A relationship, if any, between the subject bone cement and implant reported event could not be determined since product was not returned.Without supporting clinical/medical documents a thorough investigation cannot be performed.The complaint could not be verified, nor could a root cause be determined with confidence.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This investigation could not verify or identify any evidence of product contribution to the reported problem.Based on this investigation, the need for corrective action is not indicated.If any product associated with this event is returned at a future date, the evaluation will be reopened for investigation.Our investigation including a review of complaint history for the listed product revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Should clinical information become available, a clinical review will be conducted.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate as necessary.Should additional event information be received, the complaint will be reopened and reevaluated.
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