The reported event could be confirmed based on available medical record 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.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Upon further investigation of the ct scans by healthcare professionals the following was observed ¿talar dome and stem subsided together into the talus, no signs of loosening, however.Poor bone quality¿ based on investigation, the root cause was attributed to a patient related issue.The failure was detected due to the poor bone quality of the patient.According to the hcp, the talar dome and stem subsided together into the talus and hence migration is confirmed.If the device is returned or any further information is provided, the investigation report will be reassessed.
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