BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERAMTEC CERAMIC INS/SLEEVE TRIDENT F

    MDR report key: 1112505 · Received August 7, 2008

    Report

    Report Number
    9616680-2008-00231
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Date of Event
    July 18, 2008
    Report Date
    July 18, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    P000013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ITEM WOULD NOT SEAT INTO THE 56MM SHELL AND HAD TO BE PRYED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CERAMTEC CERAMIC INS/SLEEVE TRIDENT F IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 25415401

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other