BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINR, NTRL, 36MM ID, GROUP 4 CUPS

    MDR report key: 18730241 · Received February 19, 2024

    Report

    Report Number
    1038671-2024-00253
    Event Type
    Injury
    Date Received
    February 19, 2024
    Date of Event
    March 7, 2023
    Report Date
    December 11, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862022240
    PMA / PMN Number
    K070479
    Removal / Correction Number
    Z-1729-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 4119788 170-36-03 - BIOLOX DELTA FEMORAL HEAD 36MM OD, +3.5MM 3521836 180-01-60 - NV CROWN CUP CLSTR HOLE 60MM GROUP 4 4063661 180-65-25 - ALTEON 6.5MM SCREW, 25MM 4121164 180-65-25 - ALTEON 6.5MM SCREW, 25MM 3684611 188-00-14 - WEDGE PLASMA S/O SZ 14 PENDING INVESTIGATION

    Additional Manufacturer Narrative · 0

    THE MOST LIKELY CAUSE FOR THE REVISION REPORTED DUE TO PROSTHESIS WEAR IS A COMBINATION OF RISK FACTORS INCLUDING, USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS MAY HAVE ALSO BEEN A CONTRIBUTING FACTOR TO THE EARLY PROSTHESIS WEAR. HOWEVER, THIS CANNOT BE NOT CONFIRMED WITH THE INFORMATION PROVIDED; DEVICES WERE NOT RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT HIP REPLACEMENT ON (B)(6) 2015. APPROXIMATELY 7 YEARS AND 5 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT HIP REVISION ON (B)(6) 2023. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. REVISION OP REPORT ON 7 MAR 2023 DIAGNOSIS: FAILED RIGHT HIP REPLACEMENT THE SURGEON COULD EASILY SEE A FAIRLY LARGE PSEUDOTUMOR EMERGING FROM THE JOINT AND EXTENDING UP INTO THE WATSON-JONES INTERVAL. IT WAS A BROWN, LIGHT-BROWNISH, GRAY BLAND APPEARING SEPSIS, HAD A TYPICAL APPEARANCE OF A PSEUDOTUMOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2092138 NV GXL LINR, NTRL, 36MM ID, GROUP 4 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. UNK 10885862022240

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Unknown Required Intervention| H SEE H10.