BEUDAMED
    FDA Adverse Event Summary report: N

    AMISTEM H FEMORAL STEM

    MDR report key: 3162655 · Received June 5, 2013

    Report

    Report Number
    3006639916-2013-00062
    Date Received
    June 5, 2013
    Date of Event
    June 17, 2010
    Report Date
    June 5, 2013
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    POST-OPERATIVELY THE PT HAD PAIN AND THERE WAS SINKING OF THE STEM. THE PT REFUSED TO BE RE-OPERATED. ONE MONTH POST-OP, THE X-RAY SHOWED A PERI-PROSTHETIC FRACTURE. NO RE-OPERATION, AUTOHEALING. REF MFR REPORT 3005180920-2013-00062.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249072 AMISTEM H FEMORAL STEM FEMORAL STEM SIZE 3 STD CEMENTLESS LZO MEDACTA INTERNATIONAL SA 093011

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other