The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.Device disposition is unknown.
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The manufacturer became aware of a post market clinical follow-up report received from university of kansas hospital, in usa.The title of this report is ¿a retrospective data collection of the treatment of the ankle with the t2 ankle arthrodesis nailing system¿ which is associated with the stryker ¿t2 ankle arthrodesis nailing¿ system.This report includes research done on 127 patients between the period april, 2019 and january, 2020.It was not possible to ascertain specific device details from the report, or to match the events reported with previously reported complaints.Therefore, new complaints were initiated in the system for the post-operative complications mentioned in the report.This product inquiry addresses discomfort over anterior tibia and ankle, cortical reaction in anterior tibia cortex and nonunion of the tibiotalar joint followed by nail removal with revision of tibitalar joint with another implant.The report states: ¿(b)(6) year old female with a past medical history of rheumatoid arthritis and coronary artery disease who initially underwent a right total ankle arthroplasty in 2010 which was converted to a tibiotalocalcaneal fusion with a stryker t2 ankle arthrodesis nail (10x200mm nail) secondary to progressive subtalar arthritis and cystic degeneration of the talus in february, 2017.She did well postoperatively however developed discomfort over the anterior tibia and ankle as well as a cortical reaction in the anterior tibial cortex.This was deemed secondary to a stress riser proximally from her nail.A ct scan was obtained in august, 2017 which was significant for fusion of the subtalar joint, however there appeared to be nonunion of the tibiotalar joint.She underwent intramedullary nail removal with revision tibiotalar fusion using another implant in september, 2017.¿.
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