BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CR

    MDR report key: 2990979 · Received March 6, 2013

    Report

    Report Number
    1020279-2013-00147
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSERT DISSASSOCIATED REQUIRING A REVISION SURGERY TO CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95324 CR LGN CR HIGH FLEX XLPE SZ 5-6 9MM JWH SMITH & NEPHEW, INC. 12JM05442

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention