BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLENOSPHERE ORIENTATION GUIDE

    MDR report key: 4534257 · Received February 23, 2015

    Report

    Report Number
    1818910-2015-14290
    Event Type
    Malfunction
    Date Received
    February 23, 2015
    Date of Event
    January 30, 2015
    Report Date
    June 17, 2015
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.1818910 DEPUY ORTH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. EXAMINATION OF THE RETURNED PRODUCT CONFIRMED THE PLASTIC PORTION OF THE TIP BROKE OFF. PREVIOUS INVESTIGATIONS FOUND THE METAL TIP BREAKAGE WAS DUE TO A TOO IMPORTANT STRESS DURING THE ASSEMBLY OF THE INSTRUMENT ONTO THE GLENOSPHERE. THE END TIP HAS BEEN CHANGED (ADDITION OF RADIUS AND BLEND) IN ORDER TO INCREASE THE STRENGTH OF THE COMPONENT, IMPLEMENTED ON MAY 19, 2008 VIA (B)(4). THE COMPLAINT SAMPLE IS THE NEW DESIGN MANUFACTURED AFTER THE CHANGE. THE DEPUY WARSAW MATERIAL RESEARCH DEPARTMENT EXAMINED THE RETURNED PRODUCT. THE ORIENTATION GUIDE FRACTURED DUE TO OVERLOAD. NO MATERIAL DEFECTS OR INCLUSIONS WERE NOTED THAT WOULD HAVE CONTRIBUTED TO THE CRACK INITIATION OR PROPAGATION. COMMERCIALIZED PRODUCT DEVELOPMENT IS AWARE OF THE FAILURE AND IS DETERMINING IF A DESIGN CHANGE IS INDICATED. CONTINUE TO MONITOR COMPLAINTS OF THE NEW DESIGN. 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.

    Description of Event or Problem · 1

    GLENOSPHERE PIN BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126147 GLENOSPHERE ORIENTATION GUIDE SHOULDER INSTRUMENT/TRIAL LXH 1818910 DEPUY ORTHOPAEDICS, INC.1818910 DEPUY ORTH 5037299

    Patients

    Seq Age Sex Outcome Treatment
    1