Foot & Ankle Orthopaedics (Oct 2020)

Adverse Events Involving Hallux Metatarsophalangeal Joint Implants: Comprehensive Analysis of US Food and Drug Administration Data from 2010 to 2018

  • Craig C. Akoh MD,
  • Rishin J. Kadakia MD,
  • Jie Chen MD, MPH,
  • Young-uk Park MD, PhD,
  • Hyong Nyun Kim MD, PhD,
  • Juntao Wang MD, PhD,
  • Samuel B. Adams MD

DOI
https://doi.org/10.1177/2473011420S00094
Journal volume & issue
Vol. 5

Abstract

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Category: Midfoot/Forefoot; Other Introduction/Purpose: The prevalence of osteoarthritis of the hallux metatarsophalangeal joint (MTPJ) is estimated to affect 1 in 40 people over the age of 50. Surgical treatment options for MTPJ arthritis include joint preservation, joint resurfacing, and salvage arthrodesis. Arthroplasty of the great toe MTPJ has evolved over the past several decades. The aims of this study were to examine the MAUDE database to determine reported adverse events for hallux MTPJ arthroplasty. Methods: The US Food and Drug Administration’s (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was reviewed from 2010-2018 to determine reported adverse events for approved implants. We recorded and categorized the type of adverse event and excluded duplicate reports and those extracted from already published literature. Results: Among 64 unique hallux MTPJ implant adverse events, the most common modes of failure were component loosening (34%), component fracture (9.4%), inflammation (9.4%), infection (14.1%), and allergic reaction (7.8%). In regards to implant type, synthetic implants (Cartiva) 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%). The number of adverse events reported increased substantially after 2016. Conclusion: Our 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. Given that the adverse events for hallux MTPJ implants are underreported, improved reporting mechanisms should be utilized to improve our understanding on long-term effects of various hallux MTPJ implants.