BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 2214071 · Received August 2, 2011

    Report

    Report Number
    1644408-2011-00447
    Event Type
    Other
    Date Received
    August 2, 2011
    Date of Event
    July 28, 2011
    Report Date
    July 28, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO AN INFECTED SHOULDER. THE SURGEON PERFORMED I AND D, REPLACED THE HEAD, AND SHELL SOCKET INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER GLENOID HEAD W/RETAINING SCREW, NEUTRAL KWS ENCORE MEDICAL, L.P. 86961036

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention 508-00-004, LOT 852C1002| 508-01-036, LOT 54507661