It was reported that after the procedure, revision surgery was performed because the patient has a dissociation.The patient has experienced disassociation before this case.The affected device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.No patient information or operative reports have been provided for inclusion in this medical investigation.Therefore no medical assessment can be performed at this time.Based on this investigation, the need for corrective action is not indicated.Possible causes could include but are not limited to fit/sizing, traumatic injury, abnormal motion over time or patient medical conditions.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.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.We consider this investigation closed.
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