BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION SHOULDER

    MDR report key: 1960272 · Received January 7, 2011

    Report

    Report Number
    1644408-2011-00009
    Event Type
    Other
    Date Received
    January 7, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 22, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K950594
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE HEAD WAS TOO LARGE, CAUSING DIFFICULTY IN MOBILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION SHOULDER HUMERAL HEAD KWS ENCORE MEDICAL, L.P. 53855823

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention 503-00-008, LOT 54048950