BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LNR, +5LAT, 32MM G2-52/54MM CUPS

    MDR report key: 19329825 · Received May 16, 2024

    Report

    Report Number
    1038671-2024-01289
    Event Type
    Injury
    Date Received
    May 16, 2024
    Date of Event
    May 10, 2023
    Report Date
    September 5, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862024282
    PMA / PMN Number
    K070479
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANTS: 5200115 180-01-52 NV CROWN CUP CLSTR HOLE. FAT874 S&N (B)(6) NANOS FEMORAL NECK PROSTHESIS TI6AI4/TI-PLASMASPRAY/BONIT SIZE 6 CONE 12/14. 17JM13476 71343208 OXINIUM 32MM O.D., +8 12/14 TAPER FEMORAL HEAD ZR-2.5, NB. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO PHOTOGRAPHS WERE PROVIDED FOR REVIEW; THEREFORE THE REPORTED EVENT CANNOT BE CONFIRMED THROUGH ANALYSIS. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED BASED ON THE INFORMATION MADE AVAILABLE. SHOULD ADDITIONAL, RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF ACETABULAR LOOSENING, PROSTHESIS WEAR, AND OSTEOLYSIS. THE ASEPTIC (NON-INFECTED) LOOSENING WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE IMPLANT AND THE BONE. THE REPORTED WEAR AND OSTEOLYSIS MAY BE DUE TO A COMBINATION OF THE RISK FACTORS SPECIFIED IN THE HHE. ADDITIONALLY, A CONTRIBUTING FACTOR TO THE WEAR MAY HAVE BEEN THE OFF-LABEL USE DETAILED ABOVE. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE COMPONENTS WERE NOT RETURNED FOR EVALUATION, AND IMAGES OR RADIOGRAPHS WERE NOT PROVIDED. CORRECTIONS: H6 CLINICAL CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 61 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PAIN, POLYETHYLENE WEAR, AND DISLOCATION. WEAR WAS NOTED ON THE X-RAY, AND IT WAS CONFIRMED IN THE LEGAL DOCUMENTATION. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708026 NV GXL LNR, +5LAT, 32MM G2-52/54MM CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 10885862024282

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention SEE H10.