BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY SHELL WITH CLUSTER HOLES

    MDR report key: 2843470 · Received November 15, 2012

    Report

    Report Number
    1822565-2012-02341
    Event Type
    Injury
    Date Received
    November 15, 2012
    Report Date
    October 16, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A FOREIGN CONSUMER 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 PT IS EXPERIENCING PAIN. THE PT HAS REPORTEDLY EXPERIENCED INCONTINENCE PROBLEMS AS WELL AS A LIGAMENT TEAR POST SURGERY. TREATMENT HAS INCLUDED AN INJECTION AND PAIN RELIEF MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY SHELL WITH CLUSTER HOLES MEH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other LOT #UNK| TRILOGY LONGEVITY POLY LINER: CATALOG #00631005032