BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS

    MDR report key: 19344192 · Received May 17, 2024

    Report

    Report Number
    1038671-2024-01321
    Event Type
    Injury
    Date Received
    May 17, 2024
    Date of Event
    April 23, 2024
    Report Date
    September 3, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862207074
    PMA / PMN Number
    K121392
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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: 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 MOST LIKELY CAUSE FOR THE REPORTED REVISION DUE TO PROSTHESIS WEAR IS A COMBINATION OF THE RISK FACTORS SPECIFIED IN AN HHE. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (H6) HEALTH EFFECT - CLINICAL CODE.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 3536183 - 101-45-20 - 4.5MM DRILL BIT 20MM. 4644738 - 188-01-05 - WEDGE PLASMA X/O SZ 5. 4901074 - 170-32-00 - BIOLOX DELTA FEMORAL HEAD 32MM OD, +0MM 5140237 - 130-32-51 - NV GXL LINER. NEUTRAL, 32MM ID GROUP 1 CUPS 5976951 - 180-01-50 - NV CROWN CUP CLSTR HOLE 50MM GROUP 1. S038559 - 180-65-25 - ALTEON 6.5MM SCREW, 25MM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS FEMALE PATIENT'S LEFT HIP WAS REVISED APPROXIMATELY 4 YEARS 4 MONTHS POST OP DUE TO EARLY POLY WEAR. REVISED TO CROWN XLE POLY. FEMALE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNABLE TO OBTAIN PHOTOS/X-RAYS. PRODUCT NOT RETURNING - FACILITY WOULD NOT ALLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742411 NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 10885862207074

    Patients

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