BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM

    MDR report key: 3080791 · Received April 15, 2013

    Report

    Report Number
    3006639916-2013-00039
    Event Type
    Injury
    Date Received
    April 15, 2013
    Date of Event
    March 14, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MEDACTA INTL SA
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY OF THE STEM AMISTEM H 1 WEEK POST OP. THE PT IS (B)(6), HE IS A VERY ACTIVE PERSON. AFTER THE SURGERY, HE WAS ABLE TO WALK WITH THE HELP OF A WALKER. HE WAS FOUND ON HIS BED WITH THE OPERATED LEG EXTERNAL ROTATED AS IF IT WERE DISLOCATED. NO EXPLICATION WAS GIVEN BY THE SURGEON ABOUT THE DATE OF THE OCCURRENCE AND WHO FOUND THE PT. IT WAS REPORTED THAT THE PT DID NOT COMPLAIN SINCE HE WAS IN ANY CASE ACTIVE DESPITE THE EVENT. PLEASE REF MFR REPORT # 3005180920-2013-00039.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161205 AMISTEM H FEMORAL STEM FEMORAL STEM SIZE 2 LAT CEMENTLESS LZO MEDACTA INTL SA 123318

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention