Analysis of 4063 complications of shoulder arthroplasty reported to the US Food and Drug Administration from 2012 to 2016

Journal of Shoulder and Elbow Surgery - Tập 27 Số 11 - Trang 1978-1986 - 2018
Jeremy S. Somerson1, Jason E. Hsu2, Moni B. Neradilek3, Frederick A. Matsen2
1Department of Orthopaedic Surgery and Rehabilitation, University of Texas Medical Branch, Galveston, TX, USA
2Department of Orthopaedics and Sports Medicine, University of Washington, Seattle, WA, USA
3The Mountain-Whisper-Light Statistics, Seattle, WA, USA

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Black-Maier, 2017, Risk of atrioesophageal fistula formation with contact-force sensing catheters, Heart Rhythm, 14, 1328, 10.1016/j.hrthm.2017.04.024

Bohsali, 2017, Complications of shoulder arthroplasty, J Bone Joint Surg Am, 99, 256, 10.2106/JBJS.16.00935

Bourgault, 2017, Cortrak-assisted feeding tube insertion: a comprehensive review of adverse events in the MAUDE Database, Am J Crit Care, 26, 149, 10.4037/ajcc2017369

Chen, 2016, Morbidity and mortality associated with robotic head and neck surgery: an inquiry of the Food and Drug Administration Manufacturer and User Facility Device Experience Database, JAMA Otolaryngol Head Neck Surg, 142, 405, 10.1001/jamaoto.2015.3673

Connor, 2017, Adverse events involving radiation oncology medical devices: comprehensive analysis of US Food and Drug Administration data, 1991 to 2015, Int J Radiat Oncol Biol Phys, 97, 18, 10.1016/j.ijrobp.2016.08.050

Day, 2016, Analysis of FDA-approved orthopaedic devices and their recalls, J Bone Joint Surg Am, 98, 517, 10.2106/JBJS.15.00286

Day, 2010, Prevalence and projections of total shoulder and elbow arthroplasty in the United States to 2015, J Shoulder Elbow Surg, 19, 1115, 10.1016/j.jse.2010.02.009

Dillon, 2017, Yearly trends in elective shoulder arthroplasty, 2005-2013, Arthritis Care Res (Hoboken), 69, 1574, 10.1002/acr.23167

Favard, 2013, Revision of total shoulder arthroplasty, Orthop Traumatology, 99S, S12

Hasan, 2003, The distribution of shoulder replacement among surgeons and hospitals is significantly different than that of hip or knee replacement, J Shoulder Elbow Surg, 12, 164, 10.1067/mse.2003.23

Health Center for Devices and Radiological Health

Health Center for Devices and Radiological Health

Hebballi, 2015, The dangers of dental devices as reported in the FDA MAUDE Database, J Am Dent Assoc, 146, 102, 10.1016/j.adaj.2014.11.015

Kim, 2011, Increasing incidence of shoulder arthroplasty in the United States, J Bone Joint Surg Am, 93, 2249, 10.2106/JBJS.J.01994

Koch, 2016, Spontaneous fractures of a modern modular uncemented femoral stem, HSS J, 12, 250, 10.1007/s11420-016-9510-z

Nussbaum, 2004, A review of complications associated with vertebroplasty and kyphoplasty as reported to the Food and Drug Administration medical device related web site, J Vasc Interv Radiol, 15, 1185, 10.1097/01.RVI.0000144757.14780.E0

Padegimas, 2015, Future patient demand for shoulder arthroplasty by younger patients: national projections, Clin Orthop Relat Res, 473, 1860, 10.1007/s11999-015-4231-z

Riedel, 2010, Evaluation of the learning curve for reverse shoulder arthroplasty, Orthopedics, 33, 237, 10.3928/01477447-20100225-09

Somerson, 2017, Is there evidence that the outcomes of primary anatomic and reverse shoulder arthroplasty are getting better?, Int Orthop, 41, 1235, 10.1007/s00264-017-3443-0

Somerson, 2016, Distribution of high-volume shoulder arthroplasty surgeons in the United States: data from the 2014 Medicare Provider Utilization and Payment data release, J Bone Joint Surg Am, 98, e77, 10.2106/JBJS.15.00776

U.S. Food and Drug Administration

U.S. Food and Drug Administration

U.S. Food and Drug Administration

U.S. Food and Drug Administration

Weinheimer, 2017, Patient outcomes as a function of shoulder surgeon volume: a systematic review, Arthroscopy, 33, 1273, 10.1016/j.arthro.2017.03.005

Westermann, 2015, Reverse shoulder arthroplasty in the United States: a comparison of national volume, patient demographics, complications, and surgical indications, Iowa Orthop J, 35, 1

Woo, 2012, Recombinant human bone morphogenetic protein-2: adverse events reported to the Manufacturer and User Facility Device Experience database, Spine J, 12, 894, 10.1016/j.spinee.2012.09.052

Woo, 2013, Adverse events after recombinant human BMP2 in nonspinal orthopaedic procedures, Clin Orthop Relat Res, 471, 1707, 10.1007/s11999-012-2684-x