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 batch 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 the tibial component shows some radiolucence and some subsidence anteriorly.Loosening and migration could be confirmed.Pe seems attached with components, no sign of breakage or separation.The talar component shows radiolucency around pegs, hence loosening and migration could not be confirmed.Based on investigation, the root cause was attributed to a patient related issue.The failure is detected by the radiolucence and subsidence of tibial components and radiolucency around talar pegs.If device is returned or any further information is provided, the investigation report will be reassessed.
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