The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿reported device related adverse effects: the most commonly reported adverse effects associated with the star ankle are the following: pain and nerve injury, mobile bearing fracture, device loosening (tibial plate, talar component), instability, device subsidence.Potential adverse effects: the following adverse effects may occur in association with total ankle replacement surgery including the star ankle: device failure, dislocation, loosening of any of the components, fatigue fracture of the implants, heterotopic bone formation, adverse effects may necessitate reoperation, revision, arthrodesis of the involved ankle, and/or amputation of the ankle, increased ankle pain and/or reduced ankle function.¿ 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.If device is returned or any further information is provided, the investigation report will be reassessed.
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