BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIP INSTRUMENTS

    MDR report key: 24762679 · Received April 2, 2026

    Report

    Report Number
    3005180920-2026-00302
    Event Type
    Injury
    Date Received
    April 2, 2026
    Date of Event
    March 13, 2026
    Report Date
    May 11, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    FWX
    UDI-DI
    07630040735773
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR THE ROOT CAUSE FOR ALL BONE FRACTURES IS THE APPLICATION OF FORCE OR TORQUE BEYOND THE MECHANICAL STRENGTH OF THE BONES. THE AMIS TABLE IS NOT EQUIPPED WITH A SYSTEM THAT PREVENTS EXCESSIVE FORCE TO BE APPLIED BECAUSE THIS FORCE IS EXTREMELY VARIABLE WITH INDIVIDUAL CONDITIONS, PARTICULARLY BONE DENSITY AND STRENGTH, AND CANNOT BE MEASURED IN ADVANCE. IT IS OF COURSE ALSO POSSIBLE THAT THE AMIS SHOE OR THE EXTENSION TABLE ITSELF WERE NOT PROPERLY PLACED ON THE PATIENT, BUT WE HAVE NO INFORMATION ON THIS POSSIBILITY AND THEREFORE WE ARE NOT CONSIDERING IT. THE MOST LIKELY REASON FOR THE FRACTURE IS THE APPLICATION OF EXCESSIVE FORCE OR TORQUE FOR THE INDIVIDUAL PATIENT. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICES COULD BE ASSOCIATED WITH THIS CASE. ROOT CAUSE:SPECIFIC PATIENT CONDITIONS AND UNIQUE SURGICAL FACTORS LIKELY RESULTED IN THE ISSUE REPORTED. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    AN INTRAOPERATIVE FRACTURE OCCURRED DURING USE OF AMIS LEG POSITIONER, WHEN THE FOOT IS EXTERNALLY ROTATED. THE SURGERY WAS COMPLETED SUCCESSFULLY, AND THE INTRAOPERATIVE FRACTURE WAS INITIALLY STABILIZED AND LATER DEFINITIVELY TREATED WITH PLATE FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24424 HIP INSTRUMENTS AMIS MOBILE LEG POSITIONER 2.0 FRAME FWX MEDACTA INTERNATIONAL SA 01.15.10.0190 1316299A 07630040735773

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other