BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM

    MDR report key: 3162631 · Received June 5, 2013

    Report

    Report Number
    3006639916-2013-00061
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    December 24, 2010
    Report Date
    June 5, 2013
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE X-RAY TAKEN FIVE DAYS POST-OP ((B)(6) 2010), SHOWED A PERI-PROSTHETIC FRACTURE. CERCLAGE PERFORMED ON (B)(6) 2010. ON (B)(6) 2011, EVERYTHING WAS OK. SOME DAYS LATER, THE PT FELL WITH CRUTCHES AND FRACTURED THE SHAFT. IT WAS TREATED WITH OSTEOSYNTHESIS. REF 3005180920-213-00061.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249274 AMISTEM H FEMORAL STEM FEMORAL STEM SIZE 3 STD CEMENTLESS KWY MEDACTA INTERNATIONAL SA 102808

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention