BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINER LIPPED 36MM ID GROUP 2

    MDR report key: 18334370 · Received December 15, 2023

    Report

    Report Number
    1038671-2023-02992
    Event Type
    Injury
    Date Received
    December 15, 2023
    Date of Event
    November 28, 2023
    Report Date
    August 21, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    PMA / PMN Number
    K121392
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PENDING INVESTIGATION. D10: 2882996 - 160-30-13 - PF SPLINE PLASMA W/HA SZ 13 3645616 - 186-03-54 - INTEGRIP MH CUP SZ 54MM2 4149590 - 142-36-00 - COCR FEM HEAD 36MM +0 OFFSET 12/14 4154312 - 180-65-20 - ALTEON 6.5MM SCREW, 20MM 4192799 - 180-65-25 - ALTEON 6.5MM SCREW, 25MM 4193180 - 180-65-30 - ALTEON 6.5MM SCREW, 30MM H7: Z-2122-2021

    Additional Manufacturer Narrative · 0

    H3: BASED ON THE AVAILABLE INFORMATION, THE PATIENT INVOLVED MEETS THE FOLLOWING RISK CRITERIA FOR EARLY PROSTHESIS WEAR AND/OR OSTEOLYSIS AS SPECIFIED IN THE HHE: EDGE LOADING OF THE FEMORAL HEAD ON THE ACETABULAR LINER AND COMBINATION OF LARGEST AVAILABLE FEMORAL HEAD AND/OR THINNEST AVAILABLE ACETABULAR LINER WAS USED. THE MOST LIKELY CAUSE FOR THE REPORTED REVISION DUE TO PROSTHESIS WEAR IS A COMBINATION OF THE RISK FACTORS SPECIFIED IN THE HHE. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES WERE NOT PROVIDED. ADDITIONALLY, THE REPORTED WEAR COULD NOT BE DETERMINED FROM THE PROVIDED RADIOGRAPH. CORRECTION: H6 CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE, AND COMPONENT CODE.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL LEFT THA ON AN UNKNOWN DATE. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO THE RECALL, AND THE LINER WAS SWAPPED. 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
    2298822 NV GXL LINER LIPPED 36MM ID GROUP 2 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention SEE H10.