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 (b)(6) medical center, in usa.The title of this report is ¿a retrospective data collection of the treatment of femur fractures with the t2 femoral nailing system¿ which is associated with the stryker ¿t2 femoral nailing system¿.This study includes research done on 52 patients requiring surgery between the period february 15, 2017 to september 1, 2019.It was not possible to ascertain specific device details from the report, or to match the events reported with previously reported complaints.Therefore, new complaint was initiated in the system for the post-operative complication mentioned in the report.This product inquiry addresses significant leg swelling and deep vein thrombosis for which patient was placed on anticoagulation.The report states: ¿patient ten, after undergoing intramedullary rodding of the left femur, presented 6-weeks postoperatively with significant leg swelling and was diagnosed with deep vein thrombosis.They were then placed on anticoagulation.The thrombosis has since been resolved.¿.
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