BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS

    MDR report key: 17034823 · Received May 31, 2023

    Report

    Report Number
    1038671-2023-01189
    Event Type
    Injury
    Date Received
    May 31, 2023
    Date of Event
    August 26, 2022
    Report Date
    April 24, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    LZO
    UDI-DI
    10885862022066
    PMA / PMN Number
    K070479
    Removal / Correction Number
    Z-1729-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS PRODUCT INFORMATION: 3976742 188-01-03 - WEDGE PLASMA X/O SZ 3; 4060945 180-65-20 - ALTEON 6.5MM SCREW, 20MM; 4154646 170-28-00 - BIOLOX DELTA FEMORAL HEAD 28MM OD, +0MM; 4430397 180-65-20 - ALTEON 6.5MM SCREW, 20MM; 4635261 186-01-50 - INTEGRIP CC, CLUSTER 50MM, G1 UPDATED/ADDITIONAL INFORMATION ¿ A2. A3. D1. D4. D5. G1. G2. G4. H4. H6. H7. H9. 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 WAS IMPLANTED WITH AN EXACTECH DEVICE (B)(6) 2016. THEY WERE REVISED (B)(6) 2022, APPROXIMATELY 5 YEARS 8 MONTHS AFTER THEIR INITIAL PROCEDURE. 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
    490503 NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED UNK 10885862022066

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Hospitalization| R SEE H10