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 division of orthopaedics, department of clinical sciences, karolinska institutet at danderyd hospita in sweden.The title of this report is ¿loss of offset after pertrochanteric hip fractures affects hip function one year after surgery with a short intramedullary nail.A prospective cohort study¿ published on june 24, 2015, which is associated with the stryker ¿gamma3 nailing¿ system.The article can be found at doi 10.1007/s00264-015-2815-6.This report includes research done on 76 patients between the period 2008 to 2010.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 (28) cases of lateral pain at one year.The report states a large compression and lateral protrusion of the collum screw are associated with poorer hip function and lateral pain.
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