BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEOS LIMB SALVAGE SYSTEM

    MDR report key: 23353322 · Received October 21, 2025

    Report

    Report Number
    3013450937-2025-00269
    Event Type
    Injury
    Date Received
    October 21, 2025
    Date of Event
    September 19, 2025
    Report Date
    October 21, 2025
    Manufacturer
    ONKOS SURGICAL INC.
    Product Code
    QZZ
    UDI-DI
    B278AMMS040MF0
    PMA / PMN Number
    K161520
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE OF THIS COMPLAINT WAS NOT DETERMINED. BASED ON THE REVIEW OF KNOWN DEVICE HISTORY RECORDS, THE INVESTIGATION CONCLUDED THAT THE ROOT CAUSE OF THE ALLEGED INFECTION WAS NOT RELATED TO THE DESIGN, MANUFACTURE, AND/OR STERILIZATION OF THE REVISED IMPLANTS. PRIMARY SURGERY WAS NOT DETERMINED, INFORMATION ON THE EXPLANTED DEVICE OF THE ELEOS PROXIMAL FEMUR WAS NOT IDENTIFIED. IF NEW INFORMATION IS INTRODUCED, A NEW REPORT WILL BE OPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY AN ONKOS SALES REPRESENTATIVE, THAT A 58-YEAR-OLD MALE PATIENT WITH ELEOS PROXIMAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. REPORTED THAT THE SURGEON SWAPPED MODULAR COMPONENTS. THIS REPORT CAPTURES THE ELEOS MALE-FEMALE MIDSECTION. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244040 ELEOS LIMB SALVAGE SYSTEM ELEOS NANOCEPT TECHNOLOGY ANTIBACTERIAL COATED MALE-FEMALE MIDSECTION SIZE 40MM QZZ ONKOS SURGICAL INC. J003376-003 B278AMMS040MF0

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention