BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY BCS

    MDR report key: 2210829 · Received August 12, 2011

    Report

    Report Number
    1020279-2011-00320
    Event Type
    Injury
    Date Received
    August 12, 2011
    Report Date
    August 12, 2011
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL SURGERY WAS PERFORMED IN (B)(6) 2010, AND REVISION SURGERY WAS PERFORMED IN (B)(6) 2011. EXACT DATES WERE NOT PROVIDED.

    Description of Event or Problem · 1

    A REVISION WAS REPORTED DUE TO PAIN, SWELLING AND BUCKLING AROUND THE KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOURNEY BCS JOURNEY FEM OX NP BCS RT SZ 6 JWH SMITH & NEPHEW ORTHOPAEDICS 74021116

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4)