BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT 0 DEG INSERT 36MM

    MDR report key: 1850020 · Received September 27, 2010

    Report

    Report Number
    2249697-2010-01285
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 3, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K062419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DURING THE THA, THE TRIDENT 0 DEG INSERT DID NOT LOCK INTO THE TRIDENT CUP. THEREFORE, HE IMPLANTED OTHER INSERT INSTEAD OF IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 0 DEG INSERT 36MM IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA MJKHE7

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other