H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical evaluation concluded that the journey ii cr clinical study reports a patient developed cellulitis with redness and swelling of the right knee and leg.The patient was admitted to hospital for antibiotics.Eventually the event resolved without long term problems.Home physical therapy and medication were also prescribed.The clinical study report forms were provided for review, however they did not reveal a root cause for the cellulitis event.It has been communicated that no further medical documentation would be forthcoming.Smith and nephew has not received adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of sterilization documents indicated that the product was sterilized according to sterilization release documentation.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Infection, a potential complication associated with any surgery, can occur and possible causes could include but not limited to contamination, patient reaction, and post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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