BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 20824536 · Received December 2, 2024

    Report

    Report Number
    1038671-2024-04580
    Event Type
    Injury
    Date Received
    December 2, 2024
    Date of Event
    November 19, 2024
    Report Date
    November 6, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862022165
    PMA / PMN Number
    K070479
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANTS: 188-00-06 - WEDGE PLASMA S/O SZ 6, (B)(6). 170-32-00 - BIOLOX DELTA FEMORAL HEAD 32MM OD +0MM, (B)(6). 186-01-52 - INTEGRIP CC, CLUSTER 52MM, G2, (B)(6). 180-65-25 - ALTEON 6.5MM SCREW, 25MM, (B)(6). 180-65-25 - ALTEON 6.5MM SCREW, 25MM, (B)(6).

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT RECEIVED A HIP REPLACEMENT APPROXIMATELY 7 YEARS AND 4 MONTHS PRIOR TO THE REPORT AND THE PLASTIC LINER WAS DEFECTIVE. A REVISION WAS SCHEDULED BUT NOT YET PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333257 NOVATION NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 10885862022165

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention SEE H11.