BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN

    MDR report key: 2170121 · Received June 22, 2011

    Report

    Report Number
    1644408-2011-00356
    Event Type
    Other
    Date Received
    June 22, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 13, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO A MILD INFECTION, THE SURGEON REPLACED THE GLENOID, SOCKET, AND SHELL. AN I AND D WASHOUT WAS PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention