The complaint could be confirmed, since the returned information for evaluation matches the alleged failure.Medical profession reviewed the received information and noted: apparently the adaptis talar component did not show osteointegration with the bone, except for the pegs.From the moment the undersurface is loose, and the pegs are not, then all joint forces acting on the talar component will be transmitted to the surface-peg-junction.These pegs are not designed to withstand these kinds of forces and will eventually break.Since we do not have information on the implantation (talar surface preparation, initial fit of the implant, bone quality, and other patient related factors that may influence osteointegration), a definitive root cause analysis can not be made (yet).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.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.There are many clinical factors that can affect the results of any surgery, such as surgical technique, pre-operative and post-operative care, the implant, patient pathology and daily activity.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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