Correction: g1 manufacturing site for devices, h6 (results & conclusion codes).The reported event was confirmed since images of ct scans were provided and shows loosening of the talar component.Upon further investigation of the ct scans by healthcare professionals the following was observed: ¿the talar component shows little radiolucence as well.There are also some cysts.Loosening can be confirmed, migration is not proofed by the provided information, though.¿ based on investigation, the root cause was attributed to a patient related issue.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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