The reported event could be confirmed, based on available ct scans 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.A review of the labeling did not indicate any abnormalities.Upon further investigation of the ct scans by healthcare professionals the following was observed since the affected device was not returned and the lot number was not communicated, it is not possible to know according to which revision the product has been manufactured.Upon further investigation of the ct scans by healthcare professionals the following was observed "the tibial construct shows radiolucency, some cysts and there is a subsidence visible.Loosening and migration can be confirmed.No clear separation of pe from the tibial component, there is no breakage in talar dome construct some radiolucency.In comparison to the initial planning the implant looks subsided.It is not unlikely that the relatively short shaft of the inbone component has contributed to a loosening.If that is the case, the incident would at least partly be user/treatment related.However, the main cause for the failure is patient related poor bone substance." based on investigation, the root cause was attributed to a patient related issue.The failure was caused by poor bone substance of patient.If device is returned or any further information is provided, the investigation report will be reassessed.H3 other text : device remains implanted in patient.
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