BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELITE PLUS SZ 2 FLANGED

    MDR report key: 2990821 · Received March 6, 2013

    Report

    Report Number
    1818910-2013-13219
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REVIEW IDENTIFIED THAT INVESTIGATIONAL INPUT WOULD BE REQUIRED FROM BIOENGINEERING AND APPLIED RESEARCH. THE INVESTIGATION HAS BEEN IDENTIFIED FOR FURTHER IN-DEPTH ANALYSIS TO ASSIST IN THE DETERMINATION OF THE ROOT CAUSE AND HAS THEREFORE BEEN ASSIGNED TO BIOENGINEERING AND APPLIED RESEARCH. THE INVESTIGATION WILL BE CLOSED WITH AN INTERIM REPORT AND WILL BE REOPENED WHEN THE BIOENGINEERING AND OR APPLIED RESEARCH REPORT IS COMPLETED.

    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

    REVISION OF FRACTURED ELITE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95737 ELITE PLUS SZ 2 FLANGED HIP STEM KWY DEPUY ORTHOPAEDICS YGNXX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention