BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVATION

    MDR report key: 8949378 · Received August 30, 2019

    Report

    Report Number
    1038671-2019-00437
    Event Type
    Injury
    Date Received
    August 30, 2019
    Date of Event
    August 1, 2019
    Report Date
    December 13, 2019
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    PMA / PMN Number
    K070479
    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. HOWEVER, A NON-EXACTECH FEMORAL STEM WAS USED WITH EXACTECH ACETABULAR COMPONENTS. THIS IS CONSIDERED OFF-LABEL USE AND MAY HAVE CONTRIBUTED TO INCREASED WEAR OF THE ACETABULAR LINER DUE TO FEMORAL NECK IMPINGEMENT. IT IS UNCLEAR IS AN EXACTECH FEMORAL HEAD WAS IMPLANTED. CONCOMITANT MEDICAL DEVICE(S): (CN: 180-11-50, SN: (B)(4)) NV CROWN CUP CLSR HL W/HA 50 GROUP 1. (CN: 120-65-35, SN: (B)(4)) BONE SCREW 6.5MM DIA X 35MM LONG. (CN: 120-65-20, SN: (B)(4)) BONE SCREW 6.5MM DIA X 20MM LONG.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT MEDICAL DEVICE(S): (CN: 180-11-50, SN: (B)(4)) NV CROWN CUP CLSR HL W/HA 50 GROUP 1; (CN: 120-65-35, SN: (B)(4)) BONE SCREW 6.5MM DIA X 35MM LONG; (CN: 120-65-20, SN: (B)(4)) BONE SCREW 6.5MM DIA X 20MM LONG.

    Description of Event or Problem · 1

    PREMATURE WEAR OF POLYETHYLENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745059 NOVATION NV GXL LNR, LIPPED, 28MM ID, GROUP 1 CUPS JDI EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other