The reported event could not 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.Failure of total ankle replacement (tar) over time is a known complication.In case of a planned revision procedure a medical opinion is part of the internal investigation process.Sufficient (radiological and clinical) information must be provided to enable a proper full clinical assessment and to identify possible causes of failure.In cases where a ct scan is the only available clinical source the informative value and the assessment of the underlying potential cause of a failure is severely limited.In the vast majority of these cases no conclusive statement can be provided, because the accompanying clinical information (e.G.Clinical status, exact symptoms and range of motion of the patient) is missing.Radiographic findings such as radiolucent areas and bone cysts may indicate potential problems, but their clinical significance remains uncertain without the additional context.Due to the limited information and clinical context, we therefore refrain from making definitive statements about the patient, the procedure and/or the device in relation to the failure.Upon further investigation of the ct scans by healthcare professionals the following was observed ¿no conclusive statement can be provided.There is some radiolucence visible around the tibial component.The talar implant shows some radiolucence as well.There is no clear statement possible regarding loosening or migration of the components.No conclusive statement can be given without further clinical information regarding the underlying cause or the relation to the device.¿ more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.According to the hcp, there is some radiolucency visible around the tibial and the talar component.But no clear statement is possible regarding loosening or migration of the components and without further clinical information, no conclusive statement can be given regarding the underlying cause or the relation to the device in this case.If device is returned or any further information is provided, the investigation report will be reassessed.
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