BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION SHOULDER SYSTEM

    MDR report key: 1001895 · Received February 25, 2008

    Report

    Report Number
    1644408-2008-00052
    Event Type
    Other
    Date Received
    February 25, 2008
    Date of Event
    January 26, 2008
    Report Date
    February 25, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - TOTAL SHOULDER REPLACEMENT 2008. EVAL THE NEXT MORNING SHOWED AN ANTERIOR DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION SHOULDER SYSTEM HUMERAL HEAD, OFFSET HSD ENCORE MEDICAL, L.P. 53834730

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention