BEUDAMED
    FDA Adverse Event Death Summary report: N

    ELEOS

    MDR report key: 18534753 · Received January 18, 2024

    Report

    Report Number
    3013450937-2024-00012
    Event Type
    Death
    Date Received
    January 18, 2024
    Date of Event
    December 5, 2023
    Report Date
    March 18, 2024
    Manufacturer
    ONKOS SURGICAL
    Product Code
    KRO
    UDI-DI
    B278CB1515203M0
    PMA / PMN Number
    K161520
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE REVIEW OF DEVICE HISTORY RECORDS, THE INVESTIGATION CONCLUDED THAT THE ROOT CAUSE OF THIS ADVERSE EVENT WAS NOT RELATED TO THE DESIGN, MANUFACTURE, AND/OR STERILIZATION OF THE ELEOS DEVICES. THE INVESTIGATION CONCLUDED THAT INTRAOPERATIVE EMBOLISM IS A PROCEDURE-RELATED COMPLICATION AND IS UNRELATED TO THE DEVICE.

    Description of Event or Problem · 0

    CANCER PATIENT. PATIENT EXPERIENCED AN EMBOLISM IN CANAL AFTER STEM WAS CEMENTED IN FEMUR. THE PATIENT CRASHED AND PASSED AWAY ON THE TABLE DURING THE SURGERY.

    Description of Event or Problem · 0

    IT WAS REPORTED BY H. LEWIS, AN ONKOS SALES REPRESENTATIVE, THAT A FEMALE PATIENT IN HER 70'S TERMINALLY SUFFERED FROM AN INTRAOPERATIVE EMBOLISM DURING THE PRIMARY SURGERY TO IMPLANT AN ELEOS PROXIMAL FEMUR REPLACEMENT ON (B)(6) 2023. BONE CEMENT WAS UTILIZED TO FIXATE THE CEMENTED SEGMENTAL STEM IN THE PROXIMAL FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868776 ELEOS CEMENTED STEM BOWED KRO ONKOS SURGICAL 90762-005 B278CB1515203M0

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Death 32MM FEMORAL HEAD +3.5 COCR - PLANNED USE| ELEOS 40MM MIDSECTION - PLANNED USE| RIGHT PROXIMAL FEMUR SEGMENT - PLANNED USE