BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 1943667 · Received December 14, 2010

    Report

    Report Number
    1644408-2010-00665
    Event Type
    Other
    Date Received
    December 14, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO INFECTION, NOT CAUSED BY PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER HUMERAL SOCKET INSERT KWS ENCORE MEDICAL, L.P. A1000002

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention (B)(4), LOT 54036029| (B)(4), LOT 54051076