The reported event could be confirmed, based on available ct scans and medical expert assessment.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): there is clear radiolucence visible and loosening can be confirmed.There is no sign of migration, though.Pe: the pe is not separated from the tibial component.There is no sign of loosening or migration.Talar (construct): the talar component shows a little radiolucence, but neither loosening nor migration can be confirmed." based on investigation, the root cause was attributed to a patient related issue.The failure was most likely caused due to poor bone stock.If device is returned or any further information is provided, the investigation report will be reassessed.
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