BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS

    MDR report key: 15877689 · Received November 29, 2022

    Report

    Report Number
    1038671-2022-01524
    Event Type
    Injury
    Date Received
    November 29, 2022
    Date of Event
    September 1, 2022
    Report Date
    May 1, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862207074
    PMA / PMN Number
    K121392
    Removal / Correction Number
    Z-1732-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: 5579081 142-32-93 - COCR FEM HEAD 32MM -3.5 OFFSET 12/14; S003693 180-65-20 - ALTEON 6.5MM SCREW, 20MM; 5797114 186-01-48 - INTEGRIP CC, CLUSTER 48MM, G1; 5259131 190-31-06 - ALT HA S CLR EXT SZ 6. CORRECTION/REMOVAL NUMBER: Z-1732-2022.

    Additional Manufacturer Narrative · 0

    THE MOST LIKELY CAUSE FOR THE REVISION REPORTED DUE TO PROSTHESIS WEAR IS A COMBINATION OF RISK FACTORS INCLUDING, USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS MAY HAVE ALSO BEEN A CONTRIBUTING FACTOR TO THE EARLY PROSTHESIS WEAR. HOWEVER, THIS CANNOT BE NOT CONFIRMED WITH THE INFORMATION PROVIDED; DEVICES WERE NOT RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 0

    AS REPORTED BY LEGAL, THE FEMALE PATIENT HAD A RIGHT THA ON (B)(6) 2019. THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO POLY WEAR AND ACETABULAR OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1672203 NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 130-32-51 10885862207074

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention