BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER

    MDR report key: 2111206 · Received May 26, 2011

    Report

    Report Number
    1644408-2011-00305
    Event Type
    Other
    Date Received
    May 26, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE GLENOSPHERE SEPARATED FROM THE BASEPLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER GLENOID HEAD W/RETAINING SCREW, NEUTRAL KWS ENCORE MEDICAL, L.P. 869C1021

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention 508-00-036, LOT 8561010