BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRI TS BASEPLATE SIZE 4

    MDR report key: 2912728 · Received January 7, 2013

    Report

    Report Number
    2249697-2013-90049
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K053514
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THROUGH THE FILING OF A LAWSUIT THAT THE PATIENT ALLEGES THE RIGHT TRIATHLON KNEE IMPLANTED ON (B)(6) 2011, IS CAUSING KNEE PAIN, PAIN IN THE MUSCLES, INABILITY TO STAND AND WALK, AND LOOSENING OF THE REPLACEMENT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8308 TRI TS BASEPLATE SIZE 4 IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA FOLX

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other