BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVATION

    MDR report key: 3143225 · Received May 28, 2013

    Report

    Report Number
    1038671-2013-00047
    Event Type
    Other
    Date Received
    May 28, 2013
    Date of Event
    July 9, 2012
    Report Date
    May 28, 2013
    Manufacturer
    EXACTECH INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING EVALUATION OF THE RETURNED DEVICE IS ONGOING.

    Description of Event or Problem · 1

    REVISION OF HIP COMPONENTS DUE TO WEAR AND OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233401 NOVATION GXL LINER LPH EXACTECH INC. 2162086

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention