BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION SHOULDER

    MDR report key: 2214038 · Received August 2, 2011

    Report

    Report Number
    1644408-2011-00431
    Event Type
    Other
    Date Received
    August 2, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 22, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K003324
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO SHOULDER PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION SHOULDER STANDARD HUMERAL HEAD KWS ENCORE MEDICAL, L.P. 53873126

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention 503-00-010, LOT 53873123