Advertisement
Journal of Shoulder and Elbow Surgery

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

      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.

      Level of evidence

      Keywords

      To read this article in full you will need to make a payment

      References

        • Black-Maier E.
        • Pokorney S.D.
        • Barnett A.S.
        • Zeitler E.P.
        • Sun A.Y.
        • Jackson K.P.
        • et al.
        Risk of atrioesophageal fistula formation with contact-force sensing catheters.
        Heart Rhythm. 2017; 14: 1328-1333
        • Bohsali K.I.
        • Bois A.J.
        • Wirth M.A.
        Complications of shoulder arthroplasty.
        J Bone Joint Surg Am. 2017; 99: 256-269
        • Bourgault A.M.
        • Aguirre L.
        • Ibrahim J.
        Cortrak-assisted feeding tube insertion: a comprehensive review of adverse events in the MAUDE Database.
        Am J Crit Care. 2017; 26: 149-156
        • Chen M.M.
        • Holsinger F.C.
        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. 2016; 142: 405-406
        • Connor M.J.
        • Marshall D.C.
        • Moiseenko V.
        • Moore K.
        • Cervino L.
        • Atwood T.
        • et al.
        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. 2017; 97: 18-26
        • Day C.S.
        • Park D.J.
        • Rozenshteyn F.S.
        • Owusu-Sarpong N.
        • Gonzalez A.
        Analysis of FDA-approved orthopaedic devices and their recalls.
        J Bone Joint Surg Am. 2016; 98: 517-524
        • Day J.S.
        • Lau E.L.
        • Ong K.L.
        • Williams G.R.
        • Ramsey M.D.
        • Kurtz S.M.
        Prevalence and projections of total shoulder and elbow arthroplasty in the United States to 2015.
        J Shoulder Elbow Surg. 2010; 19: 1115-1120
        • Dillon M.T.
        • Chan P.H.
        • Inacio M.C.
        • Singh A.
        • Yian E.H.
        • Navarro R.A.
        Yearly trends in elective shoulder arthroplasty, 2005-2013.
        Arthritis Care Res (Hoboken). 2017; 69: 1574-1581
        • Favard L.
        Revision of total shoulder arthroplasty.
        Orthop Traumatology. 2013; 99S: S12-S21
        • Hasan S.S.
        • Leith J.M.
        • Smith K.L.
        • Matsen III, F.A.
        The distribution of shoulder replacement among surgeons and hospitals is significantly different than that of hip or knee replacement.
        J Shoulder Elbow Surg. 2003; 12: 164-169
        • Health Center for Devices and Radiological Health
        Classify your medical device: download product code classifications files.
        (U.S. Food and Drug Administration)
        • Health Center for Devices and Radiological Health
        Mandatory reporting requirements: manufacturers, importers and device user facilities - Manufacturer and User Facility Device Experience Database—(MAUDE).
        (U.S. Food and Drug Administration)
        • Hebballi N.B.
        • Ramoni R.
        • Kalenderian E.
        • Delattre V.F.
        • Stewart D.C.L.
        • Kent K.
        • et al.
        The dangers of dental devices as reported in the FDA MAUDE Database.
        J Am Dent Assoc. 2015; 146: 102-110
        • Kim S.H.
        • Wise B.L.
        • Zhang Y.
        • Szabo R.M.
        Increasing incidence of shoulder arthroplasty in the United States.
        J Bone Joint Surg Am. 2011; 93: 2249-2254
        • Koch C.N.
        • Mateo L.S.
        • Kayiaros S.
        • Cassidy K.A.
        • Jerabek S.A.
        • Gonzalez Della Valle A.
        Spontaneous fractures of a modern modular uncemented femoral stem.
        HSS J. 2016; 12: 250-254
        • Nussbaum D.A.
        • Gailloud P.
        • Murphy K.
        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. 2004; 15: 1185-1192
        • Padegimas E.M.
        • Maltenfort M.
        • Lazarus M.D.
        • Ramsey M.L.
        • Williams G.R.
        • Namdari S.
        Future patient demand for shoulder arthroplasty by younger patients: national projections.
        Clin Orthop Relat Res. 2015; 473: 1860-1867
        • Riedel B.B.
        • Mildren M.E.
        • Jobe C.M.
        • Wongworawat M.D.
        • Phipatanakul W.P.
        Evaluation of the learning curve for reverse shoulder arthroplasty.
        Orthopedics. 2010; 33: 237-241
        • Somerson J.S.
        • Neradilek M.B.
        • Hsu J.E.
        • Service B.C.
        • Gee A.O.
        • Matsen III, F.A.
        Is there evidence that the outcomes of primary anatomic and reverse shoulder arthroplasty are getting better?.
        Int Orthop. 2017; 41: 1235-1244
        • Somerson J.S.
        • Stein B.A.
        • Wirth M.A.
        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. 2016; 98: e77
        • U.S. Food and Drug Administration
        MAUDE—Manufacturer and User Facility Device Experience.
        (Silver Springs, MD: U.S. Food and Drug Administration)
        • U.S. Food and Drug Administration
        Medical device recalls.
        (Silver Springs, MD: U.S. Food and Drug Administration)
        • U.S. Food and Drug Administration
        Medical devices and the public's health: the FDA 510(k) clearance process at 35 years.
        • U.S. Food and Drug Administration
        United States Food, Drug and Cosmetic Act, 1938.
        • Weinheimer K.T.
        • Smuin D.M.
        • Dhawan A.
        Patient outcomes as a function of shoulder surgeon volume: a systematic review.
        Arthroscopy. 2017; 33: 1273-1281
        • Westermann R.W.
        • Pugely A.J.
        • Martin C.T.
        • Gao Y.
        • Wolf B.R.
        • Hettrich C.M.
        Reverse shoulder arthroplasty in the United States: a comparison of national volume, patient demographics, complications, and surgical indications.
        Iowa Orthop J. 2015; 35: 1-7
        • Woo E.J.
        Recombinant human bone morphogenetic protein-2: adverse events reported to the Manufacturer and User Facility Device Experience database.
        Spine J. 2012; 12: 894-899
        • Woo E.J.
        Adverse events after recombinant human BMP2 in nonspinal orthopaedic procedures.
        Clin Orthop Relat Res. 2013; 471: 1707-1711

      Linked Article

      • Response to Weber and McFarland regarding: “Analysis of 4063 complications of shoulder arthroplasty reported to the US Food and Drug Administration from 2012 to 2016”
        Journal of Shoulder and Elbow SurgeryVol. 29Issue 8
        • Preview
          We thank Drs. Weber and McFarland for their thoughtful discussion of our article and for emphasizing the shortcomings of the US Food and Drug Administration (FDA) MAUDE (Manufacturer and User Facility Device Experience) database. As they point out, (1) MAUDE does not provide a denominator by which the complication rates can be calculated; (2) there is no control on the quality of data put into MAUDE; and (3) it is likely that many, if not most, adverse outcomes are not reported to MAUDE.
        • Full-Text
        • PDF
      • Letter to the Editor regarding Somerson et al: “Analysis of 4063 complications of shoulder arthroplasty reported to the US Food and Drug Administration from 2012 to 2016”
        Journal of Shoulder and Elbow SurgeryVol. 29Issue 8
        • Preview
          We read with interest the article by Somerson et al, “Analysis of 4063 complications of shoulder arthroplasty reported to the US Food and Drug Administration from 2012 to 2016.”7 The authors are to be applauded for their efforts to identify complications of shoulder arthroplasty in the real world environment. This study was described as the first analysis of shoulder arthroplasty failure using the then current FDA Manufacturer and User Facility Device Experience (MAUDE) database. The authors compared their study of 4063 shoulder arthroplasty complications (1673 anatomic and 2390 reverse) reported to the FDA for the years from 2012 to 2016 with those in a recent review by Bohsali et al2 analyzing 1009 shoulder arthroplasty complications (345 anatomic and 664 reverse) identified in articles published in the 10 years from 2006 to 2015. The authors concluded that “the FDA database reveals modes of shoulder arthroplasty failure that are not emphasized in the published literature.”7 The limitations of the use of this database described in the article were modest, involving only lack of standardization of data entry, possibly overweighting patients who experienced multiple failure modes, and an inability to ascribe the exact etiology of the failure mode (ie, surgeon error vs.
        • Full-Text
        • PDF