BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION

    MDR report key: 1230280 · Received November 7, 2008

    Report

    Report Number
    1644408-2008-00405
    Event Type
    Other
    Date Received
    November 7, 2008
    Date of Event
    October 27, 2008
    Report Date
    October 27, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K003324
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    A FAILED HEMIARTHROPLASTY DUE TO A FAILED ROTATOR CUFF WAS REMOVED, AND THE SURGEON REPLACED IT WITH A RSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION HUMERAL STEM KWS ENCORE MEDICAL, L.P. 53855815

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention LOT# 932661