BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEM RASP TRIAL CO/FJD T11

    MDR report key: 7544193 · Received May 25, 2018

    Report

    Report Number
    1818910-2018-60501
    Event Type
    Malfunction
    Date Received
    May 25, 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 NOT RETURNED 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

    ESSENTIALLY, THE SURGEON 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
    389250 FEM RASP TRIAL CO/FJD T11 MISCELLANEOUS JOINT INSTRUMENTS : CUTTING INSTRUMENTS LXH DEPUY FRANCE SAS - 3003895575 1267417

    Patients

    Seq Age Sex Outcome Treatment
    1