BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 2214039 · Received August 2, 2011

    Report

    Report Number
    1644408-2011-00430
    Event Type
    Other
    Date Received
    August 2, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE RSP WAS DISLOCATING DURING PHYSICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER HUMERAL SOCKET SHELL, NEUTRAL KWS ENCORE MEDICAL, L.P. 848C1075

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention 508-00-032, LOT 855C1039| 508-32-101, LOT 862C1037