Correction - h6 (clinical signs code, device code, results code, conclusion code).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 ¿all components intact and well fixed.Most likely stiffness/indication for revision because of extra-articular bridging bone formation.¿ based on investigation, the root cause was attributed to a patient related issue.The failure was caused due to the extra-articular bridging bone formation which most likely resulted in stiffness/indication in the patient.If device is returned or any further information is provided, the investigation report will be reassessed.
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