首页 | 本学科首页   官方微博 | 高级检索  
     


Adverse events involving hallux metatarsophalangeal joint implants: Analysis of the United States Food and Drug Administration data from 2010 to 2018
Authors:Craig C. Akoh  Jie Chen  Rishin Kadakia  Young Uk Park  Hyongnyun Kim  Samuel B. Adams
Affiliation:1. Duke University Medical Center, Box 2887, Durham, NC 27710, United States;2. Department of Orthopedic Surgery, Ajou University Hospital, Ajou University School of Medicine, Suwon, Gyeonggido, Republic of Korea;3. Department of Orthopedic Surgery, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea
Abstract:
BackgroundThe prevalence of osteoarthritis of the hallux metatarsophalangeal joint (MTPJ) is 1 in 40 people over the age of 50. Surgical treatment options for MTPJ arthritis include joint preservation, joint resurfacing, and arthrodesis. Hallux MTPJ implants have evolved over the past several decades, but are associated with various complications. The aim of this study was to examine the MAUDE database to determine reported adverse events for hallux MTPJ implants.Materials and methodsThe US Food and Drug Administration’s (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was reviewed from 2010 to 2018 to review voluntary reported adverse event reports for approved implants within the United States. We recorded the type of adverse event and excluded duplicate reports and those extracted from already published literature.ResultsAmong 64 reported hallux MTPJ implant adverse events, the most common modes of adverse events were component loosening (34%), infection (14.1%), component fracture (9.4%), inflammation (9.4%), and allergic reaction (7.8%). Regarding implant type, Cartiva SCI had the highest percentage of adverse events (23.4%), followed by Arthrosurface ToeMotion (20.3%), Ascension MGT (12.5%), Arthrosurface HemiCAP® (10.9%), Futura primus (9.4%), and Osteomed Reflexion (6.3%). There was an increase in reported adverse events after 2016. The MAUDE database does not report the total incidence of implant insertion.ConclusionOur study of the MAUDE database demonstrated that component loosening and infection are the most common modes of adverse events for hallux MTPJ implants. Cartiva accounted for one-fourth of the implant-related adverse events during our study period, followed by ToeMotion, and Ascension MGT implants. Continued reporting of adverse events will improve our understanding on short and long-term complications of various hallux MTPJ implants.Level of evidenceLevel IV; Case Series from Large Database Analysis; Treatment Study.
Keywords:Metatarsophalangeal joint implants  Failure  Recall  MAUDE database  Loosening  Cartiva
本文献已被 ScienceDirect 等数据库收录!
设为首页 | 免责声明 | 关于勤云 | 加入收藏

Copyright©北京勤云科技发展有限公司  京ICP备09084417号