BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP SHOULDER SYSTEM

    MDR report key: 1061730 · Received June 16, 2008

    Report

    Report Number
    1644408-2008-00188
    Event Type
    Other
    Date Received
    June 16, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 22, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY -FRACTURE BELOW THE STEM (PERIPROSTHETIC FRACTURE). REMOVED OLD STEM AND PUT IN A LONGER REVISION STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER SYSTEM HUMERAL STEM HSD ENCORE MEDICAL, L.P. 53880894

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR 508-00-001