BEUDAMED
    FDA Adverse Event Other Summary report: N

    TURON SHOULDER

    MDR report key: 3214089 · Received July 3, 2013

    Report

    Report Number
    1644408-2013-00357
    Event Type
    Other
    Date Received
    July 3, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K080402
    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 SUFFERED FROM ROTATOR CUFF AND REQUIRED A REVERSE SHOULDER PROSTHESIS. ALL IMPLANTS WERE REMOVED AND A REVERSE SHOULDER PROSTHESIS IMPLANT WAS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303846 TURON SHOULDER STANDARD HUMERAL HEAD KWS ENCORE MEDICAL, L.P. 54003844

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention 520-01-246, LOT 192G1013| 520-01-014, LOT 457G1000| 520-00-000, LOT 878C1161