BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION SHOULDER SYSTEM

    MDR report key: 1053020 · Received May 27, 2008

    Report

    Report Number
    1644408-2008-00157
    Event Type
    Other
    Date Received
    May 27, 2008
    Date of Event
    April 25, 2008
    Report Date
    April 25, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - PTS ROTATOR CUFF WAS TORN AND IRREPARABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION SHOULDER SYSTEM GLENOID, PEGGED KWS ENCORE MEDICAL, L.P. 601682

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention 503-00-014