The complaint could be confirmed, since the information for evaluation matches the alleged failure.Medical profession reviewed the received information and noted: left ankle joint, inbone tar in situ.The tibial component consists of the described components: - inbone tibial top stem, inbone tibial base stem, and inbone tibial tray left.All components are intact and there are no signs of component dissociation.The component is surrounded by a radiolucent line, suspect of loosening.There are cystic changes in the adjacent tibial bone.The - inbone poly sz4+ 10mm sulcus looks intact, as far as can be assessed on a ct-scan.The talar component, consisting of inbone talar dome sz4 sulcus, and inbone talar stem are intact without signs of component dissociation.The component has subsided laterally and is surround by significant degenerative bone changes (cysts) in the talus.There are degenerative changes in the adjacent subtalar and talonavicular joints.Whether these are symptomatic cannot be assessed without clinical information.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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