BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY SHELL WITH CLUSTER HOLES

    MDR report key: 3023220 · Received February 27, 2013

    Report

    Report Number
    2648920-2013-00056
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    Manufacturer
    ZIMMER
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM 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 LINER WAS DIFFICULT TO INSERT INTO THE SHELL. NEW COMPONENTS WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85207 TRILOGY SHELL WITH CLUSTER HOLES LPH ZIMMER 62140525

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR TRILOGY LONGEVITY POLY LINER: CATALOG #00630505032| LOT #62224379