BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION SHOULDER

    MDR report key: 1912757 · Received November 2, 2010

    Report

    Report Number
    1644408-2010-00588
    Event Type
    Other
    Date Received
    November 2, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSD
    PMA / PMN Number
    K950594
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT WAS DOING WELL FIVE YEARS POST-OP UNTIL SHE FELL AND INJURED HER ROTATOR CUFF. IT WAS DETERMINED SHE WOULD BE BETTER SERVED WITH A REVERSE SHOULDER PROSTHESIS AND WAS REVISED TO ONE AS PLANNED BY THE SURGEON.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention 500-04-146, LOT NA| 503-00-008, LOT NA