BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN

    MDR report key: 2015757 · Received March 8, 2011

    Report

    Report Number
    1644408-2011-00125
    Event Type
    Other
    Date Received
    March 8, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO INFECTION STATUS POST COLON SURGERY. THE REP AND SURGEON DO NOT ATTRIBUTE THE REVISION TO FAILURE OF DJO PRODUCT. RATHER, A MODE OF FAILURE WAS OSTEOMYELITIS OF THE MEDIAL ACETABULUM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention