BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON

    MDR report key: 2071400 · Received April 21, 2011

    Report

    Report Number
    MW5020373
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    December 12, 2007
    Report Date
    April 5, 2011
    Manufacturer
    HOWMEDICA OSTEONICS
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TOTAL KNEE REPLACEMENT HAS COME LOOSE. A LOT OF PAIN AND CANNOT BEND LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON TOTAL KNEE SYSTEM, CR FEMORAL COMPONENT #7 LEFT - CEMENTED JWH HOWMEDICA OSTEONICS CE 0086 H3119SDH3L
    2 TRIATHLON TOTAL KNEE SYSTEM, PRIMARY TIBIAL BASEPLATE JWH STRYKER ORTHOPAEDICS CE 0086 WHTJ
    3 TRIATHLON TOTAL KNEE SYSTEM, ASYMMETRIC PATELLA A38 X 11MM JWH HOWMEDICA OSTEONICS CE 0086 H7160LAT866
    4 TRIATHLON TOTAL KNEE SYSTEM, CR TIBIAL INSERT #6 - 11MM JWH HOWMEDICA OSTEONICS CE 0086 G4109LAA819

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Disability