Analysis of recall lawsuit of artificial knee prosthesis in USA and its enlightenment / 中华骨科杂志

ABSTRACT

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.