BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMIS LEG POSITIONER

    MDR report key: 6180744 · Received December 16, 2016

    Report

    Report Number
    3005180920-2016-00669
    Event Type
    Injury
    Date Received
    December 16, 2016
    Date of Event
    November 18, 2016
    Report Date
    March 17, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    FWX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 13 MARCH 2017 THE R&D PROJECT MANAGER PERFORMED A VISUAL INSPECTION OF THE RETRIEVED ITEM AND COMMENTED AS FOLLOWS: FOLLOWING VISUAL AND FUNCTIONAL CHECKS OF THE ITEM, NO IMPROPRIERTIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON (B)(6) 2016 AND INCLUDES: THE NURSE WAS « EXPERT » AND USED TO MANIPULATE THE LEG POSITIONER BUT FIRST THE ROTATION WAS UNEASY AND THEN PROBABLY HAPPENED THE FRACTURE. HOWEVER THEY FINALLY NOTICED THE FRACTURE AT THE END OF THE INTERVENTION DURING THE REDUCTION. THE FRACTURE WAS FIXED DURING THE SAME INTERVENTION. ON (B)(6) 2016 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: THE SUCCESSION OF EVENTS IS NOT VERY CLEAR: APPARENTLY, A TIBIAL FRACTURE WAS GENERATED DURING THE THA OPERATION IN A VERY OSTEOPOROTIC PATIENT (ACCORDING TO REPORT), POSSIBLY DURING THE EXTERNAL ROTATION OF THE LIMB. THIS OPERATION IS DONE MANUALLY BY AN OR HELP, NORMALLY. IT IS NOT CLEAR HOW AND WHY MEDACTA DEVICES WOULD BE RESPONSIBLE FOR THIS EVENT. NO FINAL CONCLUSION CAN BE DRAWN WITH THE INFORMATION CURRENTLY AVAILABLE. BATCH REVIEWS PERFORMED ON (B)(6) 2016. AMIS MOBILE LEG POSITIONER 2.0, CODE 01.15.10.0190, LOT. 1411958 ONE ITEM MANUFACTURED AND RELEASED ON (B)(6) 2014. NO ANOMALIES FOUND RELATED TO THE PROBLEM. AMIS SHOE, CODE 01.15.10.0315 LOT 1551837: THE 30 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2015. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED ON ITEMS OF THE SAME LOT.

    Description of Event or Problem · 1

    AT THE END OF THE HIP SURGERY IT WAS NOTICED THAT THE TIBIA AROUND MALLEOLUS OF THE PATIENT WAS FRACTURED. THE NURSES IN THE OR FIRST HAD A HARD MANEUVER WITH EXTERNAL ROTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831175 AMIS LEG POSITIONER TABLE FOR SURGERY FWX MEDACTA INTERNATIONAL SA 1411958

    Patients

    Seq Age Sex Outcome Treatment
    1 Other