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 department of trauma, hand and reconstructive surgery university of the saarland, in germany.The title of this report is ¿does the implant make the difference? ¿ prospective comparison of two different proximal femur nails¿ which is associated with the stryker ¿gamma3 nailing¿ system.The article can be found with pubmed id: 27682295.This report includes research done on 39 patients between the period from october 2007 to may 2009.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 3 cases of haematomas or seroma.
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