BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP REVERSE SHOULDER SYSTEM

    MDR report key: 1040646 · Received May 7, 2008

    Report

    Report Number
    1644408-2008-00145
    Event Type
    Other
    Date Received
    May 7, 2008
    Date of Event
    April 11, 2008
    Report Date
    May 7, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - REVERSE SHOULDER FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP REVERSE SHOULDER SYSTEM GLENOID HEAD KWS ENCORE MEDICAL, L.P. 53804465

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention