BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 17342815 · Received July 18, 2023

    Report

    Report Number
    1038671-2023-01692
    Event Type
    Injury
    Date Received
    July 18, 2023
    Date of Event
    June 26, 2023
    Report Date
    January 16, 2025
    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
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF PAIN AND FEMORAL STEM LOOSENING THAT OCCURRED OVER APPROXIMATELY 5 YEARS AND 6 MONTHS OF USE. THE STEM LOOSENING MAY HAVE BEEN THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE FEMORAL STEM AND THE FEMORAL BONE, WHICH LIKELY CONTRIBUTED TO THE REPORTED PAIN. HOWEVER, THIS CANNOT BE CONFIRMED FROM THE REPORTED INFORMATION AND THE DEVICES WERE NOT AVAILABLE FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF PAIN AND FEMORAL STEM LOOSENING THAT OCCURRED OVER APPROXIMATELY 5 YEARS AND 6 MONTHS OF USE. THE STEM LOOSENING MAY HAVE BEEN THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE FEMORAL STEM AND THE FEMORAL BONE, WHICH LIKELY CONTRIBUTED TO THE REPORTED PAIN. HOWEVER, THIS CANNOT BE CONFIRMED FROM THE REPORTED INFORMATION AND THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. H6: CORRECTED HEALTH EFFECT, MEDICAL DEVICE, AND INVESTIGATION CLINICAL CODES.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION. (D10) CONCOMITANT DEVICE(S): 4908847, 190-31-08 - ALT HA S CLR EXT SZ 8. 5098983, 186-01-54 - INTEGRIP CC, CLUSTER 54MM, G2. 5112757, 180-65-20 - ALTEON 6.5MM SCREW, 20MM. 5148241, 142-32-03 - COCR FEM HEAD 32MM +3.5 OFFSET 12/14.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 5.5 YEARS POST OP INITIAL LEFT THA, THIS 67 Y/O MALE PATIENT WAS REVISED. THE PATIENT WAS BROUGHT BACK FOR LEFT HIP PAIN. THE FEMUR WAS DISLOCATED AND THE FEMORAL HEAD REMOVED. STEM WAS LOOSE AND REMOVED. ATTENTION TURNED TO CUP. THE POLY WAS REMOVED WITH THE HELP OF A BONE SCREW. THE 6.5 X20MM BONE SCREW WAS REMOVED. THE CUP WAS CHECKED AND FOUND TO BE WELL FIXED. A NEW XLE G2 36MM LIPPED POLY WAS IMPLANTED. AN HPS STEM AND A 36+3.5 BIOLOX HEAD WAS IMPLANTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS OR PHOTOS PROVIDED, UNABLE TO OBTAIN. NO PRODUCT RETURN. PATIENT REQUESTED IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862204 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 67 YR Male