BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY SHELL WITH CLUSTER HOLES POROUS

    MDR report key: 1932003 · Received November 30, 2010

    Report

    Report Number
    1822565-2010-01232
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 2, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 AS THE SURGEON WAS RECEIVING THE IMPLANT FROM THE SCRUB NURSE, A PIECE OF THE FIBER METAL MESH AT THE EQUATOR OF THE CUP PIERCED THE SURGEON'S DOUBLE GLOVES AND PRICKED HIS FINGER, DRAWING BLOOD. THE SURGEON WAS NOT INJURED, BUT HAD TO RE-GLOVE, SCRUB HIS HANDS AGAIN, RE-GLOVE AND IMPLANT ANOTHER CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY SHELL WITH CLUSTER HOLES POROUS HIP PROSTHESIS KWB ZIMMER, INC. 61417327

    Patients

    Seq Age Sex Outcome Treatment
    1