BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM BROACH SIZE 2

    MDR report key: 6063508 · Received October 28, 2016

    Report

    Report Number
    3005180920-2016-00553
    Event Type
    Injury
    Date Received
    October 28, 2016
    Date of Event
    September 29, 2016
    Report Date
    October 28, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: INTRAOPERATIVE FEMORAL FRACTURES ARE KNOWN POSSIBLE ADVERSE EVENTS OF TOTAL HIP REPLACEMENTS, DESCRIBED AND QUANTIFIED IN LITERATURE. THEY MAINLY DEPEND ON BONE MORPHOLOGY AND MECHANICAL PROPERTIES. IN THIS CASE, THERE IS NO REASON TO SUSPECT A MALFUNCTIONING DEVICE. BATCH REVIEW PERFORMED ON (B)(4) 2016. LOT 1213490: 20 ITEMS MANUFACTURED AND RELEASED ON 11 SEPTEMBER 2013. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENTS HAVE BEEN ON ITEMS OF THE SAME LOT.

    Description of Event or Problem · 1

    DURING A PRIMARY HIP CASE WHEN THE SURGEON WAS BROACHING, A FRACTURE OCCURRED IN THE MEDICAL CALCAR. THE SURGEON USED CABLES TO STABILIZE THE FRACTURE. THE SURGERY WAS DELAYED APPROXIMATELY 30 MINUTES. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716467 AMISTEM BROACH SIZE 2 SURGICAL INSTRUMENTS FOR HIP LXH MEDACTA INTERNATIONAL SA 1213490

    Patients

    Seq Age Sex Outcome Treatment
    1 Other