The associated r3 3 hole acetabular shell and reflection spherical head cancellous screws were not made available for investigation.However, device details were provided.Thus, a review of the manufacturing records and complaint history was conducted.The review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of complaint history of the listed parts 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.As devices were not returned for analysis, the failure mode cannot be determined.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.Without the return of the actual products involved, our investigation of this report is inconclusive.Our clinical evaluation noted the provided x-rays confirms the reported issue.A procedural variance, additional trauma, bone quality, body habitus, or comorbidities as contributing factors to the reported event cannot be ruled out.It is currently unknown if the patient is experiencing pain.The future impact to the patient cannot be determined.No further investigation 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.
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