BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPT FEMORAL STEM

    MDR report key: 2973999 · Received February 19, 2013

    Report

    Report Number
    2648920-2013-00047
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 21, 2013
    Manufacturer
    ZIMMER
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FORM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON DECIDED TO USE A SIZE 4 CPT STEM, WHEN HE OPENED THE PACKAGE HE FOUND A SIZE 2 CPT STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72643 CPT FEMORAL STEM JDI ZIMMER 62056004

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR LOT# 62076921| CPT FEMORAL STEM: CATALOG #00801100200