BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COONRAD/MORREY TOTAL ELBOW INTERCHANGEABLE ULNAR ASSEMBLY

    MDR report key: 1220795 · Received October 31, 2008

    Report

    Report Number
    1822565-2008-00751
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    September 17, 2008
    Report Date
    October 1, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE LABELS STATE "ENSEMBLE HUMERAL" AND "ENSEMBLE CUBITAL" ON THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COONRAD/MORREY TOTAL ELBOW INTERCHANGEABLE ULNAR ASSEMBLY ELBOW PROSTHESIS JDB ZIMMER, INC. NA 60528971

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK