BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 2222598 · Received August 16, 2011

    Report

    Report Number
    1644408-2011-00463
    Event Type
    Other
    Date Received
    August 16, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 9, 2011
    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 - THE PT COMPLAINED OF INSTABILITY, THE DOCTOR WENT BACK AND PUT IN A NEW IMPLANT TO TIGHTEN THE SOFT TISSUE TENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER HUMERAL SOCKET SHELL, NEUTRAL KWS ENCORE MEDICAL, L.P. 53946849

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention