BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEM RASP TRIAL CO/FJD T11

    MDR report key: 7544161 · Received May 25, 2018

    Report

    Report Number
    1818910-2018-60493
    Event Type
    Malfunction
    Date Received
    May 25, 2018
    Report Date
    April 26, 2018
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    MDM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # : (B)(4). THE RETURNED DEVICE WAS EXAMINED, AND FAILURE MODE CONFIRMED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH , A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    PLEASE SEE EMAIL BELOW FROM (B)(6) AT (B)(6) HOSPITAL. I¿M RAISING THIS AS AN OFFICIAL COMPLAINT AS IT APPEARS THIS IS A RECURRING PROBLEM THAT THE SURGEON HAS RAISED PREVIOUSLY WITH MY PREDECESSOR, (B)(6). ESSENTIALLY, (B)(6) USES THE FIRST GENERATION OF CORAIL INSTRUMENTS AND IS FINDING THAT THERE IS A MISMATCH BETWEEN WHERE THE BROACH SITS AND THE DEFINITIVE STEM. UPON INTRODUCING THE DEFINITIVE HE IS FINDING THAT THE CORAIL STEM SITS A FEW MM PROUDER COMPARED TO THE BROACH AND AS A RESULT (B)(6) HAS RECENTLY HAD TO REVISE PATIENTS FOR PERIPROSTHETIC FRACTURES. I DON¿T YET HAVE ANY FURTHER DETAILS, PLEASE ADVISE WHAT SPECIFICS YOU REQUIRE. (B)(6)AND I ARE GOING TO FOLLOW UP WITH HIM ABOUT THIS, I FEEL IT MAY ALSO PROVE WORTHWHILE FOR THE ENGINEERING TEAM TO PLEASE ARRANGE A VISIT TO SUPPORT WITH THIS ISSUE AS WELL. HELLO, WE HAD 2 PROUD CORAIL IMPLANTS YESTERDAY DUE TO RASP IMPLANT MISMATCH. WE HAVE ONE PATIENT COMING BACK TO THEATRE FOR REVISION FOR FRACTURE DUE TO THE SAME ISSUE. I HOPE YOU CAN UNDERSTAND THERE IS SOME DISPLEASURE. THE HOSPITAL WILL RAISE THESE 3 WITH THE MRHA TO DO THEIR THING. MY VIEW REMAINS THAT THE TRIAL SHOULD BE THE SAME SIZE AS THE IMPLANT, OTHERWISE IT IS NOT POSSIBLE TO DO A TRIAL REDUCTION RE LENGTH AND STABILITY. THE GOOD NEWS IS THE THIRD HIP REPLACEMENT THE IMPLANT SEATED TO THE LEVEL OF THE PRE RASPED FEMUR. THIS COMPLAINT CAPTURES THE ONE PATIENT WHO IS RETURNING BACK TO THEATRE FOR REVISION FOR FRACTURE DUE TO THE SAME ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389248 FEM RASP TRIAL CO/FJD T11 MISCELLANEOUS JOINT INSTRUMENTS : CUTTING INSTRUMENTS MDM DEPUY FRANCE SAS 3003895575 5220073

    Patients

    Seq Age Sex Outcome Treatment
    1