BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS

    MDR report key: 17215414 · Received June 28, 2023

    Report

    Report Number
    1038671-2023-01479
    Event Type
    Injury
    Date Received
    June 28, 2023
    Date of Event
    July 25, 2023
    Report Date
    January 26, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862207074
    PMA / PMN Number
    K121392
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10. UPDATED/ADDITIONAL INFORMATION ¿ G1. G2. G4. H6. H8. 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. H11. CORRECTIONS ¿ D4.

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: (B)(6), 164-13-10 - NOVATION ELEMENT RO S/O COL SZ 10; (B)(6), 170-32-03 - BIOLOX DELTA FEMORAL HEAD 32MM OD, +3.5MM; (B)(6), 186-01-48 - INTEGRIP CC, CLUSTER 48MM, G1. PENDING INVESTIGATION.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT HIP REPLACEMENT ON (B)(6) 2017. APPROXIMATELY 5 YEARS AND 11 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAS A RIGHT HIP REVISION SCHEDULED ON (B)(6) 2023. THE PATIENT HAS EXPERIENCED DAILY PAIN AND DISCOMFORT IN HER RIGHT HIP WHICH HAS LIMITED HER ACTIVITIES OF DAILY LIVING AND IMPACTED HER QUALITY OF LIFE. THE PATIENT HAS SUFFERED DEBILITATING INJURIES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, PAIN AND DISCOMFORT; SWELLING; GAIT IMPAIRMENT; POOR BALANCE' AND OTHER INJURIES PRESENTLY UNDIAGNOSED, WHICH ALL REQUIRE ONGOING MEDICAL CARE. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. 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
    1725640 NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS UNK 10885862207074

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H10