An event regarding revision involving a duracon insert was reported.The event was not confirmed.Method and results: device evaluation and results: the device was not received a photograph of the explanted insert component was received.The photograph is poor quality, therefore it is difficult to inspect the component.There is damage on the component whereby a section of what appears to be one of the posterior compartments of the insert.It is not known how this damage occurred, it may have occurred during explantation.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: review indicated there have been no other events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.It was reported that a revision surgery was performed and the insert component was exchanged however the reason for the revision was not specified.Pain was reported, however pain can occur for a number of reasons and is a symptom rather than the cause of the issue the patient is experiencing.Additional information, including device evaluation, operative reports, progress notes, x-rays are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
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