Orthopedic Implant Retrieval—Imperatives and Possibilities BRIAN YEAKLEY 1 and TARUN GOSWAMI 1,2 1 Department of Biomedical Industrial and Human Factors Engineering, Wright State University, Dayton, OH 45435, USA; and 2 Department of Orthopaedic Surgery, Sports Medicine, and Rehabilitation, Wright State University, Dayton, OH 45435, USA (Received 25 June 2007; accepted 24 July 2009; published online 5 August 2009) Abstract—Premature orthopedic implant failure occurs for a variety of reasons. In such scenarios implant retrieval is an issue that has a potential for further investigation leading to redesign of components and to improve implant longevity. While strict standards must be adhered to in order to gain FDA approval to use an implant, capturing, and recording the contributing factors leading to explanta- tion and that of retrieved implant is neither strictly adhered to nor enforced. This article presents data illustrating implant standards both pre-market approval as well as in the retrieval scenarios. This paper provides a compilation of specific specifications on implant retrieval handling and storage, compelling imperatives and possibilities at national or global scale. The need for a user-definable, searchable interface is proposed in this paper to facilitate such an important task. Keywords—Implants, Retrieval, Orthopedic surgery, Stan- dards, Wear, Design. INTRODUCTION Projected world population growth, as illustrated in Fig. 1, will continue to drive the overall need for better medical devices. 10,27 The enormous numbers of babies born right after World War II, affectionately known as the Baby Boomers, are now at retirement age with a much greater life expectancy than ever before. The U.S. Department of Labor’s Bureau of Labor Statistics discusses job outlook by engineer- ing specialty. It projects, ‘‘Biomedical engineers are expected to have employment growth that is much faster than the average for all occupations through 2014. The aging of the population and the focus on health issues will drive a demand for better medical devices and equipment designed by biomedical engi- neers.’’ 10 Clearly, with such an expanding orthopedic implant customer base, we must focus on how we can improve the implants and enhance the retrieval and documentation processes. Ultimately, this report develops compelling reasons why a standardized national/global, user-definable, searchable database of orthopedic retrieval information is critically necessary. Globally there are four registries that compile data on total joint replacements. They are the Australian Orthopaedic Association National Joint Replacement Registry, the Canadian Joint Replacement Registry, Swedish Joint Replacement Registry and Norwegian Arthroplasty Registry. Each of the four registries provides quality demographic information on the practice of joint-replacement surgery, outcomes, and establishes a mechanism of audit for hospitals and individual surgeons. Each of the registries is voluntary, yet receives cooperation from all hospitals undertaking joint-replacement surgery. The Norwegian registry provides yearly reports of primary and revision sur- geries and failure modes that lead to dysfunction. These registries also have another function of saving health care costs by improving the design and devel- opment phases of the implant and surgical methods in order to reduce premature failure. The major failure modes were also identified for each of the joint types by these registries. Since this paper focuses on the retrieval issues, the failure modes will not be discussed here. In the United States, The Kaiser Permanente National Total Joint Replacement Registry (TJRR) is a national level database designed as a post-market surveillance system for elective total hip and knee replacement. As of March 31, 2007, the TJRR recorded 16,945 primary total hip arthroplasties (THA), 2144 revisions (11.2%); and 30,815 total knee arthroplasties (TKA), 1794 revisions (5.5%). Given that the total number of joint replacement surgeries performed annually in the U.S. is 20 times or higher than that registered, this gap needs to be bridged. Address correspondence to Tarun Goswami, Department of Orthopaedic Surgery, Sports Medicine, and Rehabilitation, Wright State University, Dayton, OH 45435, USA. Electronic mail: tarun. goswami@wright.edu Annals of Biomedical Engineering, Vol. 37, No. 11, November 2009 (Ó 2009) pp. 2326–2336 DOI: 10.1007/s10439-009-9766-2 0090-6964/09/1100-2326/0 Ó 2009 Biomedical Engineering Society 2326