BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR FEMORAL HEAD 32 SIZE M

    MDR report key: 3226015 · Received July 3, 2013

    Report

    Report Number
    3005180920-2013-00074
    Event Type
    Injury
    Date Received
    July 3, 2013
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K072857
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: COCR BALL HEAD REF. (B)(4) / LOT 070395 ((B)(4) 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. THE (B)(4) HEADS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED WITHOUT ANY OTHER SIMILAR INCIDENT. QUADRA H CEMENTLESS FEMORAL STEM SIZE 7 LAT (K082792): REF. (B)(4) / LOT 061361 ((B)(4) 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. THE (B)(4) STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED WITHOUT ANY OTHER SIMILAR INCIDENT. VERSAFITCUP CC LINER REF. (B)(4) / LOT 062082 (14 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. THE 11 LINERS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED WITHOUT ANY OTHER SIMILAR INCIDENT. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES 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
    303691 COCR FEMORAL HEAD 32 SIZE M FEMORAL BALL HEAD LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1