BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN TRIDENT CONSTRAINED LINER

    MDR report key: 1017427 · Received March 19, 2008

    Report

    Report Number
    2249697-2008-00070
    Event Type
    Malfunction
    Date Received
    March 19, 2008
    Date of Event
    February 15, 2008
    Report Date
    February 25, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS STILL IMPLANTED. NO EVAL WILL BE PERFORMED. IF THE DEVICE OR ADD'L INFO BECOMES AVAILABLE, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "ON 02/2008, X-RAY SHOWED A BREAK IN OUTER RING ON THE CONSTRAINED LINER. ACCORDING TO THE DR, THE PT IS ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN TRIDENT CONSTRAINED LINER IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other