BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVATION GXL

    MDR report key: 15414844 · Received September 13, 2022

    Report

    Report Number
    1038671-2022-01107
    Event Type
    Injury
    Date Received
    September 13, 2022
    Date of Event
    August 5, 2022
    Report Date
    December 30, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862207036
    PMA / PMN Number
    K121392
    Removal / Correction Number
    Z-1732-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    : NO DEVICE RETURN ANTICIPATED. LAWYER FOR THE PATIENT RETAINED THE DEVICES. CONCOMITANT MEDICAL PRODUCTS: 170-36-03, 4705628 - BIOLOX DELTA FEMORAL HEAD 36MM OD, +3.5MM, 180-65-25, 4992326 - ALTEON 6.5MM SCREW, 25MM, 186-01-52, 4973508- INTEGRIP CC, CLUSTER 52MM, G2, 188-01-07, 4896071 - WEDGE PLASMA X/O SZ 7. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    H6: BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF SURGICAL REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 77 YO MALE PATIENT, WHO HAD AN INITIAL GXL RIGHT HIP IMPLANTED ON (B)(6) 2017, HAD A PAINFUL RIGHT HIP AND WAS REVISED TO A XLE +5 LATERALIZED LINER AND +3.5 ADAPTER 36MM HEAD, ON (B)(6) 2022, APPROXIMATELY 4 YEARS 10 MONTHS POST THE INITIAL IMPLANT PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE PRODUCT IS NOT RETURNING - LAWYER WAS WAITING FOR THE IMPLANTS. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2673878 NOVATION GXL PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. NV GXL LINER LIPPED 36MM ID GROUP 2 UNK 10885862207036

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention| H SEE H10