BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION SHOULDER

    MDR report key: 2001108 · Received February 16, 2011

    Report

    Report Number
    1644408-2011-00078
    Event Type
    Other
    Date Received
    February 16, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 7, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - TORN ROTATOR CUFF, THE SURGEON REMOVED A TOTAL SHOULDER PROSTHESIS AND IMPLANTED A REVERSE SHOULDER PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION SHOULDER PLASMA W/MALE TAPER HUMERAL STEM KWS ENCORE MEDICAL, L.P. 53993315

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention (B)(4), LOT 53897608| (B)(4), LOT 53984132| (B)(4), LOT 77/0927-10