BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 2170235 · Received July 5, 2011

    Report

    Report Number
    1644408-2011-00382
    Event Type
    Other
    Date Received
    July 5, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K051075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THERE WAS A FAILURE OF THE GLENOID IMPLANT. THE ENTIRE GLENOID ASSEMBLY WAS DISLODGED FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER GLENOID HA-COAT BASEPLATE KWS ENCORE MEDICAL, L.P. 53855982

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention 508-32-101, LOT 53851100| 506-03-118, LOT 53838940| 506-03-122, LOT 53854153