Please note corrections to b1, b2, h1, h6 results code and conclusion.The reported event could be confirmed, since the need for a revision could be confirmed based on the received ct-scans.The complaint was forwarded to medical affairs for review with following result: "it was possible to assess the ct-scan for the latest revision planning and read the attached documents.In general, it shows severe osteoporosis with bone void and a coarse and open trabecular structure, indicating very poor bone quality.The tibial implant (inbone) shows radiolucency around it, indicating loosening.It is in procurvatum position.The polyethylene liner looks intact, although this cannot be assessed in detail on ct due to it being radiolucent.The talar component has subsided completely into the bone, leaving almost no remnant talus.It is definitively loose.With the information at hand, it is plausible that the revision is necessary for implant loosening, caused by poor bone quality, being a patient-related issue.Another reason for revision was already stated by the surgeon, being that the tibial component needs to be adjusted out of procurvatum.Without further clinical information, no other patient-related root causes can by assessed." 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.No indications of material, manufacturing or design related problems were found during the investigation.Based on the evaluation of the available information, the root cause was attributed to a patient related issue due to the poor bone quality.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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