Correction - h6 (clinical code).The reported event could not be confirmed since the device was not returned for evaluation and imaging provided could not be used to indicate the reason for revision.Medical affairs was consulted on the details of the case.According to their review, "the ct-scan shows well-fixed tibial and talar components.No apparent sign of loosening.Just some bone cyst formation around the talar component.The tibial component is placed quite far laterally, so parts of its lateral side are not supported by bone.The pe-liner looks intact and symmetrical.A retrieval is necessary to confirm this.Clinical information is needed to assess the root cause / indication for revision." 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.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 was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling was not possible because the catalog number and lot number were 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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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