BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 2214076 · Received July 19, 2011

    Report

    Report Number
    1644408-2011-00407
    Event Type
    Other
    Date Received
    July 19, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 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 - THE PATIENT FAILED TO COMPLETE PHYSICAL THERAPY PER THE SURGEON. THE PATIENT EXPERIENCED TIGHTNESS IN THE JOINT. A SOCKET SHELL AND SOCKET INSERT WERE REPLACED. THERE WAS NO FAILURE WITH THE PRODUCT PER THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER STANDARD HUMERAL SOCKET INSERT KWS ENCORE MEDICAL, L.P. 54036088

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 508-00-004, LOT 53997585