BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY SHELL WITH CLUSTER HOLES

    MDR report key: 2860622 · Received December 5, 2012

    Report

    Report Number
    2648920-2012-00257
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    September 20, 2012
    Report Date
    November 9, 2012
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE LINER WOULD NOT FIT IN THE SHELL. A DIFFERENT ONE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY SHELL WITH CLUSTER HOLES LPH ZIMMER MANUFACTURING B.V. 61943341

    Patients

    Seq Age Sex Outcome Treatment
    1 TRILOGY LONGEVITY LINER: CATALOG #00631005032| LOT #61933031