BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT CONSTRAINED INSERT

    MDR report key: 1911258 · Received November 23, 2010

    Report

    Report Number
    2249697-2010-01590
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 1, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    P960047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADD'L INFO BECOMES AVAILABLE THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    X RAYS OF WHAT APPEARED TO BE DISLOCATED CONSTRAINED LINER EXAMINED ON 1ST OCTOBER. MFR REOPERATED ON 05 NOVEMBER TO REMOVE WHAT WAS A CONSTRAINED INSERT THAT HAD SEPARATED FROM THE TRIDENT HEMISPHERICAL SHELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT CONSTRAINED INSERT IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA 349MHD

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R