BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION SHOULDER

    MDR report key: 1943847 · Received December 22, 2010

    Report

    Report Number
    1644408-2010-00691
    Event Type
    Other
    Date Received
    December 22, 2010
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K003324
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE SURGEON USED A HEMI SPACER UNTIL THE INFECTION WAS GONE. HE REMOVED THE HEMI AND IMPLANTED A REVERSE TOTAL SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION SHOULDER NONE KWS ENCORE MEDICAL, L.P. A1000001

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention