BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT X3 ELEVATED RIM 32MM ID

    MDR report key: 2061232 · Received April 11, 2011

    Report

    Report Number
    2249697-2011-00440
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    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

    IT WAS REPORTED THAT, "PT WAS DISLOCATING SO THE SURGEON REVISED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT X3 ELEVATED RIM 32MM ID IMPLANT LPH STRYKER ORTHOPAEDICS MAHWAH NA 31283801

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other| R