BEUDAMED
    FDA Adverse Event Other Summary report: N

    REVERSE SHOULDER SYSTEM

    MDR report key: 1080989 · Received July 23, 2008

    Report

    Report Number
    1644408-2008-00240
    Event Type
    Other
    Date Received
    July 23, 2008
    Date of Event
    July 9, 2008
    Report Date
    July 15, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY- PATIENT SUFFERED DISLOCATION OF RSP IMPLANT WITH NO SIGNIFICANT INJURY OR FALL REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVERSE SHOULDER SYSTEM HUMERAL SOCKET, SHELL KWS ENCORE MEDICAL, L.P. 53878226

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention 508-01-032