BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN

    MDR report key: 2170224 · Received July 5, 2011

    Report

    Report Number
    1644408-2011-00375
    Event Type
    Other
    Date Received
    July 5, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE REVERSE SHOULDER HUMERAL SHELL COMPONENT BECAME DETACHED FROM THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN GLENOID HOODED HEAD KWS ENCORE MEDICAL, L.P. RD0112

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention 506-03122, LOT 989611| 506-32,104, LOT 202822| 506-03-118, LOT 989601| 507-06-175, LOT 873871| 506-32-104, LOT RD0411