H3, h6: it was reported that a revision surgery of thr was performed.The biolox forte ceramic liner 36 mm 44g was revised.The reason for the revision surgery is unknown.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.Based on this investigation, the need for corrective action is not indicated.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.A review of risk management files and the instructions for use could not be performed with accuracy as the reason for the revision surgery is unknown.No medical documents were received for investigation as the information will be provided by our legal department.Without the reason for revision surgery or patient medical records available, the potential root cause cannot be determined at this time.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
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