H10: it was reported that after a bilateral total hip replacement surgery performed (only one is from smith and nephew) on (b)(6) 2010, the clinical subject passed away on (b)(6) 2020.The device, used in treatment, was not returned for investigation as it is still in the corpse.A product evaluation could therefore not be performed.A review of the production documentation for the batch in scope was performed and did not reveal any deviation from the standard operating procedure.No further complaints for the batch in scope were reported so far.Hence, there is no indication that the device failed to match specification at the time of manufacturing.A review of past corrective actions was performed as well.No further escalation is required.The patient died 10 years after the implantation of the complained device and the cause of death is unknown.There is no indication that the implant contributed in any manner to the death of the patient.A risk management review and a review of the device labeling were performed, death is not anticipated from the intended use of the device.A thorough medical assessment could not be performed due to limited information available.The provided information offers no insight into the reported death.Should any additional relevant supporting medical information be provided, this compliant would be re-assessed.Based on the available information it is not possible to speculate about factors which could have contributed to the reported event.The cause of the patient¿s death, 10 years after a bilateral total hip replacement surgery remains unknown.Based on the performed investigations, a relationship between the reported event and the device cannot be confirmed.No further actions are deemed necessary.Smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information be received.Internal complaint reference number: (b)(4).
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