The associated complaint devices were not returned for evaluation.On post op day one after a total hip arthroplasty, it was reported that the patient died due to natural causes.Additional clinical information related to this case has been requested but not provided.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of complaint history on the reported parts revealed no additional complaints for the listed batches.Without the patient¿s medical history, comorbidities, and other relevant medical information, the root cause of the patient¿s demise cannot be determined.Based on a review of the limited details provided with this case, a causal relationship between the device and the reported death cannot be established.If additional relevant supporting documents are received, this case can be re-evaluated.No further clinical assessment is warranted at this time.However, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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