BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA HP FEM NOTCH IMPACTOR

    MDR report key: 3599555 · Received January 30, 2014

    Report

    Report Number
    1818910-2014-11843
    Event Type
    Malfunction
    Date Received
    January 30, 2014
    Date of Event
    January 20, 2014
    Report Date
    January 20, 2014
    Manufacturer
    1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE REPORT STATES: THE COMPLAINT WAS RECEIVED INTO THE LEEDS QUALITY DEPARTMENT 06-FEB-2014 FOLLOWING RECEIPT OF PRODUCT IT WAS TRANSFERRED TO INVESTIGATION ON 14-MARCH-2014. VISUAL EXAMINATION OF THE RETURNED FEMORAL NOTCH IMPACTOR; PRODUCT CODE: 950501218, LOT NUMBER: J0510 CONFIRMED THAT THE BLACK PLASTIC PART OF THE IMPACTOR HAD BROKEN AWAY FROM THE METAL BODY. A COMPLAINTS DATABASE SEARCH MADE ON PRODUCT CODE 950501218 IDENTIFIED SIMILAR COMPLAINTS RECEIVED PREVIOUSLY. FOLLOWING RECEIPT OF PREVIOUS COMPLAINTS NOTIFICATION WAS RECEIVED FROM DESIGN ENGINEERING ON 25-APRIL-13 ADVISING THAT THE ISSUE OF BREAKAGE OF RADEL HANDLES THAT ARE IMPACTED HAD NOW BEEN REVIEWED BY THE CAPA REVIEW BOARD AND IDENTIFIED FOR FURTHER ACTION. DATA REVIEW NO. DR-000714 WAS RAISED FOR FURTHER INVESTIGATION, TO INCLUDE REFERENCE TO DATA REVIEW ACTIVITY NO. DRA-001725. THE OUTCOME OF DRA-001725 STATED THAT THERE IS NO SYSTEMATIC FAILURE OF EXTRUDED RADEL AS A MATERIAL FOR USE IN THESE INSTRUMENTS. SINCE THIS PRODUCT FALLS UNDER THE 2% THRESHOLD AS AGREED AT THE CAPA REVIEW BOARD NO FURTHER ACTION WILL BE UNDERTAKEN. CONCLUSION AND JUSTIFICATION STATUS: INSPECTION OF THE RETURNED PRODUCT CONFIRMED THE PRODUCT BREAKAGE AS REPORTED. THE ISSUE WAS RAISED UNDER REFERENCE DRA-001725 AND CONCLUDED THAT NO ACTION WILL BE TAKEN AT THIS TIME. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION AND WILL BE ENTERED INTO THE COMPLAINT DATABASE AND MONITORED THROUGH TREND ANALYSIS.

    Description of Event or Problem · 1

    FEMORAL IMPACTOR IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66367 SIGMA HP FEM NOTCH IMPACTOR KNEE INSTRUMENT/TRIAL LXH 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC J0510

    Patients

    Seq Age Sex Outcome Treatment
    1