BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS

    MDR report key: 19277375 · Received May 9, 2024

    Report

    Report Number
    1038671-2024-01144
    Event Type
    Injury
    Date Received
    May 9, 2024
    Date of Event
    November 21, 2023
    Report Date
    September 9, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862022233
    PMA / PMN Number
    K070479
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: 2554412 170-36-00 - BIOLOX DELTA FEMORAL HEAD 36MM OD, +0MM 3647919 164-02-13 - ELEMENT-STEM, COLLARLESS W/HA, HIGH OFFSET, SZ 13 4120441 186-03-56 - INTEGRIP MH CUP SZ 56MM THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO PHOTOGRAPHS OR X-RAYS 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

    H6: CORRECTED HEALTH EFFECT CLINICAL CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 95 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, PAIN, MILD SUBLUXATION, AND OSTEOLYSIS. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519598 NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 10885862022233

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention SEE H10