BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEOS LIMB SALVAGE SYSTEM

    MDR report key: 22469718 · Received July 10, 2025

    Report

    Report Number
    3013450937-2025-00145
    Event Type
    Injury
    Date Received
    July 10, 2025
    Date of Event
    June 26, 2025
    Report Date
    July 10, 2025
    Manufacturer
    ONKOS SURGICAL INC.
    Product Code
    KRO
    PMA / PMN Number
    K161520
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH AN ELEOS PROXIMAL FEMURE REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES THE ELEOS FEMORAL HEAD. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317618 ELEOS LIMB SALVAGE SYSTEM FEMORAL HEAD KRO ONKOS SURGICAL INC. 1997012

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention