BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COONRAD/MORREY TOTAL ELBOW HUMERAL ASSEMBLY

    MDR report key: 1892704 · Received October 28, 2010

    Report

    Report Number
    1822565-2010-01035
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    July 16, 2010
    Report Date
    October 7, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDC
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 PATIENT WAS REVISED FOR A BROKEN IMPLANT. THE DEVICE WAS IMPLANTED IN 1996.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COONRAD/MORREY TOTAL ELBOW HUMERAL ASSEMBLY ELBOW PROSTHESIS JDC ZIMMER, INC. 34675600

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention