BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEM RASP TRIAL CO/FJD T12

    MDR report key: 7540899 · Received May 24, 2018

    Report

    Report Number
    1818910-2018-60425
    Event Type
    Malfunction
    Date Received
    May 24, 2018
    Report Date
    April 26, 2018
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    LXH
    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). INVESTIGATION SUMMARY: THE DEVICE WAS RETURNED 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 WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    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. DOE: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385857 FEM RASP TRIAL CO/FJD T12 MISCELLANEOUS JOINT INSTRUMENTS : CUTTING INSTRUMENTS LXH DEPUY FRANCE SAS - 3003895575 220074

    Patients

    Seq Age Sex Outcome Treatment
    1