MAUDE Adverse Event Report: ZIMMER INC/ ZIMMER BIOMET COONRAD/MORREY TOTAL ELBOW INTERCHANGEABLE ULNAR ASSEMBLY; PROSTHESIS ELBOW CONSTRAINED CEMENTED

Catalog Number 32-8105-53-02

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/28/2010

Event Type  Injury  

Event Description

I slipped on some ice outside of my apartment.My foot went up and i fell down and shattered my right elbow.The doctor put screws in.They didn¿t work.So, the doctor put an elbow replacement in on (b)(6) 2011, and something went wrong, so the doctor put another replacement in on (b)(6) 2012, and something was wrong with it and the doctor replaced it, and then that one went wrong on (b)(6) 2014.I got another replacement on (b)(6) 2015.All replacements on the same arm.

• Brand Name: COONRAD/MORREY TOTAL ELBOW INTERCHANGEABLE ULNAR ASSEMBLY
• Type of Device: PROSTHESIS ELBOW CONSTRAINED CEMENTED
• Manufacturer (Section D): ZIMMER INC/ ZIMMER BIOMET
• MDR Report Key: 8396227
• MDR Text Key: 138257930
• Report Number: MW5084684
• Device Sequence Number: 2
• Product Code: JDC
• UDI-Device Identifier: 32810505302
• UDI-Public: 32810505302
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/26/2019
• 7 Devices were Involved in the Event: 1 2 3 4 5 6 7

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 32-8105-53-02
• Device Lot Number: 61971269
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 102