BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 2170239 · Received July 5, 2011

    Report

    Report Number
    1644408-2011-00385
    Event Type
    Other
    Date Received
    July 5, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO RECURRENT DISLOCATION. THE PARTS WERE REMOVED AND REPLACED; THE BASEPLATE AND 4.0 SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER GLENOID HA-COAT BASEPLATE KWS ENCORE MEDICAL, L.P. A1000020

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention 506-03-0138, LOT 54015582| 506-03-118, LOT A1000001| 506-03-118, LOT A1000001| 506-03-130, LOT 54057570