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.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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 inspection of the x-ray's has shown that those are in a poor quality, based on this we are not able to do any statement.A inspection of the received picture has shown that the three explanted articles are visible, as tibial tray, talar dome and poly.The implants visible do not show any signs of a malfunction.Based on this we are not able to do any further statement.A review of the device history for the reported lot did not indicate any abnormalities.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 re-assessed.
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