The manufacturer became aware of a study from ¿university of pittsburgh school of medicine, pittsburgh¿ which was published in may-2015.The title of this study is ¿tibiotalocalcaneal arthrodesis using retrograde intramedullary nail fixation: comparison of patients with and without diabetes mellitus¿ and is associated with the stryker t2 ankle arthrodesis nail.Within that publication, post-operative complications/ adverse events were reported, which occurred between 1-jan-2005 until 30-jun-2013.It was not possible to ascertain specific device details from the report, a review of the complaint handling database, however, revealed that the event has not been reported by the hospital or by the author of the publication, therefore 68 complaint was initiated retrospectively for the different adverse event mentioned in the report.This product inquiry addresses below-the-knee amputation because of symptomatic nonunion with hardware failure and chronic pain.2 out of 2 cases.The study states: ¿of the 5 patients in our series who subsequently required below-the-knee amputation, 2 did so because of symptomatic nonunion with hardware failure and chronic pain and 3 because of persistent deep infection.¿.
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