BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COR/TRI ANT STEM INSERT SHAFT

    MDR report key: 3946321 · Received July 21, 2014

    Report

    Report Number
    1818910-2014-23831
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED PRODUCT SAMPLE CONFIRMS THE COMPLAINT. PREVIOUS INVESTIGATIONS, INCLUDING EVALUATIONS BY A DEPUY MATERIAL SCIENTIST HAS DETERMINED THAT USE ERROR IS THE MOST LIKELY ROOT CAUSE. MANUFACTURING OR MATERIAL ERROR WAS NOT IDENTIFIED. IT IS HOWEVER RECOGNIZED THAT IMPROVEMENTS ARE POSSIBLE TO ALLEVIATE THIS ISSUE EVEN IF NOT USED PROPERLY. ECO 292374 WAS APPROVED AND COMPLETED ON JANUARY 15, 2010, WHICH INCLUDES IMPROVEMENTS TO BOLSTER THE DURABILITY OF THIS INSTRUMENT. THE RETURNED PRODUCT SAMPLE WAS MANUFACTURED IN JULY OF 2013; AFTER THE DESIGN IMPROVEMENT. HEALTH HAZARD EVALUATIONS PRA-860-2009-HHE IN MARCH 2009 AND DVA-105642-HHE IN JANUARY 2011 WERE HELD TO DETERMINE THE RISK INVOLVED WITH THE TIP OF A MODULAR STEM INSERTER BREAKING OFF DURING SURGERY. THE HHE FROM 2009 AND AGAIN IN 2011 CONCLUDED THAT NO FIELD ACTION WAS REQUIRED. BECAUSE THERE HAVE NOW BEEN FAILURES REPORTED INVOLVING THE IMPROVED DESIGN, AN ADDITIONAL PRELIMINARY RISK ASSESSMENT, DVA-107766-PRA WAS INITIATED IN JANUARY 2013. THE PRELIMINARY RISK ASSESSMENT CONCLUDED THERE WAS NO ADDITIONAL OR NEW PATIENT HARM ASSOCIATED WITH THE DEVICES. ADDITIONAL CORRECTIVE ACTION IS NOT INDICATED AT THIS TIME. CONTINUE TO MONITOR THROUGH TREND ANALYSIS. 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

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

    Description of Event or Problem · 1

    TIP BROKE OFF THE FEMORAL IMPACTOR DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424319 COR/TRI ANT STEM INSERT SHAFT HIP INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. PG232121

    Patients

    Seq Age Sex Outcome Treatment
    1