BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL CEMENTLESS STEM SIZE 4 LAT

    MDR report key: 3261053 · Received July 18, 2013

    Report

    Report Number
    3005180920-2013-00085
    Event Type
    Injury
    Date Received
    July 18, 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 4 LAT: REF (B)(4)/LOT 104019 (50 STEM PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG. THE WASHING CYCLE FOR METAL COMPONENTS WAS RUN ACCORDING TO SPECS AND NO ALARM OR DEVIATION OCCURRED DURING OPERATION. THE STERILIZATION CYCLE WAS PERFORMED ACCORDING TO SPECS VALID AT THE TIME OF PRODUCTION. FORTY STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED WITHOUT ANY OTHER SIMILAR INCIDENT. VERSAFITCUP CC TRIO CUP (B)(4), /LOT 121427 (66 CUPS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG. THE WASHING CYCLE FOR METAL COMPONENTS WAS RUN ACCORDING TO SPECS AND NO ALARM OR DEVIATION OCCURRED DURING OPERATION. THE STERILIZATION CYCLE WAS PERFORMED ACCORDING TO SPECS VALID AT THE TIME OF PRODUCTION. FIFTY-EIGHT SHELLS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED WITHOUT ANY OTHER SIMILAR INCIDENT. VERSAFITCUP CC LINER, REF (B)(4)/LOT 122080 (39 LINERS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG. THE WASHING CYCLE FOR PLASTIC COMPONENTS WAS RUN ACCORDING TO SPECS AND NO ALARM OR DEVIATION OCCURRED DURING OPERATION. THE STERILIZATION CYCLE WAS PERFORMED ACCORDING TO SPECS VALID AT THE TIME OF PRODUCTION. TWENTY-FOUR LINERS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED WITHOUT ANY OTHER SIMILAR INCIDENT. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCE THAT THE INFECTION IS DEVICE RELATED.

    Description of Event or Problem · 1

    PLEASE SEE REFERENCE IMPORTER NUMBER: 3006639916-2013-00085.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335455 AMISTEM H FEMORAL CEMENTLESS STEM SIZE 4 LAT FEMORAL CEMENTLESS STEM LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1