BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 17824267 · Received September 27, 2023

    Report

    Report Number
    1038671-2023-02383
    Event Type
    Injury
    Date Received
    September 27, 2023
    Date of Event
    February 7, 2023
    Report Date
    March 28, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862022233
    PMA / PMN Number
    K070479
    Removal / Correction Number
    Z-1729-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 2950504 180-01-56 - NV CROWN CUP CLSTR HOLE 56MM GROUP 3, 3691128 188-00-09 - WEDGE PLASMA S/O SZ 9, 3708422 180-65-25 - ALTEON 6.5MM SCREW, 25MM, 3958609 170-36-00 - BIOLOX DELTA FEMORAL HEAD 36MM OD, +0MM, PENDING INVESTIGATION.

    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 6 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 (B)(6) 2023. DIAGNOSIS: FAILED RIGHT TOTAL HIP. SEVERE POLYETHYLENE WEAR WITH SIGNS OF OXIDATION, PITTING AND DELAMINATION PRESENT. EXTENSIVE SOFT TISSUE DAMAGE TO THE SURROUNDING HIP SOFT TISSUES. PATIENT WAS REVERSED FROM ANESTHESIA AND MOVE ONTO THE HOSPITAL BED WITHOUT DIFFICULTY. PATIENT WAS TAKEN TO PACU IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019965 NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. UNK 10885862022233

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention