BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEOS LIMB SALVAGE SYSTEM

    MDR report key: 20016623 · Received August 21, 2024

    Report

    Report Number
    3013450937-2024-00275
    Event Type
    Injury
    Date Received
    August 21, 2024
    Date of Event
    August 3, 2024
    Report Date
    August 16, 2024
    Manufacturer
    ONKOS SURGICAL
    Product Code
    KRO
    UDI-DI
    B278THSMWRS01M0
    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 ELEOS IMPLANTS

    Description of Event or Problem · 0

    IT WAS REPORTED BY S. STEINERT, AN ONKOS SALES REPRESENTATIVE, THAT A 76-YEAR-OLD FEMALE PATIENT WITH AN ELEOS DISTAL FEMUR REPLACEMENT UNDERWENT REVISION SURGERY ON (B)(6) 2024 DUE TO AN ALLEGED INFECTION. THE SURGEON, DOCTOR (B)(6, PERFORMED A POLY SWAP DURING THE WASHOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1117829 ELEOS LIMB SALVAGE SYSTEM TIBIAL ROTATIONAL HINGE KRO ONKOS SURGICAL 1956649 B278THSMWRS01M0

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention DISTAL FEMUR AXIAL PIN| TIBIAL POLY SPACER| TIBIAL ROTATIONAL HINGE