BEUDAMED
    FDA Adverse Event Summary report: N

    OPTETRACK TIBIAL INSERT

    MDR report key: 1240806 · Received November 14, 2008

    Report

    Report Number
    1038671-2008-00062
    Date Received
    November 14, 2008
    Report Date
    November 14, 2008
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE UNDERGOING ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    REVISION OF TKA DUE TO TIBIAL LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTETRACK TIBIAL INSERT TIBIAL INSERT HSH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R