BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ECC EPI TRIAL SZ2 LEFT

    MDR report key: 4944845 · Received July 28, 2015

    Report

    Report Number
    1818910-2015-26631
    Event Type
    Malfunction
    Date Received
    July 28, 2015
    Date of Event
    July 14, 2015
    Report Date
    July 14, 2015
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED TO THE COMPLAINT WERE RETURNED FOR ANALYSIS. THE DHR ANALYSIS OF THE CONCERNED BATCHES SHOWS THAT THE LABELS WERE PRINTED ON THE SAME DAY, DECEMBER 8TH, 2011 FOR BOTH BATCHES. 2 SUPPLEMENTARY LABELS WERE REPRINTED FOR BATCH 5111794 DUE TO A PRINTING ISSUE. BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATIONS PERFORMED, THE ROOT CAUSE OF THE INCIDENT IS RELATED TO A SUPPLIER LABELING ERROR. A PREVIOUS COMPLAINT WAS REPORTED FOR THIS ISSUE (B)(4). SUPPLIER CORRECTIVE ACTIONS WERE IMPLEMENTED IN 2012 THROUGH THE CAPA (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. (B)(4).

    Description of Event or Problem · 1

    I HAVE JUST BEEN PASSED THIS PRODUCTS FROM KIT BUILD AS IT LOOKS TO BE THE WRONG ITEM IN THE PACKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490998 MODULAR ECC EPI TRIAL SZ2 LEFT SHOULDER INSTRUMENT/TRIAL LXH DEPUY FRANCE SAS 3003895575 5111794

    Patients

    Seq Age Sex Outcome Treatment
    1