BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY SHELL WITH CLUSTER HOLES

    MDR report key: 2861557 · Received November 28, 2012

    Report

    Report Number
    2648920-2012-00249
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 29, 2012
    Manufacturer
    ZIMMER
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR 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 SURGEON WAS PREPARING TO INSERT THE CUP INTO THE PT WHEN HIS GLOVE CAUGHT THE POROUS FIBER METAL THROUGH THE PLASTIC WRAP. THIS CONTAMINATED THE PRODUCT BY CUTTING THROUGH HIS SURGICAL GLOVE. HE THEN REMOVED THIS IMPLANT FROM THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY SHELL WITH CLUSTER HOLES LPH ZIMMER 62079971

    Patients

    Seq Age Sex Outcome Treatment
    1