BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 2099467 · Received May 3, 2011

    Report

    Report Number
    1644408-2011-00255
    Event Type
    Other
    Date Received
    May 3, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 27, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT EXPERIENCED PAIN IN THE LEFT SHOULDER THAT APPEARED TO HAVE GRADE II SCAPULAR LAXITY. THE POLY COMPONENT SHOWED EXCESSIVE WEAR AND SPLITTING OF RIM. THE SURGEON REVISED THE SOCKET, GLENOID HEAD, BASEPLATE AND SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER HUMERAL NEUTRAL SOCKET KWS ENCORE MEDICAL, L.P. 996251

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 506-03-130, LOT 989651| 503-03-118, LOT 989591| 506-32-102, LOT 200722| 506-32-002, LOT 216332| 506-03-114, LOT 995101| 506-03-114, LOT 995101