BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS

    MDR report key: 19274741 · Received May 8, 2024

    Report

    Report Number
    1038671-2024-01141
    Event Type
    Injury
    Date Received
    May 8, 2024
    Date of Event
    April 17, 2024
    Report Date
    October 17, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862207098
    PMA / PMN Number
    K121392
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 4569028 180-65-35 - ALTEON 6.5MM SCREW, 35MM 4895555 186-01-58 - INTEGRIP CC, CLUSTER 58MM, G3 4985970 170-40-03 - BIOLOX DELTA FEMORAL HEAD 40MM 0D, +3.5MM 5418807 188-01-10 - WEDGE PLASMA X/O SZ 10.

    Description of Event or Problem · 0

    AS REPORTED, THE 64 YEAR OLD MALE PATIENT HAD AN INITIAL RIGHT THA ON (B)(6) 2018. THE PATIENT UNDERWENT A REVISION ON AN UNKNOWN DATE AND THE SURGEON REMOVED THE HEAD AND THEN THE LINER, WHICH WAS IN PIECES (AS SHOWN IN PHOTOS). HE THEN IMPLANTED A NEW G3 XLE LINER AND A 40+7 BIOLOX OPTIONS HEAD. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470627 NV GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 10885862207098

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention