The associated reflection 3 hole shell, reflection liner, anthology ps high offset stem and cobalt chrome femoral head were not returned for evaluation.Therefore a product analysis could not be performed.However, device details were provided.Consequently, the review of 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.The review of the complaint history for 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.There is no information that would suggest the implanted devices failed to meet specifications.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.A clinical analysis noted that based on the study information this was not revised but just reduced.The patient has since died 4 years later and there is no indication that this was related to the smith and nephew devices or the dislocations 4 years prior.No clinical relevant information has been provided for inclusion in this investigation.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.
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