BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS

    MDR report key: 15051376 · Received July 19, 2022

    Report

    Report Number
    1038671-2022-00807
    Event Type
    Injury
    Date Received
    July 19, 2022
    Date of Event
    June 20, 2022
    Report Date
    January 25, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862207081
    PMA / PMN Number
    K121392
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING PRODUCT EVALUATION. CONCOMITANT MEDICAL PRODUCTS: 170-36-03 - BIOLOX DELTA FEMORAL HEAD 36MM OD, +3.5MM 4373958; 190-20-06 - ALT HA S NOCLR STD SZ 6 4916452.

    Additional Manufacturer Narrative · 0

    H3: BASED ON THE AVAILABLE INFORMATION, THE PATIENT INVOLVED IN MEETS THE FOLLOWING RISK CRITERIA FOR PROSTHESIS WEAR AS SPECIFIED: EDGE LOADING OF THE FEMORAL HEAD ON THE ACETABULAR LINER, COMBINATION OF LARGEST AVAILABLE FEMORAL HEAD AND/OR THINNEST AVAILABLE ACETABULAR LINER WAS USED, AND IMPLANTED WITH A COMPONENT HAVING A SHELF AGE OF GREATER THAN 2 YEARS. THE REVISION REPORTED WAS LIKELY THE RESULT OF A COMBINATION OF THE RISK FACTORS SPECIFIED. CORRECTIONAL/REMOVAL NUMBER: Z-2118-2021.

    Description of Event or Problem · 0

    AS REPORTED, THIS 64 YEAR OLD, MALE PATIENT HAD A RIGHT THA ON (B)(6) 2017. THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO WEAR OF THE G2 36MM GXL LINER, AND A G2 36MM GXE LINER WAS PUT IN. THERE IS NO REPORTED BREAKAGE OF THE 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
    1528067 NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 130-36-52 10885862207081

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male