BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LNR, +5 LAT 32MM ID, GROUP 3 CUPS

    MDR report key: 17859731 · Received October 3, 2023

    Report

    Report Number
    1038671-2023-02439
    Event Type
    Injury
    Date Received
    October 3, 2023
    Date of Event
    September 7, 2023
    Report Date
    January 24, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862024299
    PMA / PMN Number
    K070479
    Removal / Correction Number
    Z-1729-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10:(H3) PENDING EVALUATION.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE PATIENT/GXL ACETABULAR LINER INVOLVED WAS REPORTEDLY REVISED DUE TO EARLY PROSTHESIS WEAR AND OSTEOLYSIS APPROXIMATELY 5 YEARS AFTER THE INDEX SURGERY. HOWEVER, THE REVISED COMPONENTS WERE NOT RETURNED TO EXACTECH FOR EVALUATION AND NO IMAGES OR RADIOGRAPHS WERE PROVIDED. BASED ON THE AVAILABLE INFORMATION, THE PATIENT INVOLVED MEETS THE FOLLOWING RISK CRITERIA FOR EARLY PROSTHESIS WEAR AS SPECIFIED IN THE HHE: IMPLANTED WITH A LATERALIZED LINER. THE MOST LIKELY UNDERLYING CAUSE FOR THE REVISION DUE TO EARLY PROSTHESIS WEAR REPORTED IS A COMBINATION OF RISK FACTORS SPECIFIED IN AN HHE. HOWEVER, THIS CANNOT BE CONFIRMED FROM THE REPORTED INFORMATION AND THE DEVICES WERE NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    AS REPORTED, DUE TO THE MANUFACTURER'S RECALL CAMPAIGN, THE PATIENT THAT IS 5 YRS POSTOP THE INITIAL THAT CAME IN TO HAVE THE HIP PROSTHESIS CHECKED. X-RAY CONTROL REVEALED A CLEAR DECENTERING OF THE PROSTHETIC HEAD AND UNUSUALLY COARSE OSTEOLYSIS IN THE ACETABULUM AS SIGNS OF PREMATURE INLAY DETERIORATION. DIAGNOSIS THAT LED TO THE IMPLANTATION: PRIMARY COXARTHROSIS DURING THE REPLACEMENT OPERATION, THE SOCKET COMPONENT WAS COMPLETELY LOOSENED, SO THAT AFTER REMOVAL OF THE OLD CUP, SPA FIXATION AND SEALING, AND A COMPETITOR¿S DEVICES WERE IMPLANTED. DEVICE MAY BE RETURNED UPON POSSIBLE PATIENT CONSENT. SURGICAL REPORTS/X-RAYS ARE ALSO MADE AVAILABLE ON REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467003 NV GXL LNR, +5 LAT 32MM ID, GROUP 3 CUPS `PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. UNK UNK 10885862024299

    Patients

    Seq Age Sex Outcome Treatment
    1 Male