Correction - please refer to h6 (results & conclusion codes).The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Ct imaging was available for review.Upon further investigation of the ct scans by healthcare professionals the following was observed, ¿the tibia shows a component with negligible radiolucency around the pegs.There is no sign of loosening or migration visible.The pe cannot be assessed directly with the ct scan, however, there is no indirect sign of loosening or migration as well.The talar component also shows a little bit of radiolucency around the peg, but the body of the component seems to be firmly integrated.There are bony structures around the talar component indicating the described, talar osteophytes.These structures interfere with the tibial component and may negatively impact the function of the tar.The components are intact, but due to the periprosthetic osteophytes around the talar component the function is limited." a review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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