BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT HEMISPHERICAL CLUSTER 54MM

    MDR report key: 3781311 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01613
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    October 13, 2006
    Report Date
    April 9, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K013676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME DUE TO ONGOING LITIGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING LOOSENING INVOLVING A TRIDENT SHELL WAS REPORTED. THE EVENT WAS NOT CONFIRMED. A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION WAS NOT PERFORMED AS THE DEVICE WAS NOT RETURNED. INSUFFICIENT INFORMATION WAS RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. DEVICE HISTORY REVIEW. ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ATTORNEY FOR THE PATIENT AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY THE TRIDENT SHELL LOOSENED AND REQUIRED REVISION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ATTORNEY FOR THE PATIENT AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY THE TRIDENT SHELL LOOSENED AND REQUIRED REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258927 TRIDENT HEMISPHERICAL CLUSTER 54MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 19225401

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R