BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT CONSTRAINED INSERT

    MDR report key: 3870625 · Received June 12, 2014

    Report

    Report Number
    0002249697-2014-02233
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    December 25, 2013
    Report Date
    May 21, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWZ
    PMA / PMN Number
    P960047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED VIA (B)(6). AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT MADE AVAILABLE TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REVISION OF THE RIGHT TOTAL HIP ARTHROPLASTY DUE TO PJI (PROSTHETIC JOINT INFECTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348551 TRIDENT CONSTRAINED INSERT IMPLANT KWZ STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention