BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LNR, NEUTRAL, 32MM ID, GROUP 3 CUPS

    MDR report key: 19323304 · Received May 15, 2024

    Report

    Report Number
    1038671-2024-01267
    Event Type
    Injury
    Date Received
    May 15, 2024
    Date of Event
    April 26, 2024
    Report Date
    August 13, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862022172
    PMA / PMN Number
    K070479
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 5043256 180-01-56 - CROWN CUP,CLUSTER-HOLE.

    Additional Manufacturer Narrative · 0

    H3: THE MOST LIKELY CAUSE FOR THE REPORTED REVISION DUE TO PROSTHESIS WEAR AND OSTEOLYSIS COULD INCLUDE A NUMBER OF VARIABLES INCLUDING USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS (FITNESS FOR SURGERY, BIOMECHANICS, ACTIVITY LEVEL AND LOCAL TISSUE OXIDATION POTENTIAL). HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED.

    Description of Event or Problem · 0

    THE PATIENT PRESENTED FOR A CHECK-UP. IN THE X-RAY CONTROL, THERE WAS A CLEAR DECENTERING OF THE PROSTHESIS HEAD AND UNUSUALLY LARGE OSTEOLYSIS IN THE ACETABULUM, AS A SIGN OF INLAY WEAR. THIS WAS VERIFIED WHEN THE INLAY WAS CHANGED TO A VITD-HARDENED ONE, A SPECIALLY APPROVED INLAY (NOVATION XLE NEUTRAL LINER, GROUP 3, 36 MM, I.D., REF (B)(4), SN (B)(6)). AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY REPLACEMENT, THE FIRMNESS WAS DETERMINED, SOCKET INTEGRITY AND THE REPLACEMENT OF THE PROSTHETIC HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482933 NV GXL LNR, NEUTRAL, 32MM ID, GROUP 3 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 10885862022172

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention