BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 DEG CONSTRAINED INSERT 22E

    MDR report key: 3870593 · Received June 12, 2014

    Report

    Report Number
    0002249697-2014-02237
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    June 15, 2010
    Report Date
    May 21, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWZ
    PMA / PMN Number
    K061654
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED VIA CLINICAL OUTCOMES REPORTING STUDIES. 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 SURGERY DUE TO INSTABILITY OF THE LEFT TOTAL HIP ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348527 TRIDENT 0 DEG CONSTRAINED INSERT 22E IMPLANT KWZ STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention