BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVATION

    MDR report key: 19868120 · Received July 30, 2024

    Report

    Report Number
    1038671-2024-02602
    Event Type
    Injury
    Date Received
    July 30, 2024
    Date of Event
    April 3, 2024
    Report Date
    July 30, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    PMA / PMN Number
    K070479
    Removal / Correction Number
    Z-2127-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITTANT: 136-32-54 NV GXL LNR, +5 LAT 32MM ID, GROUP 4 CUPS 2900033. THE GXL LINER WAS REPORTED UNDER MDR# 1038671-2024-00817.

    Description of Event or Problem · 0

    AS PART OF THE MANUFACTURER'S RECALL CAMPAIGN, THE PATIENT PRESENTED FOR A CHECK-UP. THE X-RAY AND CT CHECK SHOWED A CLEAR DECENTERING OF THE PROSTHESIS HEAD AND UNUSUALLY LARGE OSTEOLYSIS IN THE PROSTHESIS ACETABULUM AS A SIGN OF INLAY WEAR. THIS COULD BE VERIFIED DURING THE JOINT REVISION. AS PART OF THE REPLACEMENT OPERATION, THE CYSTS IN THE SOCKET WERE CURETTAGE AND SEALED USING ALLOGENEIC MEANS, CANCELLOUS BONE AND DUE TO THE LOOSENING OF THE CUP, THE CHANGE TO A REVISION CUP WITH CHANGE OF THE PROSTHETIC HEAD (MRS-TITAN STANDARD, SIZE 64). THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR, OSTEOLYSIS, AND AN INSUFFICIENT BOND BETWEEN THE ACETABULAR CUP AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) ACETABULAR LOOSENING. BASED ON THE AVAILABLE INFORMATION, THE PATIENT INVOLVED IN MEETS THE FOLLOWING RISK CRITERIA FOR EARLY PROSTHESIS WEAR AND OSTEOLYSIS AS SPECIFIED IN THE HHE: IMPLANTED WITH A LATERALIZED LINER AND IMPLANTED WITH A COMPONENT HAVING A SHELF AGE OF GREATER THAN 2 YEARS. THE EXTENT AND ROOT CAUSE OF THE WEAR, OSTEOLYSIS, AND LOOSENING COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200162 NOVATION PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention