Correction - h6 results code.The reported event could not be confirmed since the device was not returned for evaluation and the images provided does not match the alleged failure mode.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.A medical professional reviewed the received information and noted the following: ¿on the ct-scan the tibial shows signs of a slight anterior subsidence, without signs of loosening.The talar tray looks fine.There¿s just a slight subsidence of the anterior side of the tibial tray with good osteointegration of the component.There do not seem to be radiological signs that would indicate a revision.There is no clinical information, thus other reasons for revision (i.E., instability, lack of rom etcetera) and patient-related factors that may have contributed to such an indication cannot be assessed.¿ 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 did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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