BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINR, NTRL, 36MM ID, GROUP 5 CUPS

    MDR report key: 17603822 · Received August 23, 2023

    Report

    Report Number
    1038671-2023-02025
    Event Type
    Injury
    Date Received
    August 23, 2023
    Date of Event
    June 19, 2023
    Report Date
    April 30, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    LZO
    UDI-DI
    10885862022257
    PMA / PMN Number
    K070479
    Removal / Correction Number
    Z-1729-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: 2410124 120-65-30 - BONE SCREW 6.5MM DIA X 30MM LONG, 2284069 148-36-93 - 12/14 ZIRCONIA HEAD 36MM REP BY 170-36-93, 2410380 164-01-12 - ELEMENT-STEM, COLLARLESS W/HA, STD OFFSET, SZ 12, 1182377 180-01-64 - NV CROWN CUP CLSTR HOLE 64MM GROUP 5.

    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 RIGHT HIP REPLACEMENT SURGERY ON (B)(6) 2012. THEY UNDERWENT RIGHT HIP REVISION SURGERY ON (B)(6) 2023, APPROXIMATELY 10 YEARS 10 MONTHS POST PRIMARY PROCEDURE. (B)(6) 2023 OP REPORT POSTOPERATIVE DIAGNOSIS: RIGHT HIP OSTEOLYSIS FOLLOWING TOTAL HIP ARTHROPLASTY. 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
    1496206 NV GXL LINR, NTRL, 36MM ID, GROUP 5 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO EXACTECH, INC. UNK 10885862022257

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention SEE H10