BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COR/TRI ANT STEM INSERT SHAFT

    MDR report key: 2853233 · Received November 30, 2012

    Report

    Report Number
    1818910-2012-26934
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    DEPUY WARSAW
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 WAS HOWEVER RECOGNIZED THAT IMPROVEMENTS WERE POSSIBLE TO ALLEVIATE THIS ISSUE EVEN IF NOT USED PROPERLY. (B)(4) WAS APPROVED AND COMPLETED ON (B)(6) 2010, WHICH INCLUDES IMPROVEMENTS TO BOLSTER THE DURABILITY OF THIS INSTRUMENT. 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 TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    MODULAR TRILOCK ANTERIOR STEM INSERTER TIP BROKE OFF IN STEM. THE TIP COULD NOT BE REMOVED FROM THE STEM AND WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COR/TRI ANT STEM INSERT SHAFT HIP INSTRUMENT LXH DEPUY WARSAW PG0811

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention