BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER SYSTEM

    MDR report key: 1202864 · Received October 17, 2008

    Report

    Report Number
    1644408-2008-00370
    Event Type
    Other
    Date Received
    October 17, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 1, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSD
    PMA / PMN Number
    K041066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - PATIENT DISLOCATED. SURGEON RE-TRIALED AND PUT NEW CUP IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER SYSTEM SOCKET, SHELL, NEUTRAL HSD ENCORE MEDICAL, L.P. 53917074

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention