In a scientific publication, zhang zhu 2017, "intertan nail versus proximal femoral nail anti-rotation-asia for intertrochanteric femur fractures in elderly patients with primary osteoporosis" it was reported that the patient presented a malunion and a second operation was required with bone grafting, and bone union was observed 5 to 7 months postoperatively.
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It was reported from a literature study that the patient presented a malunion and a second operation was required with bone grafting, and bone union was observed 5 to 7 months postoperatively.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 medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.Possible causes could include but are not limited to abnormal loading of limb, abnormal motion over time, patient anatomy or post-operative healing issue.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.
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