BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA C CEMENTED STEM SIZE 1

    MDR report key: 2956750 · Received January 14, 2013

    Report

    Report Number
    3005180920-2012-00100
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 6, 2012
    Report Date
    January 14, 2013
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K083558
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: QUADRA C CEMENTED FEMORAL STEM SIZE 1- REF. 01.12.041 / LOT 111634 (50 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 32 STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. THE REASON OF THE FRACTURE IS UNKNOWN; FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED.

    Description of Event or Problem · 1

    PATIENT HAD A FRACTURE OF THE FEMORAL SHAFT. THE STEM QUADRA C WAS REMOVED AND REPLACED BY ANOTHER QUADRA C. A CABLE WAS USED TO FIX THE FRACTURE. WE WERE INFORMED ON (B)(6) 2012 ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20522 QUADRA C CEMENTED STEM SIZE 1 CEMENTED FEMORAL STEM LZO MEDACTA INTERNATIONAL, SA 111634

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other