BEUDAMED
    FDA Adverse Event Other Summary report: N

    TURON SHOULDER

    MDR report key: 2011716 · Received March 1, 2011

    Report

    Report Number
    1644408-2011-00102
    Event Type
    Other
    Date Received
    March 1, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 14, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    PMA / PMN Number
    K080402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO A DEFICIENT ROTATOR CUFF; PT EXPERIENCED A PAINFUL AND UNSTABLE SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURON SHOULDER PRIMARY HUMERAL STEM KWS ENCORE MEDICAL, L.P. 53994288

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention 520-50-110, LOT 53995320| 520-00-000, LOT 54002425| 520-01-042, LOT 53992236