BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORNIER

    MDR report key: 1953919 · Received December 15, 2010

    Report

    Report Number
    9610667-2010-00017
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    November 9, 2010
    Report Date
    December 15, 2010
    Manufacturer
    TORNIER INC.
    Product Code
    HSN
    PMA / PMN Number
    K060544
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT IS REPORTED THAT A PATIENT WITH ABOUT A THREE YEAR OLD ANKLE PROSTHESIS HAS DEVELOPED BONE CYST IN THE SURGICAL ZONE NOW ENCROACHING ON THE AREA OF THE IMPLANT PLATE COMPONENT OF UNKNOWN ETIOLOGY. AN PRE-EXISTING ADDITIONAL BONE CYST WAS IDENTIFIED PREOPERATIVELY IN 2008. A CASUAL RELATIONSHIP BETWEEN THE IMPLANT AND THE NEW CYST FORMATION HAS NOT BEEN IDENTIFIED. A REVISION SURGERY WAS PERFORMED TO EXPOSE AND BIOPSY THE NEW CYST TO RULE OUT SEPSIS AND/OR PERIOSTEUM INFLAMMATION. THE (B)(4) TIBIAL INSERT COMPONENT ORIGINALLY IMPLANTED WAS EXCHANGED WITH A NEW UNIT OF THE SAME CATALOG NUMBER DURING THE REVISION SURGERY. ADDITIONAL REVISION SURGERY AT THIS SITE MAY BE REQUIRED DEPENDING ON THE OUTCOME OF THE BIOPSY - NOT REPORTED TO DATE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORNIER PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL HSN TORNIER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization