In a scientific publication, zhang zeng 2017, "a retrospective analysis of the intertan nail and proximal femoral nail anti-rotation in the treatment of intertrochanteric fractures in elderly patients with osteoporosis: a minimum follow-up of 3 years" it was revealed that the patient presented a femoral shaft fracture a medical intervention was required.
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It was reported from a literature study that a patient presented a femoral shaft fracture and a medical intervention was required.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.A clinical evaluation noted that no relevant supporting documentation was provided, therefore a thorough medical investigation could not be performed.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 not limited to bone quality 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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