BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COR/TRI ANT STEM INSERT SHAFT

    MDR report key: 3950099 · Received July 22, 2014

    Report

    Report Number
    1818910-2014-23982
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 18, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED INSTRUMENTS CONFIRMS THE OBSERVATION. 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. 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. THE PRODUCT ASSOCIATED WITH THIS COMPLAINT WAS MANUFACTURED IN MARCH OF 2010; AFTER THE DESIGN IMPROVEMENT. 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 SEP 419 POST MARKET ANALYSIS. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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

    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

    INSERTER TIP BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428885 COR/TRI ANT STEM INSERT SHAFT HIP INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. 1818910 PG0310

    Patients

    Seq Age Sex Outcome Treatment
    1