BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGION

    MDR report key: 2980283 · Received February 27, 2013

    Report

    Report Number
    1020279-2013-00126
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 25, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE WAS RETURNED AND EVALUATED. OUR INVESTIGATION INCLUDED AN ATTEMPT TO PERFORM A DIMENSIONAL INSPECTION OF THE DEVICE; HOWEVER SEVERAL ATTRIBUTES WERE DEFORMED AND COULD NOT BE ACCURATELY MEASURED. THE DEVICE WAS ANALYZED BY OUR RESEARCH AND DEVELOPMENT TEAM. THERE WAS DAMAGE ON THE DISTAL SURFACE OF THE INSERT. THIS DAMAGE ON THE POSTERIOR SURFACE OF THE INSERT MOST LIKELY INDICATES THAT IT WAS RIDING ON TOP OF THE TIBIAL BASE PLATE. THE ANTERIOR LOCK SHOWED DEFORMATION OF THE LOCK UPWARDS, WHICH INDICATES THAT THE INSERT MAY HAVE NEVER FULLY SEATED

    Description of Event or Problem · 1

    REVISION SURGERY WAS PERFORMED. THE CAUSE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84596 LEGION LEGION PS NP FEM SZ 6 RT JWH SMITH & NEPHEW, INC. 12HM09597

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4)| (B)(4)| (B)(4)