It was reported that a revision surgery was performed due to infection.The affected complaint devices, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.As device details were not made available, device history record, complaint history and sterilization documentation review cannot be completed.To date no medical records have been received on this complaint.There is no information that would suggest the devices failed to meet specifications.A relationship, if any, between the devices and the reported incident could not be corroborated.Without any supporting medical documentation, a thorough medical assessment cannot be performed.Infection, a potential complication associated with any surgery, can occur and possible causes could include but are not limited to contamination, patient reaction, and post-operative healing issue.Without the return of the actual product involved and no patient medical records provided, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, this complaint will be reopened and reevaluated.
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