Improving the Postmarket Surveillance of Total Joint Arthroplasty Devices



Nizar N Mahomed*, 1, Khalid Syed1, Clement B. Sledge2, Troyen A Brennan3, Matthew H Liang4
1 Division of Orthopaedic Surgery, Toronto Western Hospital, University Health Network, University of Toronto, 399 Bathurst St., ECW 1-002, Toronto, Ontario, Canada M5T 2S8; Clinical Epidemiology and Health Care Research Program, Department of Health Administration, University of Toronto, Canada
2 Department of Orthopedic Surgery, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA
3 Division of Internal Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA
4 Division of Rheumatology, Immunology and Allergy, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA; Section of Rheumatology, VA Boston Health Care System, USA


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2008 Bentham Science Publishers Ltd.

open-access license: This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.5/), which permits unrestrictive use, distribution, and reproduction in any medium, provided the original work is properly cited.

* Division of Orthopaedic Surgery, Toronto Western Hospital, University Health Network, University of Toronto, 399 Bathurst St., ECW 1-002, Toronto, Ontario, Canada M5T 2S8; Tel : (416) 603-5328; Fax: (416) 603-3437; E-mail: nizar.mahomed@utoronto.ca


Abstract

Objective

To evaluate the FDA’s approval process and postmarket surveillance strategies for THR devices.

Design

The FDA Center for Devices and Radiological Health (CDRH) 510k releasable database was used to document approved THR devices. The CDRH Medical Device Reporting data files were used to study the efficiency of the FDA’s post-market surveillance system. Manufacturers were contacted to supply information regarding their implants. Medline was searched between 1966-1996 to determine the percentage of THR devices with published data on clinical outcomes.

Results

Between 1976 and 1996, 701 new THR devices were approved by the Substantial Equivalent (SE) route and 34 were approved on the basis of Premarket Approval PMA. The number of approvals doubled between 1991-1995 compared to 1976-1990. Seventy-four different manufacturers obtained approval to market THR devices. Only four manufacturers obtained approval via the PMA application. Under Mandatory Device Reporting all revision arthroplasties should be reported. Using data from 2 independent services for which we had US hospital discharge data in 1993 we estimate that only 3% of all revision THR were reported to the FDA. Manufacturers of hip implants failed to provide useful information. Medline search revealed only 15% of the approved THR devices had published data on outcomes.

Conclusion

Current FDA premarket approval and postmarket surveillance strategies fail to provide information for evidence-based selection of THR devices. Recommendations are made to avert problems with device failures.