BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEOS

    MDR report key: 22398392 · Received July 3, 2025

    Report

    Report Number
    3013450937-2025-00142
    Event Type
    Injury
    Date Received
    July 3, 2025
    Report Date
    July 3, 2025
    Manufacturer
    ONKOS SURGICAL
    Product Code
    KRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. AN INVESTIGATION OF THE DEVICE HISTORY RECORD AND POST-MARKET SURVEILLANCE HISTORY WAS COMPLETED AND NOTHING WAS FOUND. IF ADDITIONAL INFORMATION IS OBTAINED OR IF THE DEVICE IS RETURNED, A SUPPLEMENTAL MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    AN ALLEGED INFECTION WAS REPORTED FOR CUSTOM ELEOS DISTAL FEMORAL REPLACEMENT (C25-0034).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1934800 ELEOS CUSTOM ELEOS DISTAL FEMORAL REPLACEMENT KRO ONKOS SURGICAL C25-0034 C25-0034

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Hospitalization