Correction - h6(device 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.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.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 ¿there is radiolucence and subsidence visible in the talus.The implants are loosened and migrated.Due to a lack of clinical information an assessment regarding the underlying cause is limited.¿ 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¿s assessment there is radiolucency and subsidence visible in the talus and the tibia and hence loosening and migration can be confirmed, but due to a lack of clinical information an assessment regarding the underlying cause is limited.If device is returned or any further information is provided, the investigation report will be reassessed.
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