BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY ACETABULAR SHELL WITH CLUSTER HOLES

    MDR report key: 1950103 · Received December 7, 2010

    Report

    Report Number
    1822565-2010-01274
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    October 27, 2010
    Report Date
    November 8, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE TRILOGY CUP HAD WIRE FROM FIBER MESH STICKING OUT, WHICH CAUGHT AND RIPPED THE GLOVE OF THE SCRUB NURSE. SURGERY WAS COMPLETED WITH A DIFFERENT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY ACETABULAR SHELL WITH CLUSTER HOLES HIP PROSTHESIS JDI ZIMMER, INC. 61439045

    Patients

    Seq Age Sex Outcome Treatment
    1