NA 32-8105-27-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889024274006), received between Jul 16, 2021 and Mar 31, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Fracture” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Insufficient Information

  MAUDE report 21733109 ↗
• 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 21459380 ↗
• InjuryFeb 12, 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; Pain

  MAUDE report 21366022 ↗
• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RESECTION OF HETEROTOPIC BONE AND AN ULNAR NERVE TRANSPOSITION DUE TO NUMBNESS AND TINGLING OF THE ULNAR DIGITS APPROXIMATELY SIX (6) MONTHS POST-IMPLANTATION. SUBSEQUENTLY, THE PATIENT UNDERWENT A SECOND ULNAR NERVE TRANSPOSITION APPROXIMATELY EIGHT (8) MONTHS LATER. BOTH PROCEDURES WERE COMPLETED WITHOUT COMPLICATION AND ALL ORIGINAL IMPLANTS REMAIN IN PLACE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

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

  MAUDE report 21366018 ↗
• InjuryNov 7, 2024Fracture; Fracture

  BASED ON THE REVIEW OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THIS MEDWATCH REPORT IS A DUPLICATE OF 1822565 -2024 -03501. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

  Patient problems: Failure of Implant

  MAUDE report 20634387 ↗
• InjuryNov 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ELBOW ARTHROPLASTY WITH A NON-ZIMMER BIOMET PRODUCT APPROXIMATELY TWENTY-ONE (21) YEARS AGO. THE PATIENT WAS THEN REVISED APPROXIMATELY TWELVE (12) YEARS LATER USING A COONRAD-MORREY SYSTEM FOR AN UNKNOWN REASON. THE PATIENT UNDERWENT A SECOND AND THIRD REVISION TO REVISE THE LINK PIN AND BUSING APPROXIMATELY FOUR (4) YEARS LATER. APPROXIMATELY ONE (1) YEAR AND SEVEN (7) MONTHS AGO THE PATIENT REPORTED PAIN AND A POP. X-RAYS WERE PERFORMED AND A THE IMPLANT HAD FRACTURED. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY FIVE (5) MONTHS AGO TO REVISE THE FRACTURED IMPLANT. THE PATIENT DENIES ANY TRAUMA THAT WOULD HAVE CAUSED THE IMPLANT TO FRACTURE.

  Patient problems: Osteopenia/ Osteoporosis

  MAUDE report 20624144 ↗
• InjuryOct 11, 2024Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE IMPLANT DIDN'T HOLD UP AFTER 7 YEARS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Insufficient Information; Metal Related Pathology; Pain; Scar Tissue

  MAUDE report 20427183 ↗
• InjuryMay 23, 2023Adverse 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: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 16984831 ↗
• 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 12180083 ↗

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-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-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-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-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-