BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEOS LIMB SALVAGE SYSTEM

    MDR report key: 20786864 · Received November 26, 2024

    Report

    Report Number
    3013450937-2024-00357
    Event Type
    Injury
    Date Received
    November 26, 2024
    Date of Event
    October 31, 2024
    Report Date
    November 26, 2024
    Manufacturer
    ONKOS SURGICAL
    Product Code
    KRO
    UDI-DI
    B27825002111E0
    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 POSSIBLE INFECTION WAS NOT RELATED TO THE DESIGN, MANUFACTURE, AND/OR STERILIZATION OF THE REVISED IMPLANTS

    Description of Event or Problem · 0

    IT WAS REPORTED BY L. WETZEL, AN ONKOS SALES REPRESENTATIVE, THAT A 54-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT A REVISION DUE TO AN ALLEGED PERI-OPERATIVE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2360119 ELEOS LIMB SALVAGE SYSTEM DISTAL FEMUR AXIAL PIN KRO ONKOS SURGICAL 1995173 B27825002111E0

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention DISTAL FEMUR| DISTAL FEMUR AXIAL PIN| MALE-FEMALE MIDSECTION| TIBIAL POLY SPACER| TIBIAL ROTATIONAL HINGE