美国人工膝关节假体召回诉讼事件分析及启示

Analysis of recall lawsuit of artificial knee prosthesis in USA and its enlightenment

人工膝关节置换术是治疗严重膝关节病变的有效手段。随着人工关节理念、产品和技术的不断进步,全球范围内的膝关节置换手术量不断增多。人工膝关节手术疗效与多种因素有关,其中医生的手术技术、患者自身因素以及假体的设计和性能是导致术后早期失败、翻修和患者满意率下降的关键因素。中国人工关节假体设计和生产工艺不断进步,走向国际化、进入国际市场是大势所趋。我国人工关节企业快速顺利进入国际市场尤其是欧美市场,需要持续加强对国外医药法规、法律的理解和强化召回诉讼等不良事件的意识,更要积极提升自身产品设计和生产管理的质量保证体系,不断增强国际间产品技术和管理经验的交流合作,切实提高我国医疗器械在国际化市场的地位。本文回顾近年来美国食品和药物管理局(Food and Drug Administration,FDA)针对人工膝关节假体五大企业主要产品的召回诉讼事件,分析产品召回的原因和产品临床使用不良事件的相关文献,以期为国内临床医务人员及人工膝关节假体生产企业提供参考。

Total knee replacement is an effective method to treat serious knee joint diseases. The rapid development in the technology of artificial knee joints has led to a quickly increasing number of knee replacement surgeries. The clinical results of total knee arthroplasty depend on many factors. These factors include the surgical technique, selection of the patient and design of the prosthesis. Recent development of Chinese artificial knee joints will eventually put these products into the international markets. Before entering the international markets, it is necessary to fully understand the foreign medical regulations and laws, and to prevent from adverse events such as recall litigations, especially in Europe and America. Hence, the quality assurance system of the products and production management system should be promoted. Therefore, the experiences of famous international companies should be used to effectively improve the qualities of Chinese medical devices. The present article reviewed the recent recalls of products of five artificial knee prosthesis enterprises by the Food and Drug Administration (FDA) and analyzed the causes of product recalls and related literatures of adverse events in clinical use.