BEUDAMED
    FDA Adverse Event Death Summary report: N

    NOVATION

    MDR report key: 8655100 · Received May 30, 2019

    Report

    Report Number
    1038671-2019-00301
    Event Type
    Death
    Date Received
    May 30, 2019
    Date of Event
    May 6, 2019
    Report Date
    August 30, 2019
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    PMA / PMN Number
    K070479
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE ENGINEERING EVALUATION NOTED THAT THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF THE ORIENTATION OF THE ACETABULAR CUP, EDGE LOADING/IMPINGEMENT, PATIENT CONDITIONS, OR A COMBINATION OF THE THREE, WHICH LED TO POLYETHYLENE WEAR AND OSTEOLYSIS. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE EXPLANTS WERE NOT RETURNED TO EXACTECH FOR EVALUATION. CONCOMITANT DEVICES: FEMORAL HEAD, 36+0 (CN: (B)(4) , LN: (B)(4). NOVATION CROWN CUP (CN: (B)(4), LN: (B)(4).

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT MEDICAL DEVICES: FEMORAL HEAD, 36+0 (CN: 142-36-00, LN: 52992002); NOVATION CROWN CUP (CN: 180-01-54, LN: 09256252).

    Description of Event or Problem · 1

    THE ORIGINAL DATE OF SURGERY FOR THIS PATIENT WAS 2015 (THE SURGEON DID NOT ELABORATE ON THE EXACT DATE THE PROSTHESIS WAS PUT IN). THE SURGEON CLAIMS IT IS CLASSICAL POLYETHYLENE WEAR LEADING TO SEVERE OSTEOLYSIS. PATIENT WAS STABLE AS THEY LEFT THE OPERATING ROOM. THE IMPLANTS WERE REMOVED INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448302 NOVATION NV GXL LNR, 10 DEG FACE, 36MM ID, GRP 2 CUP JDI EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention