BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MY3D PERSONALIZED SOLUTIONS

    MDR report key: 23751942 · Received December 8, 2025

    Report

    Report Number
    3013450937-2025-00399
    Event Type
    Injury
    Date Received
    December 8, 2025
    Report Date
    December 8, 2025
    Manufacturer
    ONKOS SURGICAL
    Product Code
    KRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS COMMUNICATED THAT THE SURGEON HAD DIFFICULTY WITH EXPOSURE DUE TO EXCESS SOFT TISSUE. AS A RESULT OF THE LIMITED EXPOSURE AREA, THE SURGEON HAD DIFFICULTY IMPACTING THE FEMORAL STEM INTO THE PATIENT AND IMPACTING THE TAPER. DURING THE PATIENT'S POST OPERATIVE FOLLOW UP X-RAY, APPROXIMATELY 20 DAYS AFTER THE PROCEDURE, IT WAS IDENTIFIED THAT THE TAPER WAS NOT FULLY ENGAGED. BASED ON CONVERSATION WITH THE FIELD REPRESENTATIVE, IT WAS RELAYED THAT THE PATIENT THEN UNDERWENT AN ADDITIONAL PROCEDURE (B)(6) 2025 TO IMPACT THE TAPER. NO ONKOS DEVICES WERE REMOVED/REPLACED DURING THIS PROCEDURE. THE SECOND PROCEDURE HAD GONE SUCCESSFULLY, AS THE TAPER WAS ABLE TO BE LOCKED AFTER IMPACTION. PRODUCTION RECORDS WERE REVIEWED FOR PART C24-0850-0001, AND NO ISSUES WERE IDENTIFIED WHICH COULD HAVE CONTRIBUTED TO THE EVENT. THE PATIENT UNDERWENT A SECOND PROCEDURE TO ADDRESS THE TAPER DISSOCIATION. DURING THE SECOND PROCEDURE, THE TAPER WAS RE-IMPACTED AND LOCKED AS INTENDED. THERE WERE NO REPORTED ISSUES DURING THIS SECOND PROCEDURE. BASED ON THE AVAILABLE INFORMATION, IT IS POSSIBLE THAT TAPER LOCK WAS NOT ACHIEVED DURING THE INITIAL PROCEDURE DUE TO THE INTRA-OPERATIVE DIFFICULTY EXPERIENCED BY THE SURGEON DUE TO THE PATIENT'S EXPOSURE AREA/ EXCESS SOFT TISSUE. HOWEVER, A ROOT CAUSE COULD NOT BE ESTABLISHED CONCLUSIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH AN ONKOS SURGICAL CUSTOM FEMORAL STEM EXPERIENCED TAPER DISSOCIATION, WHICH WAS IDENTIFIED DURING THE PATIENT'S POST-OPERATIVE FOLLOW UP, APPROXIMATELY 20 DAYS AFTER THE INITIAL PROCEDURE. THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE TO ADDRESS THE DISSASSOCIATION; THE TAPER WAS REIMPACTED. NO ONKOS DEVICES WERE REMOVED OR REPLACED. THE ADDITIONAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE CUSTOM FEMORAL STEM WAS IMPLANTED AS INTENDED. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE ADDITIONAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2007738 MY3D PERSONALIZED SOLUTIONS CUSTOM FEMORAL STEM KRO ONKOS SURGICAL C24-0850-0001 C24-0850

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Female Required Intervention