BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LNR, +5LAT, 36MM G2-52/54MM CUPS

    MDR report key: 24442043 · Received February 25, 2026

    Report

    Report Number
    1038671-2026-00179
    Event Type
    Injury
    Date Received
    February 25, 2026
    Date of Event
    February 5, 2026
    Report Date
    February 25, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862024329
    PMA / PMN Number
    K070479
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 142-36-00 - COCR FEM HEAD 36MM +0 OFFSET 12/14: 3829195. 160-30-12 - PF SPLINE PLASMA W/HA SZ 12: 3802410. 180-01-52 - NV CROWN CUP CLSTR HOLE 52MM GROUP 2: 3861908. 180-65-25 - ALTEON 6.5MM SCREW, 25MM: 3857829. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 10 YEARS AND 9 MONTHS POST THE INITIAL RIGHT TOTAL HIP ARTHROPLASTY, THE PATIENT REPORTED A GRINDING SENSATION IN THEIR HIP AND WAS REVISED DUE TO BEING UNSTABLE AND DISLOCATING POSTERIORLY. AN IMAGE PROVIDED SHOWS WEAR OF THE LINER. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR 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
    508938 NV GXL LNR, +5LAT, 36MM G2-52/54MM CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 10885862024329

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention| H SEE H11