Please note correction to h6 (device and health impact codes).The reported event could be confirmed since images of ct scans were provided and shows loosening of the talar component.Upon further investigation of the ct scans by healthcare professionals the following was observed: ¿the talus shows some radiolucence as well, anteriorly and a little bit around the pegs.Loosening is likely, there is no clear sign of migration.¿ based on investigation, the root cause was attributed to a patient related issue.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 reassessed.
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