BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC* FLUT TIB ROD TRL 75 X 14

    MDR report key: 3040211 · Received April 8, 2013

    Report

    Report Number
    1818910-2013-15025
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND ADDITIONAL REPORTS OF BREAKAGE. PRODUCT DEVELOPMENT ENGINEERING STATED THE CONCERN OF STEM ROD TRIAL TIP DISASSOCIATION IS CURRENTLY BEING INVESTIGATED AND REQUIRES FURTHER INVESTIGATION TO IDENTIFY ROOT CAUSE AND CORRECTIVE ACTIONS. (B)(4) WAS INITIATED TO IDENTIFY ROOT CAUSE AND CORRECTIVE ACTIONS. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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 A UNIVERSAL STEM TRIAL BROKE OFF IN THE PATIENT'S FEMUR, AND THE SURGEON WAS UNABLE TO RETRIEVE IT. THIS ALSO CAUSED A SURGICAL DELAY OF 45-60 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144189 PFC* FLUT TIB ROD TRL 75 X 14 KNEE INSTRUMENT LXH DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS KA0707

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention