BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H FEMORAL STEM

    MDR report key: 3162714 · Received June 5, 2013

    Report

    Report Number
    3005180920-2013-00055
    Event Type
    Injury
    Date Received
    June 5, 2013
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K082792
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: QUADRA H FEMORAL STEM SIZE 5 LAT - (B)(4)/LOT 061382 (25 STEMS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDED WASHING AND STERILIZATION CYCLES. TWENTY-TWO STEMS BELONGING TO THIS LOT HAVE ALREADY BEEN IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED UP TO NOW. ALSO THE DOCUMENT REVIEWS OF THE OTHER THREE COMPONENTS IMPLANTED (SHELL-LINER-HEAD) HAVE THE SAME CONCLUSIONS AND ALMOST ALL THE ITEMS OF THE LOTS INVOLVED (PRODUCED IN 2005) HAVE BEEN ALREADY IMPLANTED WITHOUT ANY OTHER SIMILAR ISSUES. FROM THE DATA COLLECTED, THE INFECTION IS HIGHLY LIKELY NOT DEVICE RELATED.

    Description of Event or Problem · 1

    REF IMP REPORT: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248800 QUADRA H FEMORAL STEM FEMORAL STEM SIZE 5 LAT CEMENTLESS LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1