The reported event could be confirmed after evaluation of ct imaging obtained.Upon further investigation of the ct scans by healthcare professionals the following was observed, "the tibial component shows clear radiolucence and some cysts adjacent to the implant.The component is luxated proximal-posteriorly, therefore loosening and migration can be clearly confirmed.Infection cannot be assessed with the ct scan only.There is no information given, that an infection is present in this case." based on investigation, the root cause was attributed to a patient related issue.The event was caused by cyst's and osseointegration issues near the implant resulting in loosening and migration.A review of the labeling did not indicate any abnormalities.A review of the device history was not possible because the lot number was not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.No corrective actions are required at this time.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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