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 ¿the implant is well-fixed and well-aligned.It looks good in all aspects.There is a ankylosis between the fibula and the talus, which prevents the ankle joint from moving.¿ based on the investigation the root cause can be attributed to the patient related issue.The failure was caused by ankylosis(bone bridge) between the fibula and the talus which prevents the ankle joint from moving.Also, the implant is assessed as well fixed and well aligned by the hcp.If device is returned or any further information is provided, the investigation report will be reassessed.
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