The manufacturer became aware of a literature published by the ¿department of orthopaedic surgery, nihonkai general hospital, japan¿.The title of this report is, ¿prevention of excessive postoperative sliding of the short femoral nail in femoral trochanteric fractures¿, published on march 24, 2015, which is associated with the stryker ¿gamma-3 nailing system¿.The article can be found at http://dx.Doi.Org/10.1007/s00402-015-2200-3.This report includes an analysis of the clinical data that was collected on 400 patients, and the cases in this study range from april 2010 to april 2013.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 cut-out and non-union.The report states that, ¿one cutout (specifically, there was medial migration of the lag screw and perforation of the acetabulum during the 6 months after surgery)¿.The report also states, ¿and one non-union, which was in the cut-out case described above ¿.
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This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged event of cut-out and non-union 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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