Analysis of FDA-approved orthopaedic devices and their recalls

Journal of Bone and Joint Surgery - American Volume

Volumn 98, Issue 6, 2016, Pages 517-524

  Day, Charles S ^a,b   Park, David J ^a,c   Rozenshteyn, Frederick S ^a,c   Owusu Sarpong, Nana ^a,c   Gonzalez, Aldebarani ^a  

^a BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^b HARVARD MEDICAL SCHOOL   (United States)

^c TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANESTHESIA; CARDIOVASCULAR PROCEDURE; DEVICE APPROVAL; DEVICE RECALL; DIAGNOSIS; FOOD AND DRUG ADMINISTRATION; GENERAL HOSPITAL; HUMAN; ONCOLOGY; ORTHOPEDIC EQUIPMENT; ORTHOPEDICS; PRIORITY JOURNAL; REVIEW; SURGERY; DEVICES; EQUIPMENT DESIGN; ORTHOPEDIC SURGERY; POSTMARKETING SURVEILLANCE; UNITED STATES;

DEVICE APPROVAL; EQUIPMENT DESIGN; HUMANS; MEDICAL DEVICE RECALLS; ORTHOPEDIC EQUIPMENT; ORTHOPEDIC PROCEDURES; PRODUCT SURVEILLANCE, POSTMARKETING; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84977188220     PISSN: 00219355     EISSN: 15351386     Source Type: Journal    
DOI: 10.2106/JBJS.15.00286     Document Type: Review

References (26)

1. Dhruva SS, Redberg RF. FDA regulation of cardiovascular devices and opportunities for improvement. J Interv Card Electrophysiol. 2013 Mar;36(2):99-105. Epub 2012 Dec 21.
2. U.S. Food and Drug Administration. Regulatory controls. 2014 Jun 26. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/default.htm. Accessed 2015 Nov 12.
3. U.S. Food and Drug Administration. Premarket Notification 510(k). 2015 Sep 16. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm. Accessed 2015 Nov 30.
4. U.S. Food and Drug Administration. Premarket Approval (PMA). 2014 Aug 19. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/default. htm. Accessed 2015 Nov 30.
5. U.S. Government Accountability Office. FDA should take steps to ensure that high-risk device types are approved through the most stringent premarket review process. 2009 Jan. http://gao.gov/new.items/d09190.pdf. Accessed 2015 Nov 12.
6. Rome BN, Kramer DB, Kesselheim AS. FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012. JAMA. 2014 Jan 22-29;311(4):385-91.
7. Ardaugh BM, Graves SE, Redberg RF. The 510(k) ancestry of a metal-on-metal hip implant. N Engl J Med. 2013 Jan 10;368(2):97-100.
8. Feigal DW, Gardner SN, McClellan M. Ensuring safe and effective medical devices. N Engl J Med. 2003 Jan 16;348(3):191-2.
9. U.S. Food and Drug Administration. Recalls, corrections and removals (devices). 2014 Oct 30. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/RecallsCorrectionsAndRemovals/#2. Accessed 2015 May 6.
10. Institute of Medicine. Medical devices and the public's health: the FDA 510(k) clearance process at 35 years. 2011 Jul 29. https://iom.nationalacademies.org/Reports/2011/Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years.aspx. Accessed 2015 Sep 28.
11. Fauber J. Senate launches investigation of Medtronic spine fusion device. 2011 Jun 22. http://abcnews.go.com/Health/medtronic-spine-fusion-device-subject-senate-investigation/story?id=13897739. Accessed 2015 Sep 28.
12. Newswire PR. Stryker hip lawsuit allegations confirmed in new study of Rejuvenate hip implants, Bernstein Liebhard LLP reports. 2014 Apr 14. http://www. prnewswire.com/news-releases/stryker-hip-lawsuit-allegations-confirmed-in-new-study-of-rejuvenate-hip-implants-bernstein-liebhard-llp-reports-255188311.html. Accessed 2015 Sep 28.
13. Meier B. Johnson & Johnson in deal to settle hip implant lawsuits. 2013 Nov 19. http://www.nytimes.com/2013/11/20/business/johnson-johnson-to-offer-2-5-billion-hip-device-settlement.html?-r=0. Accessed 2015 Sep 28.
14. U.S. Food and Drug Administration. Premarket approval (PMA). http://www. accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm. Accessed 2015 Nov 12.
15. U.S. Food and Drug Administration. 510(k) premarket notification. http://www. accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm. Accessed 2015 Nov 12.
16. U.S. Food and Drug Administration. Product classification. http://www. accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm. Accessed 2015 Nov 12.
17. U.S. Food and Drug Administration. PMA review process. 2015 Mar 26. http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketapprovalPMA/ucm047991.htm. Accessed 2015 Nov 12.
18. U.S. Food and Drug Administration. Medical device recalls. 2015 Nov 27. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm. Accessed 2015 Nov 30.
19. Zuckerman DM, Brown P, Nissen SE. Medical device recalls and the FDA approval process. Arch Intern Med. 2011 Jun 13;171(11):1006-11. Epub 2011 Feb 14.
20. Mahomed NN, Syed K, Sledge CB, Brennan TA, Liang MH. Improving the post-market surveillance of total joint arthroplasty devices. Open Rheumatol J. 2008;2:7-12. Epub 2008 Feb 25.
21. Gartland JJ. Orthopaedic clinical research. Deficiencies in experimental design and determinations of outcome. J Bone Joint Surg Am. 1988 Oct;70(9):1357-64.
22. Castro FP Jr, Chimento G, Munn BG, Levy RS, Timon S, Barrack RL. An analysis of Food and Drug Administration medical device reports relating to total joint components. J Arthroplasty. 1997 Oct;12(7):765-71.
23. Mundy A. Political lobbying drove FDA process. 2009 Mar 6. http://www.wsj. com/articles/SB123629954783946701. Accessed 2015 Sep 28.
24. Melnick M. FDA admits it was wrong to approve a knee treatment. Florida. 2010 Oct 14. http://healthland.time.com/2010/10/14/fda-admits-it-was-wrong-to-approve-a-knee-treatment/. Accessed 2015 Sep 28.
25. U.S. Food and Drug Administration. Medical device user fee amendments 2012 (MDUFA III). 2015 Nov 10. http://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ucm20081521.htm. Accessed 2015 Nov 30.
26. U.S. Food and Drug Administration. Birmingham Hip Resurfacing System. 2006. http://www.accessdata.fda.gov/cdrh-docs/pdf4/p040033a.pdf. Accessed 2015 Aug 7.