BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL AND TIBIAL COMPONENTS

    MDR report key: 1240503 · Received November 21, 2008

    Report

    Report Number
    1240503
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    June 24, 2008
    Report Date
    November 19, 2008
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT PARTIAL RIGHT KNEE REPLACEMENT IN 2003 HAS BEEN EXPERIENCING INCREASING PAIN. RETURNED TO OR FOR REVISION. IN OR, SIGNIFICANT POLYETHYLENE WEAR AND LOOSENING OF BOTH FEMORAL AND TIBIAL COMPONENTS WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL AND TIBIAL COMPONENTS JWH UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization