The manufacturer became aware of a literature published by the ¿department of orthopedics, beijing armed police corps hospital, china¿.The title of this report is, ¿screw plate fixation, intramedullary fixation and artificial femoral head replacement in the repair of femoral intertrochanteric fractures in the elderly: choice and comparison¿, published on april 23, 2015, which is associated with the stryker ¿gamma-3 nailing system¿.The article can be found at https://doi.Org/10.3969/j.Issn.2095-4344.2015.17.016.This report includes an analysis of the clinical data that was collected on 168 patients, and the cases in this study range from june 2005 to june 2010.During the review of the literature, it was not possible to establish a specific device detail, patient information, and currently no additional device information is available.It was reported that 1 patient experienced limb shortening.The report states that, ¿ one of the 27 patients had internal fixation device loosening, one had limb shortening greater than 2 cm, and one had coxa vara¿.
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This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged event of limb shortening could not be confirmed since the device was not returned for evaluation and no other additional information was received from the author.More detailed information about the patient medical history, the event circumstances, radiographs and the involved device(s) must be available in order to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.Device disposition unknown.
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