BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COR/TRI ANT STEM INSERT SHAFT

    MDR report key: 2061804 · Received April 1, 2011

    Report

    Report Number
    1818910-2011-05498
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    THE TIP OF THE INSERTER SHAFT BROKE DURING STEM INSERTION. THE TIP REMAINED IN THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COR/TRI ANT STEM INSERT SHAFT 87 LXH LXH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR