BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COR/TRI ANT STEM INSERT SHAFT

    MDR report key: 2901549 · Received January 8, 2013

    Report

    Report Number
    1818910-2013-10575
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 31, 2012
    Report Date
    December 31, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED INSTRUMENT 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. COMPLAINT SAMPLE WAS MANUFACTURED PRIOR TO THE DESIGN CHANGES. ADDITIONAL CORRECTIVE ACTION IS NOT INDICATED AT THIS TIME. CONTINUE TO MONITOR THROUGH TREND ANALYSIS. DEPUY CONSIDERS THE INVESTIGATION CLOSED. 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.

    Description of Event or Problem · 1

    THE TIP OF MODULAR STEM INSERTER BROKE OFF IN THE STEM AND WAS UNABLE TO BE REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9047 COR/TRI ANT STEM INSERT SHAFT HIP INSTRUMENT LXH DEPUY ORTHOPAEDICS, INC. PG1008

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention