Adverse events related to triplanar 1st tarsometatarsal joint arthrodesis: 5-year analysis of the united states food and drug administration manufacturer and user facility device experience database

Abstract

BackgroundThe Lapiplasty® 3D Bunion Correction™ system represents an instrumented, jig-guided system to facilitate performing triplanar 1st tarsometatarsal joint arthrodesis. Literature available for this system is positive, although the vast majority is from inventor/consultant surgeons. The purpose of this manuscript is to review adverse event submissions recorded in the Manufacturer and User Facility Device Experience database specific to this system. MethodsThe Manufacturer and User Facility Device Experience database was retrospectively reviewed from inception to 30 June 2023 for adverse events submitted for the Lapiplasty® 3D Bunion Correction™ system. Submissions that involved a medical device product other than this system, duplicate entries, and submissions with data extracted from already published literature were excluded. ResultsA total of 180 unique reports that met inclusion criteria during the 5-year period available were reviewed. The mean time between event occurrence and submission was 46.7-days. The most common entity submitting to the database were the manufacturer company representative or distributor in 66.4%. The most frequently encountered patient problems were pain in 41.9%, non-union in 18.2%, and hardware-related irritation in 11.7%. Reports that detailed a revision surgery described partial/complete hardware removal in 62.7% and revision with additional hardware implantation in 23.3%. ConclusionWhile no direct conclusions regarding the Lapiplasty® 3D Bunion Correction™ system can be drawn from the data as it consists of only adverse event reports, this study demonstrates the need for more non-inventor/consultant literature to further investigate adverse events related this particular system.