BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMIS 01.15S.100 AMIS LEG POSITIONER 2.0 FRAME

    MDR report key: 17697148 · Received September 7, 2023

    Report

    Report Number
    3005180920-2023-00678
    Event Type
    Injury
    Date Received
    September 7, 2023
    Date of Event
    August 8, 2023
    Report Date
    September 7, 2023
    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 (B)(6) 2023. LOT 2155343: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-FEB-2022. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICA AFFAIRS DEPARTMENT: DURING PRIMARY THA, THE GREATER TROCHANTER WAS FRACTURED DURING THE EXTERNAL ROTATION WITH THE LEG POSITIONER. ACCORDING TO REPORT, THE BONE QUALITY OF THE PATIENT WAS WEAK, AND ALSO FROM THE RADIOGRAPHIC IMAGE THIS CAN BE CONFIRMED. IN ORDER TO FIX THE FRACTURE, PLATE AND CABLES WERE PLACED. THERE IS NO REASON TO SUSPECT A FAULTY DEVICE. OTHER DEVICES INVOLVED: STEM: AMISTEM C 01.18.700 AMISTEM-C SHORT NECK STD STEM SIZE 0 LOT. 2240295 LOT 2240295: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-DEC-2022. EXPIRATION DATE: 2027-NOV-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. AMISTEM-C SN IS NOT REGISTERED IN USA.

    Description of Event or Problem · 0

    THE GREATER TROCHANTER WAS FRACTURED DURING THE EXTERNAL ROTATION WITH THE LEG POSITIONER. PLATE AND CABLES WERE PLACED TO FIX THE FRACTURE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE BONE QUALITY WAS WEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926315 AMIS 01.15S.100 AMIS LEG POSITIONER 2.0 FRAME HIP LEG POSITIONER FWX MEDACTA INTERNATIONAL SA 2155343

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other