BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLENOSPHERE ORIENTATION GUIDE

    MDR report key: 5433322 · Received February 12, 2016

    Report

    Report Number
    1818910-2016-13177
    Event Type
    Malfunction
    Date Received
    February 12, 2016
    Date of Event
    February 5, 2016
    Report Date
    February 5, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. PREVIOUS INVESTIGATIONS FOUND THE DEPUY WARSAW MATERIAL RESEARCH DEPARTMENT EXAMINED THE NEWER DESIGN FAILURES AND FOUND THE ORIENTATION GUIDES 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 THROUGH POST MARKET SURVEILLANCE (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

    LOT CODE ADDED 5221275.MANUFACTURE DATE ADDED FEB 3, 2014.(B)(4). 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

    (B)(4). 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

    EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE REPORTED EVENT OF TIP BREAKAGE. PREVIOUS SIMILAR INVESTIGATION EVALUATED BY DEPUY MATERIAL SCIENCE FOUND THE FAILURE IS CONSISTENT WITH AN OVERLOAD FRACTURE. NO MATERIAL DEFECTS OR INCLUSIONS WERE NOTED THAT WOULD HAVE CONTRIBUTED TO THE CRACK INITIATION OR PROPAGATION. BASED ON PREVIOUS EVALUATIONS, THE ROOT CAUSE IS ATTRIBUTED TO MISUSE/MISAPPLICATION OF THE DEVICE. DUE TO THE ROOT CAUSE OF MISUSE/MISAPPLICATION, ADDITIONAL CORRECTIVE ACTION IS NOT INDICATED AT THIS TIME. CONTINUE TO MONITOR VIA SEP-419. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    THE GLENOSPHERE ORIENTATION GUIDE BROKE AT THE TIP.

    Description of Event or Problem · 1

    UPDATE 11/7/2016- THE COMPLAINT HAS BEEN REOPENED TO UPDATE THE ROOT CAUSE WITHIN THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91253 GLENOSPHERE ORIENTATION GUIDE SHOULDER INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. 5221275

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR