BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H FEMORAL CEMENTLESS STEM SIZE 3 STD

    MDR report key: 3290224 · Received August 5, 2013

    Report

    Report Number
    3005180920-2013-00095
    Event Type
    Injury
    Date Received
    August 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 CEMENTLESS STEM SIZE 3 STD: REF. 01.12.023 / LOT 101888 (B)(4): VERSAFITCUP CC LIGHT CUP (NOT MARKETED IN THE USA) REF 01.26.54MBTL / LOT 101388 (B)(4). VERSAFITCUP CC LINER (K103352) REF. 01.26.3244HCT / LOT 101866 (B)(4). ALL PARAMETERS HAVE BEEN FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MFG. THE WASHING CYCLES WERE RUN ACCORDING TO SPECIFICATIONS AND NO ALARM OR DEVIATION OCCURRED DURING OPERATION. THE STERILIZATION CYCLES WERE PERFORMED ACCORDING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION FOR THE THREE LOTS. CERAMIC BALL HEAD MFG BY CERAMTEC AND NOT MARKETED IN THE USA: STERILIZATION CORRECTLY PERFORMED. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366690 QUADRA H FEMORAL CEMENTLESS STEM SIZE 3 STD FEMORAL CEMENTLESS STEM LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1