The manufacturer became aware of a literature published by the ¿orthopedic surgery and traumatology service, doctor peset university hospital, spain ¿.The title of this report is ¿randomized prospective study on the influence of the gamma 3 nail¿s distal block on the treatment of pertrochanteric femur fractures ¿, published on 01 january 2015, which is associated with the stryker ¿gamma 3 nailing system¿.The article can be found at http://dx.Doi.Org/10.1016/j.Recot.2014.06.004.This report includes an analysis of the clinical data that was collected on 177 patients.The cases in this study range from june 2011 to january 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 2 patients experienced cut-out, which required revision.The report states, 5 cases of ¿cut-out¿ one of which was a follow-up loss, another one was an asymptomatic patient with low functional demands, who did not want treatment and the rest were operated on by implanting an arthroplasty, a partial in two cases and a complete one in the other case, all of them with cemented components.
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This record is a consolidation of events summarized as part of literature review when device and patient information is not available.This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged event of cut-out, 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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