This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged loss of consolidation of the bone interposition 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.
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The manufacturer became aware of a literature published by the ¿orthopaedic center, máxima medical center, the netherlands ¿.The title of this report is ¿case report: an iatrogenic bleeding of the deep femoral artery ¿, published on october 23, 2015, which is associated with the stryker ¿t2 femoral nailing system¿.The article can be found at doi: 10.17554/j.Issn.2311-5106.2015.02.93.This report includes an analysis of the clinical data that was collected on 1 patient.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 loss of consolidation of the bone interposition.The report states, ¿unfortunately however, the patient required additional treatment as the plate that was used for bone fixation started to loosen.The plate was therefore replaced with a long t2 femoral nail that ended just distal to the knee joint.Five months later, this nail was replaced by an even longer nail as consolidation of the bone interposition had not yet occurred whereas the arthrodesis of the knee joint was incomplete.¿.
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