BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 17736625 · Received September 13, 2023

    Report

    Report Number
    1038671-2023-02253
    Event Type
    Injury
    Date Received
    September 13, 2023
    Date of Event
    May 23, 2023
    Report Date
    April 24, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    LZO
    UDI-DI
    10885862207081
    PMA / PMN Number
    K121392
    Removal / Correction Number
    Z-1732-2022
    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

    PENDING INVESTIGATION. D10. CONCOMITANTS: 5140469 170-36-07 - BIOLOX DELTA FEMORAL HEAD 36MM OD, +7MM, 5112714 180-65-20 - ALTEON 6.5MM SCREW, 20MM, 5334436 180-65-30 - ALTEON 6.5MM SCREW, 30MM, 5071143 186-01-52 - INTEGRIP CC, CLUSTER 52MM G2, 4734934 188-01-07 - WEDGE PLASMA X/O SZ 7.

    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, A PATIENT HAD LEFT HIP REPLACEMENT SURGERY ON (B)(6)2018. THEY UNDERWENT LEFT HIP REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 5 YEARS POST PRIMARY PROCEDURE. REVISION OP REPORT NOTED SEVERE ADVERSE LOCAL TISSUE REACTION. THERE WAS DARK GRAY AND BLACK SYNOVITIS AND GREAT ABUNDANCE ALL THROUGHOUT THE JOINT. THE SURGEON PERFORMED AN ILIOPSOAS BURSECTOMY AND RELEASED THE ILIPSOAS TENDON. THERE WAS SOME MILD OSTEOLYSIS AROUND THE FEMORAL STEM, HOWEVER, THE TRUNNION WAS IN GOOD CONDITION AND THE STEM WAS WELL FIXED. THE SURGEON NOTED FINDING OSTEOLYSIS BEHIND THE POSTERIOR SCREW OF THE CUP AND SOME OSTEOLYSIS MEDIALLY. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475335 NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO EXACTECH, INC. UNK 10885862207081

    Patients

    Seq Age Sex Outcome Treatment
    1