BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION SHOULDER

    MDR report key: 2163679 · Received June 15, 2011

    Report

    Report Number
    1644408-2011-00344
    Event Type
    Other
    Date Received
    June 15, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K003324
    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 PATIENT HAD A MASSIVE ROTATOR CUFF TEAR. THE DOCTOR REVISED TO A REVERSE TOTAL SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION SHOULDER PLASMA HUMERAL STEM, W/MALE TAPER KWS ENCORE MEDICAL, L.P. 53955894

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention