BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H CEMENTLESS FEMORAL STEM

    MDR report key: 3192519 · Received June 21, 2013

    Report

    Report Number
    3005180920-2013-00072
    Event Type
    Injury
    Date Received
    June 21, 2013
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: AMISTEM H CEMENTLESS FEMORAL STEM SIZE 3 STD: REF (B)(4)/LOT 110841 (60 STEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THE WASHING CYCLE FOR METAL COMPONENTS WAS RUN ACCORDING TO SPECIFICATIONS AND NO ALARM OR DEVIATION OCCURRED DURING OPERATION. THE STERILIZATION CYCLE WAS PERFORMED ACCORDING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. FIFTY-FOUR STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED WITHOUT ANY OTHER SIMILAR INCIDENT. COCR BALL HEAD REF (B)(4)/LOT 111578 (40 HEADS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THE WASHING CYCLE FOR METAL COMPONENTS WAS RUN ACCORDING TO SPECIFICATIONS AND NO ALARM OR DEVIATION OCCURRED DURING OPERATION. THE STERILIZATION CYCLE WAS PERFORMED ACCORDING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. TWENTY-EIGHT HEADS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED WITHOUT ANY OTHER SIMILAR INCIDENT. VERSAFITCUP CC LINER REF (B)(4)/LOT111954 (59 LINERS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THE WASHING CYCLE FOR METAL COMPONENTS WAS RUN ACCORDING TO SPECIFICATIONS AND NO ALARM OR DEVIATION OCCURRED DURING OPERATION. THE STERILIZATION CYCLE WAS PERFORMED ACCORDING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. FORTY-TWO LINERS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED WITHOUT ANY OTHER SIMILAR INCIDENT. FROM THE DATA COLLECTED, THERE IS NO EVIDENCE THAT THE INFECTION IS DEVICE RELATED.

    Description of Event or Problem · 1

    REF IMP REPORT: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283125 AMISTEM H CEMENTLESS FEMORAL STEM FEMORAL STEM SIZE 3 STANDARD LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1