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.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.Upon further investigation of the ct scans by healthcare professionals the following was observed tibial components are intact and no disassembly can be observed.Ct-scan suggest there was a periprosthetic medial malleolar tibial fracture.It has healed, it may have contributed to the lack of osseointegration of the tibial construct.No signs of gross wear of pe observed.Large bone cysts close to the talar implant observed but the component is intact well.Talar component is well fixed.Based on investigation, the root cause was attributed to a patient related issue.The failure was caused by poor bone stock and loss of integration due to a periprosthetic medial malleolar tibial fracture.Although it has healed, it may have contributed to the lack of osseointegration of the tibial construct.Also, in the information shared by surgeon that the patient continued weight bearing during fracture healing, further explains the incomplete osseointegration.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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