NA 32-8105-25-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889024508590), received between Nov 26, 2019 and Jul 9, 2024 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.

• InjuryJul 9, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Failure of Implant

  MAUDE report 19701087 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT ELBOW ARTHROPLASTY APPROXIMATELY SEVEN (7) AND A HALF MONTHS AGO. SUBSEQUENTLY, THE PATIENT DEVELOPED WOUND DEHISCENCE AND UNDERWENT A I&D APPROXIMATELY THREE (3) WEEKS LATER. TWO WEEKS AFTER THE I&D THE PATIENT CONTINUED WITH PAIN, SWELLING, AND UNDERWENT AN I&D AND PARTIAL STAGE ONE PROCEDURE APPROXIMATELY TWO (2) WEEKS LATER, WITH ALL IMPLANTS BEING EXPLANTED EXCEPT THE HUMERAL COMPONENT WHICH WAS WELL FIXED. THE SURGEON NOTED THAT THE ULNAR COMPONENT HAD LOOSENED, PURULENCE UPON OPENING JOINT ALONG WITH RADIAL CORTEX HAD BEEN PERFORATED BY THE ULNAR COMPONENT. AN ULNAR ANTIBIOTIC SPACER WAS IMPLANTED, AND THE PATIENT REMAINED DISLOCATED AND UNDERWENT A SIX (6) WEEKS COURSE OF ANTIBIOTICS FOR STAPH AUREUS INFECTION. THE SECOND STAGE PROCEDURE WAS PERFORMED AFTER A NEGATIVE CULTURE AND IV ANTIBIOTICS COURSE WAS COMPLETED. THE SECOND STAGE WAS PERFORMED APPROXIMATELY THREE (3) MONTHS AFTER THE FIRST STAGE. THE ULNAR IMPLANT WAS IMPLANTED. DURING THE SURGERY THE SURGEON NOTED THAT THE PATIENT'S ELBOW WAS TIGHT, FIBROUS TISSUE AND SOFT TISSUE HAD DEVELOPED CONTRACTURE. THE PATIENT WAS ONLY ABLE TO OBTAIN 45 DEGREES OF RANGE OF MOTION W

  Patient problems: Adhesion(s); Bacterial Infection; Bone Fracture(s); Failure of Implant; Joint Contracture; Muscle/Tendon Damage; Pain; Seroma; Swelling/ Edema; Wound Dehiscence

  MAUDE report 18043596 ↗
• InjuryJun 20, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO BUSHING WEAR ON THE IMPLANT CAUSING METAL-ON-METAL EROSION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 17165155 ↗
• InjuryNov 2, 2022Fracture; Fracture

  IT WAS REPORTED A PATIENT UNDERWENT AN ELBOW ARTHROPLASTY APPROXIMATELY 2 YEARS AGO. SUBSEQUENTLY, PATIENT WAS REVISED. THE COONRAD MORREY HUMERAL COMPONENT BROKE WHILE IN SITU WHILE PATIENT WAS AT HOME CARRYING OUT HOUSEHOLD TASKS. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 15714793 ↗
• InjuryAug 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING AN INITIAL RIGHT TOTAL ELBOW ARTHROPLASTY WITH ULNAR NERVE TRANSPOSITION. SUBSEQUENTLY, A SMALL, MINIMALLY DISPLACED FRACTURE OF THE PATIENT'S MEDIAL CONDYLE OCCURRED DURING THE PROCEDURE AS THE HUMERUS WAS DRIVEN IN FULLY. THE FRACTURE WAS PINNED AND THERE WAS NO FURTHER INTRA-OPERATIVE COMPLICATIONS REPORTED.

  Patient problems: Bone Fracture(s)

  MAUDE report 15300263 ↗
• 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 15275801 ↗
• InjuryAug 18, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL ELBOW SURGERY. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION PROCEDURE APPROXIMATELY SEVEN YEARS POST INITIAL SURGERY DUE TO INFECTION AND LOOSENING OF HUMERAL COMPONENT. ALL COMPONENTS WERE REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 15249232 ↗
• InjuryNov 2, 2021Adverse 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: Hyporesponsive to stimuli; Peripheral Nervous Injury

  MAUDE report 12737511 ↗
• MalfunctionNov 26, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THE PATIENT UNDERWENT A PIN AND BUSHING REVISION TO ADDRESS SEVERE PAIN. THE DEVICE WAS IDENTIFIED LOOSE UPON CLINICAL ASSESSMENT. NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORTING.

  Patient problems: Pain

  MAUDE report 9378070 ↗

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-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-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-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-