BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY CUP POSITIONER

    MDR report key: 2994269 · Received February 28, 2013

    Report

    Report Number
    MW5029231
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    September 4, 2012
    Report Date
    February 28, 2013
    Manufacturer
    ZIMMER
    Product Code
    HWA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY. DURING THE INSERTION OF THE ACETABULAR SHELL, THE INSERTER/ IMPACTOR TIP LOOSENED- THERE WAS A MALFUNCTION OF THE ACETABULAR CUP PLACEMENT SCREW. A DECISION WAS MADE NOT TO REMOVE THE ACETABULAR SHELL, AS IT WAS WELL FIXED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85703 TRILOGY CUP POSITIONER IMPACTOR HWA ZIMMER 61845476

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR