BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PS

    MDR report key: 2861366 · Received December 7, 2012

    Report

    Report Number
    1020279-2012-00662
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    October 24, 2011
    Report Date
    November 30, 2012
    Manufacturer
    SMITH & NEPHEW, INC.
    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 A REVISION WAS PERFORMED DUE TO DISASSOCIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PS LGN PS HIGH FLEX XLPE SZ 5-6 13MM JWH SMITH & NEPHEW, INC. 10EM08404

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention TIBIAL INSERT| (B)(4)| OXINIUM FEMORAL IMPLANT