The complaint could be confirmed, since the information for evaluation matches the alleged failure.Upon further investigation of the ct scans by healthcare professionals the following was observed: there is a long tibial stem with 4 mid stem parts in it.The implant seems still fixed proximally, but the most distal of the mid stem, the base stem and the tibial tray have large radiolucence with plenty of space, partial loosening can be confirmed by base stem and tibial tray.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 lot number was not communicated.Based on investigation, the root cause was attributed to a patient factors issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device remains implanted in patient.
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