Correction - h6 (clinical signs code and device code).The reported event could be confirmed, based on available medical records and health care professionals.The evaluation of ct scans by our medical affairs could not confirm the device pegs was broken.The device inspection was not possible as the product was not returned for investigation.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.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 the tibial component shows some radiolucence and some cysts.Component is dislocated.Loosening and migration could be confirmed.Pe seems attached with components, no sign of breakage or separation.The talar component shows some radiolucence and some artifacts which do not allow clear assessment of pegs.Loosening and migration anteriorly could be confirmed.Based on investigation, the root cause was attributed to a patient related issue.The failure is detected by the radiolucence and migration of tibial and talar component.If device is returned or any further information is provided, the investigation report will be reassessed.
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