BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR FEMORAL HEAD

    MDR report key: 3854888 · Received May 23, 2014

    Report

    Report Number
    1038671-2014-00177
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 23, 2014
    Manufacturer
    EXACTECH, INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING EVAL PENDING RETURN OF THE DEVICE.

    Description of Event or Problem · 1

    FOUR YEARS POST OP: REVISION PERFORMED DUE TO POSSIBLE INFECTION. POLY WEAR WAS NOTED ON THE POLYETHYLENE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309132 COCR FEMORAL HEAD COCR FEMORAL HEAD LZO EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R