BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONNEXION GXL

    MDR report key: 17059288 · Received June 5, 2023

    Report

    Report Number
    1038671-2023-01234
    Event Type
    Injury
    Date Received
    June 5, 2023
    Date of Event
    August 3, 2022
    Report Date
    June 20, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    LZO
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS - THERE IS NO SPECIFIC CONNEXION GXL DEVICE INFORMATION PROVIDED. THE CAUSE OF THE PATIENT'S CONDITION AND REVISION SURGERY AS RELATED TO THE DEVICES CANNOT BE CONCLUSIVELY DETERMINED, INSUFFICIENT INFORMATION. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. THERE IS NO OTHER INFORMATION AVAILABLE. CORRECTIONS: D1 CONNEXION GXL. D2A LZO. D2B. PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED . D4 CAT # UNK.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT HIP REPLACEMENT ON (B)(6)2016. APPROXIMATELY 6 YEARS AND 8 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT HIP REVISION ON (B)(6)2022. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO INFORMATION ON THE SURGICAL PROCEDURE OR PATIENT OUTCOME. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1988297 CONNEXION GXL SEE H10 LZO EXACTECH, INC. CONNEXION GXL SELL SHEET UNK
    2293384 CONNEXION GXL SEE H10 LZO EXACTECH, INC. CONNEXION GXL SELL SHEET UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention