Correction - d1 (product long description), h6 (clinical codes, device code, results code and conclusion code).The reported event could be confirmed, based on available medical record and health care professionals.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.A review of the labeling did not indicate any abnormalities.Upon further investigation of the ct scans by healthcare professionals the following was observed: there is radiolucence, subsidence and a periprosthetic fracture visible in the ct scan.The implant is loosened and has migrated together with the pe.The tibial implant is also subsided and migrated inferior-posteriorly, there is radiolucence and cysts and a fracture visible at the posterior end of the talus.Based on investigation, the root cause was attributed to a patient related issue.The cause of failure is due to radiolucence and cavities around tibial and talar components.Also, facture in talus was observed.If the device is returned or any further information is provided, the investigation report will be reassessed.
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