In a scientific publication, zelle, "safety and efficacy of a two-screw cephalomedullary nail for intertrochanteric femur fracture fixation: a retrospective case series in 264 patients" it was reported that the patient presented a screw cut out, the patient had pre-existing avascular necrosis of the femoral head and, subsequently, underwent hardware removal and total hip arthroplasty at approximately 6 weeks postoperative.
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It was reported from a literature study that the patient presented a screw cut out, the patient had pre-existing avascular necrosis of the femoral head and, subsequently, underwent hardware removal at approximately 6 weeks postop.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 medical analysis noted that based on the literature review, the design of the cephalomedullary nail aims to decrease the risk of failures in patients with intertrochanteric hip fractures.The two-screw cephalomedullary nail, the insertion of a lag screw combined with an interdigitated compression screws were designed to minimize complications such as mechanical failure, screw cut out, varus collapse, shortening of the femoral neck, peri-implant femoral shaft fractures around the distal tip of the implant and to improve patient safety in surgery.The results of the retrospective study confirmed the hypothesis that the innovative two-screw nail is a safe and reliable nailing system for the treatment of patients with intertrochanteric femoral fractures, the nail system had a low cut out and mechanical failure rate.Possible cause could include but is not limited to post-operative healing issues.Based on this investigation, the need for corrective action is not indicated.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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