BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVATION

    MDR report key: 8948261 · Received August 29, 2019

    Report

    Report Number
    1038671-2019-00430
    Event Type
    Injury
    Date Received
    August 29, 2019
    Date of Event
    August 1, 2019
    Report Date
    December 13, 2019
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    PMA / PMN Number
    K100269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ENGINEERING EVALUATION NOTED IN THE EXPERIENCE REPORTED THAT THE UNDERLYING CAUSE OF THE PROSTHESIS WEAR REPORTED CANNOT BE DETERMINED BECAUSE THE DEVICES HAVE NOT BEEN REVISED AND, THEREFORE, HAVE NOT BEEN RETURNED FOR EVALUATION. "EXCESSIVE WEAR OF THE IMPLANT COMPONENTS SECONDARY TO IMPINGEMENT OF COMPONENTS OR DAMAGE OF ARTICULAR SURFACES" IS LISTED IN THE PRODUCT LABELING UNDER DEVICE SPECIFIC RISKS. CONCOMITANT DEVICE(S): (CN: 164-01-13, SN: (B)(4)) ELEMENT-STEM, COLLARLESS W/HA, STD OFFSET, SZ 13. (CN: 140-28-00, SN: (B)(4)) 12/14 BIOLOX FEMORAL HD 28MM +0. (CN: 180-11-46, SN: (B)(4)) CUP CLUSTER-HOLE HA 46MM.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICE(S): (CN: 164-01-13, SN: (B)(4)) ELEMENT-STEM, COLLARLESS W/HA, STD OFFSET, SZ 13. (CN: 140-28-00, SN: (B)(4)) 12/14 BIOLOX FEMORAL HD 28MM +0. (CN: 180-11-46, SN: (B)(4)) CUP CLUSTER-HOLE HA 46MM.

    Description of Event or Problem · 1

    PREMATURE WEAR OF POLYETHYLENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741655 NOVATION NV GXL LIPPED LINER, G0 28MM ID JDI EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other