BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEOS LIMB SALVAGE SYSTEM

    MDR report key: 19711359 · Received July 10, 2024

    Report

    Report Number
    3013450937-2024-00226
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    June 28, 2024
    Report Date
    July 10, 2024
    Manufacturer
    ONKOS SURGICAL
    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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY J. ELLINTHORPE, AN ONKOS SALES REPRESENTATIVE, THAT A 68-YEAR-OLD MALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY DUE TO LOOSENING OF THE FEMORAL STEM. THE REVISION TOO PLACE ON (B)(6) 2024 AND WAS PERFORMED BY DOCTOR (B)(6) HOSPITAL IN (B)(6) CA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366815 ELEOS LIMB SALVAGE SYSTEM FEMORAL STEM KRO ONKOS SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention FEMORAL STEM.