BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY ACETABULAR SHELL WITH CLUSTER HOLES

    MDR report key: 1932186 · Received December 14, 2010

    Report

    Report Number
    1822565-2010-01333
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    ZIMMER
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    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 AS THE HOSPITAL SCRUB TECH OPENED FINAL STERILE PACKAGE AND REMOVED THE CUP, A STRAND OF THE FIBER METAL MESH WAS PROTRUDING FROM THE CUP PENETRATED THE SCRUB TECH'S GLOVE AND CONTAMINATED THE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY ACETABULAR SHELL WITH CLUSTER HOLES HIP PROSTHESIS JDI ZIMMER 61471002

    Patients

    Seq Age Sex Outcome Treatment
    1