BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORNIER

    MDR report key: 2024072 · Received March 11, 2011

    Report

    Report Number
    9610667-2011-00010
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    January 17, 2011
    Report Date
    March 11, 2011
    Manufacturer
    TORNIER INC.
    Product Code
    JWH
    PMA / PMN Number
    K013906
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE EVENT REPORTED OCCURRED IN (B)(6) WITH A TORNIER DEVICE WHICH IS ALSO USA DISTRIBUTED. A KNEE PROSTHESIS INITIALLY IMPLANTED WITHIN 2002, PRECISE DATE UNKNOWN, REQUIRED REVISION SURGERY TO REPLACE A WORN POLYETHELYNE INSERT COMPONENT. THE DEVICE HAS NOT BEEN RETURNED AS YET. ADDITIONAL CLINICAL INFORMATION THAT HAS BEEN REQUESTED HAS NOT BEEN RECEIVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORNIER PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL JWH TORNIER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention