985019 ↗
• InjuryJun 6, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY ONE (1) YEAR AND TEN (10) MONTHS POST-IMPLANTATION DUE TO POLY WEAR AND PAIN. IT WAS NOTED BY THE SURGEON THERE WAS PATIENT NON-COMPLIANCE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 14607467 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K001989, K181307. One submission often covers many models, so check the product and lot details in each record.

• Z-1000-2020 · Dec 12, 2019 · Terminated
  Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Model No. 32-8105-027-04. UDI (01)00889024274006 (17)241031(10)64481139 The device is a Humeral component;
• Z-0301-2020 · Oct 10, 2019 · Terminated
  Coorad Morrey Total Elbow, Item Nos. 32810502501 32810502701 32810502900 32810503000 32810600012 32810600013 32855510796 32855510797 32855510799 32855510800 32855510801
• Z-1239-2018 · Jan 24, 2018 · Terminated
  Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912)
• Z-2752-2016 · Aug 16, 2016 · Terminated
  Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This product is sold sterile. The parts are placed into an inner cavity and are sealed using a nitrogen process
• Z-0538-2013 · Nov 19, 2012 · Terminated
  Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regular Humerals STERILE Rx, Tivanium QTY/PKG:1 Product Usage: The ulnar and humeral components are connec
• Z-1054-2009 · Jan 30, 2009 · Terminated
  Zimmer Coonrad/Morrey Total Elbow, Interchangeable Humeral Assembly, extra small, 6 inch length, sterile, Zimmer Inc, Warsaw, IN; REF 32-8105-027-06. The device is utilized for a
• Z-1058-2009 · Jan 30, 2009 · Terminated
  Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, right, long, sterile, Zimmer, Warsaw, IN; REF 32-8105-093-02. The device is utilize
• Z-1057-2009 · Jan 30, 2009 · Terminated
  Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, left, long, sterile, Zimmer, Warsaw, IN; REF 32-8105-093-01. The device is utilized
• Z-1053-2009 · Jan 30, 2009 · Terminated
  Zimmer Coonrad/Morrey Total Elbow, Interchangeable Humeral Assembly, extra small, 4 inch length, sterile, Zimmer Inc., Warsaw, IN; REF 32-8105-027-04. The device is utilized for a
• Z-0767-04 · Mar 16, 2004 · Terminated
  Zimmer brand Coonrad/Morrey total elbow interchangeable ulnar assembly, small, left, 3 in. length. tivanium TI-6AL-4V alloy/UHMWPE, sterile, for use with bone cement. Cat. no. 32-