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 literature published by university of (b)(6).The title of this report is ¿prospective randomized controlled trial of two different intramedullary nails for pertrochanteric fractures of the femur¿ which is associated with the stryker ¿gamma3 nailing¿ system.The article can be found at pubmed with id: 26680399.Within that publication which included 41 patients, post-operative complications were reported, which allegedly occurred from march 2012 to june 2013.It was not possible to ascertain specific device details or patient information 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 (2) cases of deep vein thrombosis which were treated with long-term anti-coagulation therapy.
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