BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS

    MDR report key: 19961414 · Received August 12, 2024

    Report

    Report Number
    1038671-2024-02780
    Event Type
    Injury
    Date Received
    August 12, 2024
    Date of Event
    August 1, 2024
    Report Date
    November 8, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862207074
    PMA / PMN Number
    K121392
    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.

    Additional Manufacturer Narrative · 0

    H3: BASED ON THE AVAILABLE INFORMATION, THE PATIENT INVOLVED MEETS THE FOLLOWING RISK CRITERIA FOR EARLY PROSTHESIS WEAR AND/OR OSTEOLYSIS AS SPECIFIED IN THE HHE: COMBINATION OF LARGEST AVAILABLE FEMORAL HEAD AND/OR THINNEST AVAILABLE ACETABULAR LINER WAS USED, AND IMPLANTED WITH A COMPONENT HAVING A SHELF AGE OF GREATER THAN 2 YEARS. THE MOST LIKELY CAUSE FOR THE REPORTED REVISION DUE TO PROSTHESIS WEAR AND OSTEOLYSIS IS A COMBINATION OF THE RISK FACTORS SPECIFIED IN THE HHE. 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 HAD A HIP PROSTHESIS CUP FROM EXACTECH IMPLANTED. AS PART OF THE MANUFACTURER'S RECALL, THE PATIENT CAME IN FOR A CHECK-UP. THE X-RAY AND CT SCANS SHOWED A CLEAR DECENTRATION OF THE PROSTHESIS HEAD AND UNUSUALLY LARGE OSTEOLYSES IN THE ACETABULUM AS SIGNS OF INLAY WEAR. THIS WAS VERIFIED WHEN THE INLAY WAS CHANGED TO A VIT E-HARDENED, SPECIALLY APPROVED INLAY (NOVATION XLE NEUTRAL LINER, GROUP 1, 32 MM I.D., REF 140-32-51, SN (B)(6)). AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY EXCHANGE, THE FIRM CUP INTEGRITY WAS DETERMINED, AS WELL AS THE CURETTAGE AND FILLING OF THE CYSTS IN THE CUP BED USING HYDROXYAPATITE + CALCIUM (BONE VOID FILLER) AND THE PROSTHESIS HEAD WAS CHANGED. DIAGNOSIS THAT LED TO IMPLANTATION: PRIMARY COXARTHROSIS M16.1 IMPLANTING CLINIC: (B)(6). PRODUCT IMPLANTED DURING REVISION ON (B)(6) 2024. 140-32-51 CC INLAY VITAMIN E, NEUTRAL, Ø 32, GR. 1 A455512. POLYETHYLENE WEAR: 4966378 130-32-51 - CROWN CUP INLAY PE, NEUT Ø 48-50, Ø 32. *THE SERIAL NUMBER (B)(6) IS AFFECTED BY THE RECALL* UDI: (B)(4). 510K: K121392. PRO CODE: JDI. CONCOMITANT: (B)(6) 180-01-48 - CROWN CUP,CLUSTER-HOLE GR.48.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1723724 NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 10885862207074

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention (B)(6) 180-01-48 - CROWN CUP,CLUSTER-HOLE GR.48.