BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H FEMORAL STEM

    MDR report key: 3162595 · Received June 5, 2013

    Report

    Report Number
    3006639916-2013-00057
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    March 25, 2009
    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

    PROXIMAL PERI-PROSTHETIC FEMORAL FRACTURE. POST-OP X-RAY WERE OK. THE PT HAD PAIN, CAME WITH X-RAY FROM ANOTHER HOSPITAL THAT SHOWED THE FRACTURE. REVISION WITH A CEMENTED STEM AND CERCLAGE OF THE FEMUR PERFORMED. REF MFR REPORT 3005180920-2013-00057.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249096 QUADRA H FEMORAL STEM FEMORAL STEM SIZE 7 STD CEMENTLESS LZO MEDACTA INTERNATIONAL SA 080990

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention