BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINITY

    MDR report key: 3324674 · Received August 23, 2013

    Report

    Report Number
    3324674
    Event Type
    Malfunction
    Date Received
    August 23, 2013
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    CORIN U.S.A.
    Product Code
    MEH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS DEFECTIVE. DEFECTIVE CUP 52MM SIZE 3 CLUSTER SHELL HOLES STRIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413537 TRINITY PROTHESIS, HIP MEH CORIN U.S.A. 321.03.352 237575

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR