BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON CR FEM COMP #6 R-CEM

    MDR report key: 4093884 · Received September 16, 2014

    Report

    Report Number
    0002249697-2014-03501
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    July 24, 2012
    Report Date
    July 26, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K141056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS. NO SPECIFIC DEVICE INFORMATION WAS PROVIDED BY THE ATTORNEY. THE DEVICE WAS REPORTED AS AN UNKNOWN TRIATHLON KNEE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PLAINTIFF CONTINUED TO EXPERIENCE PAIN AND COMPLICATIONS FROM THE (B)(6) 2012 SURGERY AND AS A RESULT UNDERWENT ANOTHER REVISION SURGERY ON OR ABOUT (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570853 TRIATHLON CR FEM COMP #6 R-CEM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH SSHLH

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R