BEUDAMED
    FDA Adverse Event Other Summary report: N

    TURON SHOULDER

    MDR report key: 2222602 · Received August 16, 2011

    Report

    Report Number
    1644408-2011-00459
    Event Type
    Other
    Date Received
    August 16, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K080402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - ON THE ORIGINAL SURGERY THE DOCTOR PUT IN A HEMI SHOULDER AND PUT BONE GRAFT ON THE GLENOID AS A TEMPORARY. AFTER IT HEALED, THE DOCTOR PUT IN A TOTAL REVERSE ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURON SHOULDER STANDARD HUMERAL HEAD KWS ENCORE MEDICAL, L.P. 53990648

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention