BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVATION

    MDR report key: 8565892 · Received April 30, 2019

    Report

    Report Number
    1038671-2019-00266
    Event Type
    Injury
    Date Received
    April 30, 2019
    Date of Event
    April 30, 2019
    Report Date
    June 23, 2019
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    PMA / PMN Number
    K121392
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED IN THE EXPERIENCE WAS LIKELY THE RESULT OF EDGE LOADING CAUSED BY FEMORAL NECK IMPINGEMENT, WHICH LED TO ECCENTRIC WEAR OF THE ACETABULAR LINER. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT DEVICE: BIOLOX HEAD, 36MM, +0.

    Description of Event or Problem · 1

    HEAD AND LINER EXCHANGED DUE TO ECCENTRIC WEAR OF GXE POLY G2 36MM NEUTRAL. REVISING SURGEON NOTED OSTEOLYSIS ROUND THE RIM OF THE CUP AND PROXIMAL FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358389 NOVATION NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS JDI EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention