BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION SHOULDER

    MDR report key: 2170116 · Received June 22, 2011

    Report

    Report Number
    1644408-2011-00352
    Event Type
    Other
    Date Received
    June 22, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    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 - DURING THERAPY, THE PT TORE HER ROTATOR CUFF BEYOND REPAIR. THE DR REVISED HER TO A REVERSE TOTAL SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION SHOULDER STANDARD HUMERAL HEAD KWS ENCORE MEDICAL, L.P. 53988059

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention 500-04-142, LOT# 54007041| 503-00-008, LOT# 53995317