BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOURNEY TOTAL KNEE FEMORAL COMPONENT, TIBIAL COMPONENT, TIBI

    MDR report key: 1800126 · Received July 18, 2010

    Report

    Report Number
    1800126
    Event Type
    Malfunction
    Date Received
    July 18, 2010
    Date of Event
    June 24, 2010
    Report Date
    July 18, 2010
    Manufacturer
    SMITH AND NEPHEW
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD BILATERAL TOTAL KNEE ARTHROPLASTIES DONE IN 2008 AT AN OUTSIDE HOSPITAL (OSH). PATIENT HAS BEEN UNHAPPY WITH THE RESULTS OF HIS LEFT TOTAL KNEE ARTHROPLASTY COMPLAINING OF A SIGNIFICANT FEELING OF INSTABILITY. PATIENT CONDITION WAS IMPROVED WITH A POSTERIOR CRUCIATE LIGAMENT STABILIZATION BRACE. PATIENT WAS OFFERED OPERATIVE INTERVENTION TO IMPROVE THE ANTEROPOSTERIOR STABILITY OF HIS JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOURNEY TOTAL KNEE FEMORAL COMPONENT, TIBIAL COMPONENT, TIBI KNEE ARTHROPLASTIES JWH SMITH AND NEPHEW T 74022226 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR