BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIS MOBILE LEG POSITIONER 2.0 FRAME

    MDR report key: 18854200 · Received March 7, 2024

    Report

    Report Number
    3005180920-2024-00102
    Event Type
    Malfunction
    Date Received
    March 7, 2024
    Date of Event
    February 13, 2024
    Report Date
    March 7, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    FWX
    UDI-DI
    07630040735773
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 21 FEBR 2024. LOT 1213764: (B)(4) ITEM MANUFACTURED AND RELEASED ON 23-JUL-2014. NO ANOMALIES FOUND RELATED TO THE PROBLEM. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT DURING PHA SURGERY ON A 96 YEAR OLD PATIENT, THE TIBIA FRACTURED ON THE DISTAL PART. ACCORDING TO REPORT, THE FRACTURE OCCURED DURING THE EXTERNAL ROTATION OF THE LEG WITH THE AMIS LEG POSITIONER. IT MAY BE POSSIBLE THAT DUE TO THE LOW BONE QUALITY OF THE PATIENT AND THE SMALL OVERALL DIMENSION OF THE TIBIA THE APPLIED TORTIONAL FORCE RESULTED EXCESSIVE.

    Description of Event or Problem · 0

    BONE FRACTURE OCCURRED DURING THE EXTERNAL ROTATION OF THE LEG WITH THE AMIS LEG POSITIONER. NO ADDITIONAL TREATMENT WAS PERFORMED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. (B)(6) YEAR-OLD PATIENT WITH POOR BONE QUALITY. IT IS UNKNOWN WHETHER OR NOT THE SURGEON WILL FIX THE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2195137 AMIS MOBILE LEG POSITIONER 2.0 FRAME HIP INSTRUMENT FWX MEDACTA INTERNATIONAL SA 1213764 07630040735773

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Female Other