BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUS VKS

    MDR report key: 1841982 · Received September 23, 2010

    Report

    Report Number
    9613369-2010-00051
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    October 6, 2008
    Report Date
    September 23, 2010
    Manufacturer
    SMITH&NEPHEW, AARAU SWITZERLAND MANUFACTURING SITE
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO LOOSENING OF THE TIBIAL COMPONENT. THE CEMENT DID NOT COMPLETELY ADHERE TO THE TIBIAL COMPONENT. INITIAL IMPLANTATION WAS IN (B)(6) 2005, AND THE REVISION WAS PERFORMED (B)(6), 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUS VKS TIBIAL BASEPLATE JWH SMITH&NEPHEW, AARAU SWITZERLAND MANUFACTURING SITE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R