Correction - b1, h6 (clinical code, device code) the reported event could be confirmed, since evaluation of the ct imaging did find signs of a fracture in the patient's talus.Medical affairs reviewed the available details and the ct imaging.It was noted, "the ct-scan shows a well-placed and well-fixed tibial component, with no signs of loosening or subsidence.The pe-liner looks intact and symmetrical.The talar component is placed relatively close to the inferior side of the talus, leaving little bone stock beneath the component.The ct-scan shows signs of fracture of the talus." there are many clinical factors that can affect the results of any surgery, such as surgical technique, pre-operative and post-operative care, the implant, patient pathology and daily activity.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling was not possible because the catalog number and lot number were not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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