Correction - h6 (device code, results code and 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 ¿the talus is showing radiolucence and very large cysts adjacent to the component, loosening is likely, but there is no clear sign of migration.¿ based on the investigation the root cause can be attributed to the patient related issue.The failure was caused due to radiolucency and large cysts adjacent to the talus component and hence loosening is confirmed by the hcp.If device is returned or any further information is provided, the investigation report will be reassessed.
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