Correction - h6 (device, method, results, and clinical code).The reported event could be confirmed since images of ct scans were provided and matches the alleged failure mode.There are many clinical factors that can affect the results of any surgery, such as surgical technique, pre-operative and post-operative care, the implant, patient pathology and daily activity.A medical professional reviewed the received information and noted the following: ¿the revised primary planning showed a bone void in the distal tibia.The ct-scan of the revision planning shows a bone void in the central distal part of the tibia, adjacent to the tibial component, including the posterior peg.This is not fixed to the bone anymore.Furthermore, there¿s a radiolucent line between the tibial implant and the bone, suspect of beginning of loosening.The anterior pegs, however, are still fixed to the bone.The pe-liner looks intact, as far as i can tell on a ct-scan.The retrieval is needed for a definitive assessment.The talar component is intact and well-fixed to the bone.It has subsided slightly anteriorly and there is osteopenia of the talus.The reason for revision most likely is the beginning of the tibial component loosening and the bone void.Clinical information is needed to make a definitive assessment (pain, joint motion, infection and more).¿ more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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