BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H FEMORAL CEMENTLESS STEM SIZE 3 LAT

    MDR report key: 3465894 · Received October 31, 2013

    Report

    Report Number
    3005180920-2013-00132
    Event Type
    Injury
    Date Received
    October 31, 2013
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: QUADRA H CEMENTLESS FEMORAL STEM SIZE 3 LAT: REF. (B)(4) / LOT 091037 ((B)(4) STEM PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION PROCEDURES. ALL THE STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLID WITHOUT ANY OTHER SIMILAR INCIDENT. VERSAFITCUP CC HX PE LINER (K103352): REF. (B)(4) / LOT 113340 ((B)(4) LINERS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION PROCEDURES. THE (B)(4) ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. DOCUMENT REVIEW ON THE LOTS OF THE SHELL AND THE CERAMIC HEAD NOT MARKETED IN THE USA: ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION PROCEDURES. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCE THAT THE INFECTION IS DEVICE RELATED.

    Description of Event or Problem · 1

    PLEASE REFER IMPORTER REPORT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559072 QUADRA H FEMORAL CEMENTLESS STEM SIZE 3 LAT FEMORAL CEMENTLESS STEM JDI MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1