The reported event could be confirmed, based on available medical records and assessment of health care professionals.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: after reviewing hcp opinion and surgeon¿s feedback we can conclude that tibial components shows radiolucence and smaller cysts and there is some subsidence as well.Pe seems attached with components, no sign of breakage or separation.The talar component shows radiolucency and large cysts, hence component likely loose and migration cannot be confirmed.Based on investigation, the root cause was attributed to a patient related issue.The failure is detected by the subsidence around tibial components and large cyst around talar component.If device is returned or any further information is provided, the investigation report will be re-assessed.H3 other text : device remains implanted in patient.
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