The complaint could be confirmed, since the information for evaluation matches the alleged failure.Upon further investigation of the ct scans by healthcare professionals the following was observed: the talar component shows clear radiolucence and some cysts and cavities, it looks subsided anteriorly as well.Therefore loosening and migration can be confirmed.Infection cannot be excluded by the ct scan only.However, there is no information given that infection is present.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.Based on investigation, the root cause was attributed to a patient factors issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device remains implanted in patient.
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