This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.No device or photos were received; therefore the condition of the device is unknown.A device history record review identified no deviations or anomalies during the manufacturing process for both tibial base and talar component.This device is used for treatment.Operative notes state that, "varus-valgus stressing as well as range of motion and stability and alignment of the construct was then confirmed under multiplanar image intensification guidance and confirmed to be appropriately positioned." initial product history search conducted on november 15th 2016 revealed no additional complaints against the related part and lot combination for both tibial base and talar component.A definite root cause cannot be determined with the information provided.
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