BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMIS MOBILE LEG POSITIONER 2.0 FRAME

    MDR report key: 19971649 · Received August 13, 2024

    Report

    Report Number
    3005180920-2024-00651
    Event Type
    Injury
    Date Received
    August 13, 2024
    Date of Event
    July 19, 2024
    Report Date
    August 13, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    FWX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 31 JULY 2024. LOT 2256032: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-FEB-2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRSDIRECTOR. AFTER SURGERY, THE SURGEON DISCOVERED A SPIRAL AND FIBULA FRACTURE AFTER REMOVING THE AMIS LEG POSITIONER. ACCORDING TO REPORT, THE 87-YEAR-OLD PATIENT HAD POOR BONE QUALITY, AND THIS IS DEFINITELY CONFIRMED QUALITATIVELY BY THE IMAGES SUPPLIED. FROM THE ASPECT OF THE FRACTURES, THE CAUSE SHOULD BE SOUGHT IN THE ROTATION PHASE OF THE LEG MOVEMENT DURING SURGERY, WITH ALL PROBABILITY. THE LEG POSITIONER DOES NOT PROTECT AGAINST ROTATIONAL FRACTURES, THEREFORE THE SAME CARE THAT WOULD BE USED IN HANDLING THE PATIENT'S LEG SHOULD BE USED ALSO WHEN MOVING THE LIMB TO EXPOSE THE FEMUR WITH THE LEG POSITIONER.

    Description of Event or Problem · 0

    SPIRAL AND FIBULA FRACTURE DISCOVERED AFTER REMOVING OF AMIS LEG POSITIONER AND CONFIRMED BY POST-OP X-RAYS. 87-YEAR-OLD PATIENT WITH POOR BONE QUALITY. THE TIMING OF THE FRACTURE IS UNKNOWN, ALTHOUGH IT IS SPECULATED THAT IT OCCURRED DURING EXTERNAL ROTATION OR AFTER EXTERNAL ROTATION AND EXTENSION. PLATE BONE FIXATION SURGERY PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1177098 AMIS MOBILE LEG POSITIONER 2.0 FRAME LEG POSITIONER FWX MEDACTA INTERNATIONAL SA 2256032

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Required Intervention