The manufacturer became aware of a literature published by the ¿department of orthopaedic surgery, st.Vincent¿s hospital, the catholic university of korea, republic of korea ¿.The title of this report is ¿additional use of anti-rotation u-blade (rc) decreases lag screw sliding and limb length inequality in the treatment of intertrochanteric fractures ¿, published on august 31, 2021, which is associated with the stryker ¿gamma 3 nailing system¿.The article can be found at https://doi.Org/10.1038/s41598-021-96988-z.This report includes an analysis of the clinical data that was collected on 152 patients.The cases in this study range from january 2014 to december 2018.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 non-union, which required revision.The report states, ¿non-union, a well-known but rare complication, occurred in one patient in the u-blade gamma3 group.Revision bipolar hemiarthroplasty was performed after removal of the nail.¿.
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This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged event of nonunion, which required revision, 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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