Correction: h6 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 ¿loosening and significant migration of the tibial tray due to poor bone quality.Patient related issue¿ based on the investigation, the root cause was attributed to the patient related issue.The failure was detected due to poor bone quality of the patient which resulted in loosening and significant migration of the tibial tray and is confirmed from the hcp¿s assessment.If device is returned or any further information is provided, the investigation report will be reassessed.
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