Correction - h6 (results code and conclusion code).The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.Formal medical opinion was sought an experienced independent medical expert based on available ct scan and primary tar report.His response is as below; ¿the ct-scan shows clear subsidence and migration of the tibial component, the posterior side tilted proximally (upward).It also overhangs the posterior tibial cortex, giving the impression that the tibial component is positioned a few millimeters to far posteriorly.The pe-liner looks intact, however, only examining its retrieval will allow for proper assessment.The talar component looks well-fixed.There is a status after triple arthrodesis (that is fusion of the subtalar, calcaneocuboid and talonavicular joints).The indication for revision most likely is the poor position and possible partial loosening of the tibia implant.Poor bone quality seems to be the patient-related factor in play.¿ based on the available information and medical expert opinion, the root cause of the failure is patient¿s poor bone quality related factor.However, more detailed information about the complaint event as well as the affected device must be available in order to determine the exact 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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