Jeremy S Somerson1, Jason E Hsu2, Moni B Neradilek3, Frederick A Matsen4. 1. Department of Orthopaedic Surgery and Rehabilitation, University of Texas Medical Branch, Galveston, TX, USA. 2. Department of Orthopaedics and Sports Medicine, University of Washington, Seattle, WA, USA. 3. The Mountain-Whisper-Light Statistics, Seattle, WA, USA. 4. Department of Orthopaedics and Sports Medicine, University of Washington, Seattle, WA, USA. Electronic address: matsen@uw.edu.
Abstract
BACKGROUND: Most of the literature on shoulder arthroplasty failure comes from high-volume centers. These reports tend to exclude the experience of community orthopedic surgeons, who perform most of the shoulder joint replacements. METHODS: We analyzed the failure reports mandated by the US Food and Drug Administration for all hospitals. Each reported event from 2012 to 2016 was characterized by implant, failure mode, and year of surgery. RESULTS: For the 1673 anatomic arthroplasties, the most common failure modes were glenoid component failure (20.4%), rotator cuff/subscapularis tear (15.4%), pain/stiffness (12.9%), dislocation/instability (11.8%), infection (9%), and humeral component loosening (5.1%). For the 2390 reverse arthroplasties, the most common failure modes were dislocation/instability (32%), infection (13.8%), glenosphere-baseplate dissociation (12.2%), failed/loosened baseplate (10.4%), humeral component dissociation/tray fracture (5.5%), difficulty inserting the baseplate (4.8%), and difficulty inserting the glenosphere (4.2%). Although the percentage distribution among the different failure modes was relatively consistent over the years of this study, the percentage distribution of these failure modes differed substantially among different implant manufacturers. CONCLUSIONS: The Food and Drug Administration database reveals modes of shoulder arthroplasty failure that are not emphasized in the published literature, such as rotator cuff tear, infection, and postoperative pain/stiffness for anatomic total shoulder arthroplasty and implant dissociation and baseplate failure for reverse shoulder arthroplasty. Knowledge of these failure modes may help inform surgical technique and implant design in ways that will lower the risk of implant failure in the future.
BACKGROUND: Most of the literature on shoulder arthroplasty failure comes from high-volume centers. These reports tend to exclude the experience of community orthopedic surgeons, who perform most of the shoulder joint replacements. METHODS: We analyzed the failure reports mandated by the US Food and Drug Administration for all hospitals. Each reported event from 2012 to 2016 was characterized by implant, failure mode, and year of surgery. RESULTS: For the 1673 anatomic arthroplasties, the most common failure modes were glenoid component failure (20.4%), rotator cuff/subscapularis tear (15.4%), pain/stiffness (12.9%), dislocation/instability (11.8%), infection (9%), and humeral component loosening (5.1%). For the 2390 reverse arthroplasties, the most common failure modes were dislocation/instability (32%), infection (13.8%), glenosphere-baseplate dissociation (12.2%), failed/loosened baseplate (10.4%), humeral component dissociation/tray fracture (5.5%), difficulty inserting the baseplate (4.8%), and difficulty inserting the glenosphere (4.2%). Although the percentage distribution among the different failure modes was relatively consistent over the years of this study, the percentage distribution of these failure modes differed substantially among different implant manufacturers. CONCLUSIONS: The Food and Drug Administration database reveals modes of shoulder arthroplasty failure that are not emphasized in the published literature, such as rotator cuff tear, infection, and postoperative pain/stiffness for anatomic total shoulder arthroplasty and implant dissociation and baseplate failure for reverse shoulder arthroplasty. Knowledge of these failure modes may help inform surgical technique and implant design in ways that will lower the risk of implant failure in the future.
Authors: Mohammad Ghoraishian; Brian W Hill; Thema Nicholson; Matthew L Ramsey; Gerald R Williams; Surena Namdari Journal: Shoulder Elbow Date: 2020-10-25
Authors: Marine Coste; Vineet Aggarwal; Neil V Shah; David Kim; Omar K Hariri; Louis M Day; Scott C Pascal; Jaydev B Mistry; William P Urban; William R Aibinder; Arvind G Von Keudell; Nishant Suneja Journal: Arch Bone Jt Surg Date: 2021-07
Authors: Sarav S Shah; Benjamin T Gaal; Alexander M Roche; Surena Namdari; Brian M Grawe; Macy Lawler; Stewart Dalton; Joseph J King; Joshua Helmkamp; Grant E Garrigues; Thomas W Wright; Bradley S Schoch; Kyle Flik; Randall J Otto; Richard Jones; Andrew Jawa; Peter McCann; Joseph Abboud; Gabe Horneff; Glen Ross; Richard Friedman; Eric T Ricchetti; Douglas Boardman; Robert Z Tashjian; Lawrence V Gulotta Journal: JSES Int Date: 2020-09-07
Authors: Bradley S Schoch; Thomas W Wright; Joseph D Zuckerman; Pierre-Henri Flurin; Charlotte Bolch; Chris P Roche; Joseph J King Journal: JSES Open Access Date: 2019-11-18