BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COR/TRI ANT STEM INSERT SHAFT

    MDR report key: 3516701 · Received December 12, 2013

    Report

    Report Number
    1818910-2013-35841
    Event Type
    Malfunction
    Date Received
    December 12, 2013
    Date of Event
    November 15, 2013
    Report Date
    November 15, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 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. 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 RETURNED INSTRUMENT WAS MANUFACTURED IN 2008; PRIOR THE DESIGN IMPROVEMENT. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    INSTRUMENT IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650686 COR/TRI ANT STEM INSERT SHAFT HIP INSTRUMENT LXH 1818910 DEPUY ORTHOPAEDICS, INC. PG1008

    Patients

    Seq Age Sex Outcome Treatment
    1