BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS

    MDR report key: 17920586 · Received October 12, 2023

    Report

    Report Number
    1038671-2023-02516
    Event Type
    Injury
    Date Received
    October 12, 2023
    Date of Event
    September 27, 2023
    Report Date
    December 12, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862022165
    PMA / PMN Number
    K070479
    Removal / Correction Number
    Z-1729-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) BASED ON THE AVAILABLE INFORMATION, THE PATIENT INVOLVED MEETS THE FOLLOWING RISK CRITERIA FOR EARLY PROSTHESIS WEAR AND OSTEOLYSIS AS SPECIFIED IN THE HHE: IMPLANTED WITH A COMPONENT HAVING A SHELF AGE OF GREATER THAN 2 YEARS. THE MOST LIKELY CAUSE FOR THE REVISION REPORTED DUE TO EARLY PROSTHESIS WEAR AND OSTEOLYSIS IS A COMBINATION OF THE RISK FACTORS SPECIFIED IN (B)(6). HOWEVER, THIS CANNOT BE CONFIRMED FROM THE REPORTED INFORMATION AND THE DEVICES, IMAGES, AND RADIOGRAPHS WERE NOT AVAILABLE FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION. (D10) CONCOMITANT DEVICE(S): 2943052, 180-01-54 - CROWN CUP,CLUSTER-HOLE GR.54.

    Description of Event or Problem · 0

    AS REPORTED, AS PART OF THE MANUFACTURER'S RECALL CAMPAIGN, THE 82 Y/O MALE PATIENT PRESENTED HIMSELF FOR A CHECK-UP OF THE DEVICE IMPLANTED IN 2014 HIP PROSTHESIS. THE X-RAY CONTROL SHOWED A CLEAR DECENTERING OF THE PROSTHETIC HEAD AND EXCEPTIONALLY LARGE OSTEOLYSIS IN THE ACETABULUM AND GREATER TROCHANTER AS A SIGN OF INLAY WEAR. THIS WAS POSSIBLE WHEN THE INLAY WAS CHANGED ON (B)(6) 2023 TO A VITD-HARDENED, SPECIALLY APPROVED INLAY (NOVATION XLE, EXTENDED COVERAGE LINER, SN (B)(6), REF 142-32-62). AS PART OF THE REPLACEMENT OPERATION, IN ADDITION TO THE INLAY EXCHANGE, THE SOLID INTEGRITY OF THE SOCKET WAS DETERMINED, AND THE CYST WAS REFLECTED ACETABULUM, CURETTAGE AND FILLING OF THE CYSTS IN THE SOCKET USING ALLOGENEIC SPONGIOSA AND THE CHANGING THE PROSTHETIC HEAD. DEVICES ARE AVAILABLE FOR RETURN AFTER INTERNAL INVESTIGATION. SURGICAL REPORTS/X-RAYS ARE ALSO AVAILABLE UPON REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1285686 NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. UNK UNK 10885862022165

    Patients

    Seq Age Sex Outcome Treatment
    1 Male