BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ELBOW REPLACEMENT WITH FLEXI-HINGE

    MDR report key: 23097167 · Received September 19, 2025

    Report

    Report Number
    3013450937-2025-00229
    Event Type
    Injury
    Date Received
    September 19, 2025
    Manufacturer
    ONKOS SURGICAL
    Product Code
    KWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    IT WAS REPORTED THAT A REBUSHING WAS REQUESTED FOR THE IN-SITU TOTAL ELBOW REPLACEMENT WITH FLEXI-HINGE (PIN 19132).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1955738 TOTAL ELBOW REPLACEMENT WITH FLEXI-HINGE TOTAL ELBOW REPLACEMENT WITH FLEXI-HINGE KWJ ONKOS SURGICAL PIN 19132 PIN 19132

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization