The reported event could be confirmed since images of ct scans were provided and shows loosening of the tibial and talar components.Upon further investigation of the ct scans by healthcare professionals the following was observed: ¿the tibia shows clear radiolucence and there are cysts.It is visible, that loosening and migration has occurred as the component is subsided posterior and proximally.The pe cannot be seen directly in the ct scan, but there is no indirect sign of loosening or migration.The talar component shows mild radiolucence and a little bit of condensed bone anteriorly, the talar component seems a little subsided.However, only loosening can be confirmed, while migration is not clearly visible.¿ based on investigation, the root cause was attributed to a patient related issue.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.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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