BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER TRIATHLON TIBIAL BEARING INSERT

    MDR report key: 5196919 · Received October 27, 2015

    Report

    Report Number
    MW5057599
    Event Type
    Injury
    Date Received
    October 27, 2015
    Date of Event
    May 20, 2014
    Report Date
    October 28, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TOTAL KNEE REPLACEMENT ON (B)(6) 2014, 15 WEEKS OF PT AND 6 MONTHS OF EXERCISE, KNEE IS PAINFUL, SWOLLEN, UNSTEADY WALKING, MOBILITY DIFFICULTY, CANNOT WALK MORE THAN 30 YARDS WITHOUT SIGNIFICANT PAIN. SWELLING AND OBVIOUS FLUID BUILDUP ON LEFT SIDE OF RIGHT KNEE. PAIN ON TOP OF KNEE. IMPACTING MY OCCUPATION AND QUALITY OF LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711595 STRYKER TRIATHLON TIBIAL BEARING INSERT TIBIAL BEARING INSERT JWH STRYKER ORTHOPAEDICS MMNPNL
    711596 STRYKER TRIATHLON PATELLA PATELLA JWH STRYKER ORTHOPAEDICS 59Y7

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| S