BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H CEMENTLESS STEM SIZ 5 STD

    MDR report key: 3011081 · Received March 14, 2013

    Report

    Report Number
    3005180920-2013-00022
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    February 11, 2013
    Report Date
    March 14, 2013
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: QUADRA H CEMENTLESS FEMORAL STEM SIZE 5 STD - REF. 01.12.025 / LOT 103452 (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. THE 40 STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. FROM THE DATA COLLECTED THE EVENT IS HIGHLY LIKELY NOT DEVICE RELATED AND THE EXCESSIVE LOAD CARRIED OUT ONLY 3 MONTHS POST OP BY THE PT CAN BE A FACTOR IN THE EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO STEM QUADRA H SUBSIDENCE. IT WAS REPORTED THAT THE PT WAS OPERATED ON (B)(6) 2011 WITHOUT ANY ISSUES. ON (B)(6) 2011, 3 MONTHS POST OP, HE FELT WELL AND CARRIED VERY HEAVY OBJECTS. HE STATED COMPLAINING OF SEVERE PAIN THAT INCREASED OVER 3 MONTHS. ON OCTOBER X-RAY WAS TAKEN AND NO CHANGE IN STEM POSITION WAS NOTICED. A NEW X-RAY WAS TAKEN ON (B)(6) 2012 AND IT WAS NOTICED THAT THE FEMORAL STEM HAD SUBSIDED 1CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108277 QUADRA H CEMENTLESS STEM SIZ 5 STD CEMENTLESS FEMORAL STEM JDI MEDACTA INTERNATIONAL SA 103452

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other