BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TRIDENT ACETABULAR SYSTEM

    MDR report key: 2922089 · Received January 11, 2013

    Report

    Report Number
    2249697-2013-90102
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS
    Product Code
    JDI
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED THROUGH A ATTORNEY, AS A RESULT OF A LEGAL CLAIM. DUE TO THE ONGOING LITIGATION NO ADD¿L INFO IS AVAILABLE AT THIS TIME. IF ADD¿L INFO IS RECEIVED, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE ATTORNEY FOR THE PATIENT, AS A RESULT OF A LEGAL CLAIM, THAT ALLEGEDLY THE PATIENT RECEIVED A TRIDENT ACETABULAR SYSTEM. IT IS ALLEGED ¿AFTER THE IMPLANTATION OF THE DEVICE, THE PT BEGAN EXPERIENCING SIGNIFICANT PAIN AND DISCOMFORT IN THE AREA OF THE DEVICE AND HAS UNDERGONE PREMATURE REVISION SURGERY TO HAVE IT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18962 UNKNOWN TRIDENT ACETABULAR SYSTEM IMPLANT JDI STRYKER ORTHOPAEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R