BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GXL NUETRAL LINER, G0 28MM ID

    MDR report key: 19597333 · Received June 24, 2024

    Report

    Report Number
    1038671-2024-02090
    Event Type
    Injury
    Date Received
    June 24, 2024
    Date of Event
    January 12, 2024
    Report Date
    June 24, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862022059
    PMA / PMN Number
    K100269
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANT DEVICES: 2331372 148-28-93 - 12/14 ZIRCONIA HEAD 28MM -3.5MM NECK. 2376129 180-01-44 - CUP, CLUSTER-HOLE, 44MM GROUP 0. 2727925 160-01-12 - PF STEM TAPERED PLASMA EXT OFFSET SZ 12. 2821005 120-65-20 - BONE SCREW 6.5MM DIA X 20MM LONG. 2821109 120-65-20 - BONE SCREW 6.5MM DIA X 20MM LONG. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL, MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 122 MONTHS AFTER A LEFT TOTAL HIP REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, CATASTROPHIC POLY WEAR, THE POLY HAD BEEN WORN ALL THE WAY THROUGH AND CERAMIC/TITANIUM INTERFACE WAS MAKING AUDIBLE NOISE IN ADDITION TO PAIN. INITIAL SURGERY AND REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED WEAR OF THE IMPLANT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2194407 GXL NUETRAL LINER, G0 28MM ID PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 10885862022059

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention| H