BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVATION ELEMENT FEMORAL STEM

    MDR report key: 3863002 · Received June 6, 2014

    Report

    Report Number
    1038671-2014-00213
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    April 10, 2014
    Report Date
    June 5, 2014
    Manufacturer
    EXACTECH, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICES TO THE EXPERIENCE REPORTED COULD NOT BE DETERMINED AS THE DEVICE WERE NOT RETURNED FOR EVALUATION. ADDITIONALLY, THE DEVICE SPECIFIC IDENTIFICATION INFORMATION WAS NOT PROVIDED PRECLUDED A REVIEW OF THE DEVICE HISTORY RECORD.

    Description of Event or Problem · 1

    ANTERIOR FEMORAL CORTEX FRACTURE AFTER FEMORAL COMPONENT INSERTION. THIS EVENT WAS RECEIVED THOUGH CLINICAL DATA COLLECTION ACTIVITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331530 NOVATION ELEMENT FEMORAL STEM ELEMENT FEMORAL STEM LPH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R