BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEM RASP TRIAL CO/FJD T16

    MDR report key: 7544517 · Received May 25, 2018

    Report

    Report Number
    1818910-2018-60562
    Event Type
    Malfunction
    Date Received
    May 25, 2018
    Date of Event
    April 25, 2018
    Report Date
    April 26, 2018
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    MDM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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). NO DEVICE WAS RECEIVED. 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.

    Description of Event or Problem · 1

    TWO PROUD CORAIL IMPLANTS YESTERDAY DUE TO RASP IMPLANT MISMATCH. AT THIS TIME IT'S UNKNOWN WHAT SIZE OF BROACH/RASP WERE USED DURING THESE CASES. ALL ARE BEING REPORTED AT THIS TIME ON LINKED PCS. THE TWO STEMS ARE REPORTED IN TWO SEPARATE LINKED PCS.  DOE: (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389061 FEM RASP TRIAL CO/FJD T16 CORAIL KAR INSTRUMENTS : FEMORAL TRIALS MDM DEPUY FRANCE SAS - 3003895575 5220077

    Patients

    Seq Age Sex Outcome Treatment
    1