BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELITE PLUS SZ 1 ROUNDBACK

    MDR report key: 3110943 · Received May 14, 2013

    Report

    Report Number
    1818910-2013-17018
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    8010379 DEPUY INTL., LTD.
    Product Code
    KWY
    PMA / PMN Number
    PK871867
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    SUMMARY: 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 APPLIED RESEARCH REPORT IS COMPLETED.

    Description of Event or Problem · 1

    FEMORAL STEM HAS FRACTURED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212046 ELITE PLUS SZ 1 ROUNDBACK FEMORAL HIP STEM KWY 8010379 DEPUY INTL., LTD. 1106438

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention