Correction - h6 (results code and conclusion code).The reported event could be confirmed, based on available information, ct scans and medical expert opinion.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.Upon further investigation of the ct scans by healthcare professionals the following was observed tibial (construct): the tibial tray shows significant radiolucence and some small cysts.Loosening is likely and a little bit of subsidence seems to have occurred.Pe: the pe is not separated from the tibial tray.There is no loosening or breakage visible.Talar (construct): the talar component shows clear radiolucence and very large instable anterior cysts.The component is loosened and anteriorly migrated/subsided.Based on investigation, the root cause was attributed to a patient related issue.The failure was identified by radiolucency and cysts which contributed to subsidence of the tibial and talar construct.If device is returned or any further information is provided, the investigation report will be reassessed.
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