BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER, INC.

    MDR report key: 41686 · Received September 26, 1996

    Report

    Report Number
    56213-1996-00001
    Event Type
    Injury
    Date Received
    September 26, 1996
    Date of Event
    September 19, 1996
    Report Date
    September 19, 1996
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDC
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED WITH INFECTED ELBOW. TAKEN TO OR. FILM SHOWED PIVOT PIN WAS BACKING OUT. DR OPENED UP; POLYETHYLENE BEARING SURFACES WERE CRACKED AND BROKEN OFF. SPLIT RING STILL IN PLACE. PIVOT PIN BACKING OUT. TISSUE BLACKENED AROUND IMPLANT. REMOVED THE BROKEN/WORN POLYETHYLENE AND REPLACED WITH NEW SPLIT RING AND PIVOT PIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER, INC. Implant COONRAD MOOREY ELBOW JDC ZIMMER, INC. NA 34427600

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention