The reported event could be confirmed since the device was explanted and returned for evaluation.The device inspection revealed the following: visual examination of the returned implant confirms the catalog and lot number.Remnants of biological material could be seen on the talar dome.Scratches and blemishes are visible on the superior side of the talar dome.Key dimensional measurements were taken with a digital caliper and found to be within dimensional specifications.Upon further investigation of the received information by healthcare professionals the following was observed: ¿from the additional information given in this case (failure six weeks after the implantation but no confirmed infection) it can be assumed, that the poor bone stock and additional patient related problems (ra) have contributed to the failure.A different implant would have been chosen by the surgeon-at least that is stated- to prevent the implant from early loosening.¿ based on investigation, the root cause was attributed to a patient related issue.The failure was most likely caused by poor bone stock and the rheumatoid arthritis experienced by the patient.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.
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