BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEM RASP TRIAL CO/FJD T8

    MDR report key: 7544094 · Received May 25, 2018

    Report

    Report Number
    1818910-2018-60477
    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
    HTR
    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). THE DEVICE WAS RETURNED, AND THE FAILURE MODE WAS 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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # : (B)(4). THE DEVICE WAS RETURNED, AND THE FAILURE MODE WAS 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

    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 STEM ARE REPORTED TWO STEMS ARE REPORTED IN TWO SEPARATE LINKED PCS. DOE: (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389242 FEM RASP TRIAL CO/FJD T8 OTHER PRODUCTS HTR DEPUY FRANCE SAS - 3003895575 5220070

    Patients

    Seq Age Sex Outcome Treatment
    1