BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK FLUTED STEM EXTENSION

    MDR report key: 4173199 · Received September 19, 2014

    Report

    Report Number
    1038671-2014-00448
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 26, 2014
    Report Date
    September 16, 2014
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICES TO THE EXPERIENCE REPORTED COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    REVISION OF OPTETRAK KNEE COMPONENTS DUE TO TIBIAL LOOSENING. THIS EVENT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583062 OPTETRAK FLUTED STEM EXTENSION STEM EXTENSION JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization