BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COR/TRI ANT STEM INSERT SHAFT

    MDR report key: 3781216 · Received April 30, 2014

    Report

    Report Number
    1818910-2014-17806
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    April 22, 2014
    Manufacturer
    DEPUY-RAYNHAM, A DIV. OF DEPUY ¿ REG. # 1219655
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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

    ADDITIONAL NARRATIVE: 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. PROVIDED PATIENT X-RAYS WERE REVIEWED VIA COMACT-038348. 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    TIP OF THE INSERTER BROKE. THE TIP REMAINED IN THE SHOULDER OF THE IMPLANT AND WAS NOT NOTICED UNTIL POST-OP XRAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259858 COR/TRI ANT STEM INSERT SHAFT HIP INSTRUMENT/TRIAL LXH DEPUY-RAYNHAM, A DIV. OF DEPUY ¿ REG. # 1219655 PG1108

    Patients

    Seq Age Sex Outcome Treatment
    1 Other