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机器人辅助关节置换术相关的不良事件:对美国食品和药物管理局 MAUDE 数据库的分析。

Adverse Events Associated With Robotic-Assisted Joint Arthroplasty: An Analysis of the US Food and Drug Administration MAUDE Database.

机构信息

Department of Orthopaedic Surgery, Tufts Medical Center, Boston, MA.

Department of Orthopedic Surgery, Rush University Medical Center, Chicago, IL.

出版信息

J Arthroplasty. 2022 Aug;37(8):1526-1533. doi: 10.1016/j.arth.2022.03.060. Epub 2022 Mar 21.

Abstract

BACKGROUND

The use of robotic assistance in arthroplasty is increasing; however, the spectrum of adverse events potentially associated with this technology is unclear. Improved understanding of the causes of adverse events in robotic-assisted arthroplasty can prevent future incidents and enhance patient outcomes.

METHODS

Adverse event reports to the US Food and Drug Administration Manufacturer and User Facility Device Experience database involving robotic-assisted total hip arthroplasty (THA), total knee arthroplasty (TKA), and partial knee arthroplasty were reviewed to determine causes of malfunction and related patient impact.

RESULTS

Overall, 263 adverse event reports were included. The most frequently reported adverse events were unexpected robotic arm movement for TKA (59/204, 28.9%) and retained registration checkpoint for THA (19/44, 43.2%). There were 99 reports of surgical delay with an average delay of 20 minutes (range 1-120). Thirty-one cases reported conversion to manual surgery. In total, 68 patient injuries were reported, 7 of which required surgical reintervention. Femoral notching (12/36, 33.3%) was the most common for TKA and retained registration checkpoint (19/28, 67.9%) was the most common for THA. Although rare, additional reported injuries included femoral, tibial, and acetabular fractures, MCL laceration, additional retained foreign bodies, and an electrical burn.

CONCLUSION

Despite the increasing utilization of robotic-assisted arthroplasty in the United States, numerous adverse events are possible and technical difficulties experienced intraoperatively can result in prolonged surgical delays. The events reported herein seem to indicate that robotic-assisted arthroplasty is generally safe with only a few reported instances of serious complications, the nature of which seems more related to suboptimal surgical technique than technology. Based on our data, the practice of adding registration checkpoints and bone pins to the instrument count of all robotic-assisted TJA cases should be widely implemented to avoid unintended retained foreign objects.

摘要

背景

关节置换术中使用机器人辅助技术的情况越来越多;然而,与这项技术相关的不良事件的范围尚不清楚。更好地了解机器人辅助关节置换术中不良事件的原因,可以预防未来的事件并改善患者的预后。

方法

对美国食品和药物管理局制造商和用户设施设备体验数据库中涉及机器人辅助全髋关节置换术(THA)、全膝关节置换术(TKA)和部分膝关节置换术的不良事件报告进行了回顾,以确定故障原因及其对患者的影响。

结果

共纳入 263 份不良事件报告。最常报告的不良事件是 TKA 时出现意外的机械臂运动(59/204,28.9%)和 THA 时出现的注册检查点残留(19/44,43.2%)。99 例报告手术延迟,平均延迟 20 分钟(范围 1-120 分钟)。31 例报告转为手动手术。总共报告了 68 例患者受伤,其中 7 例需要再次手术干预。TKA 中最常见的股骨切迹(12/36,33.3%)和 THA 中最常见的注册检查点残留(19/28,67.9%)。虽然罕见,但还有其他报告的损伤包括股骨、胫骨和髋臼骨折、MCL 撕裂、额外的残留异物以及电烧伤。

结论

尽管在美国机器人辅助关节置换术的应用日益增多,但仍可能出现多种不良事件,术中遇到的技术困难可能导致手术时间延长。本文报告的事件似乎表明,机器人辅助关节置换术通常是安全的,只有少数报告的严重并发症,其性质似乎更多地与手术技术不佳有关,而不是技术本身。根据我们的数据,在所有机器人辅助 TJA 病例中,应广泛采用添加注册检查点和骨钉作为器械计数的做法,以避免意外残留的异物。

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