BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA S FEMORAL CEMENTLESS STEM

    MDR report key: 3080752 · Received April 8, 2013

    Report

    Report Number
    3006639916-2013-00032
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 9, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MEDACTA USA INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD A VERY SOFT BONE. THE SURGEON¿S PLAN WAS TO BROACH AND TRY FOR A PRESS-FIT STEM AND IF HE FELT LIKE HE NEED TO GO CEMENTED. HE BROACHED TO A SIZE 3 AND WHILE IMPLANTING THE ACTUAL STEM, IT ADVANCED INTO THE CANAL PAST THE POINT OF BROACHING. AT THIS POINT, HE WAS AFRAID THAT HE EITHER HAD A SMALL FRACTURE OR THAT THE STEM WOULD SUBSIDE DUE TO WEAK OSTEOPOROTIC BONE. HE DECIDED TO PULL THE PRESS-FIT STEM OUT AND CEMENT A QUADRA C IN. AFTER THE QUADRA C WAS IN AND THE CEMENT CURED, HE TRIALED THE CONSTRUCT AND UPON X-RAY WE COULD NOT SEE A FRACTURE HOWEVER, THERE WAS A MASS OF CEMENT ON THE OUTSIDE OF THE FEMUR IN LINE WITH THE STEM IN BETWEEN THE OUTSIDE OF THE FEMUR AND THE SOFT TISSUE. HE ASSUMED THAT THERE MUST HAVE BEEN A FRACTURE FOR THAT MUCH CEMENT TO GET OUT. POST OP CT SCAN REPORT SAID NO FRACTURE BUT ON CLOSER LOOK HE THINKS THAT THERE IS A FRACTURE IN LINE WITH THE STEM ADJACENT TO THE CEMENT ABOUT 10CM IN LENGTH. DECIDED NOT TO REVISE. PLEASE REFERENCE MFR REPORT NUMBER: 3005180920-2013-00032.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144554 QUADRA S FEMORAL CEMENTLESS STEM FEMORAL STEM SIZE 3 SHORT NECK STD JDI MEDACTA USA INC. 103965

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other