1 frequently asked questions Knee and Hip Joint Replacement Technology
2 frequently asked questions Knee and Hip Joint Replacement Technology Recently, you may have seen advertisements from legal companies regarding total joint implant recalls with an emphasis on receiving financial compensation. You may have also seen advertisements from a medical device manufacturer claiming to have a 30-year knee. Biomet would like to give you some facts about total joint replacement to assist you when speaking with an orthopedic surgeon. It is important to ask your surgeon about any concerns you have regarding the device, the surgical procedure, rehabilitation after surgery, the number of surgeries he/she has performed, expectations after surgery, and any other concerns you might have. Recalls If you have a concern about your implant, it is best to call your orthopedic surgeon rather than assume that your implant is part of a current recall. Your surgeon s office will help you verify the manufacturer of your device.
3 Implant Longevity Regarding the advertisements from a medical device company claiming to offer a 30-year knee, Biomet would like to elaborate on this claim to help you understand the factors that affect implant longevity and why joint implant companies do not offer guarantees on implants. While the advertisement does not make a direct guarantee for the longevity of the implant, it implies that the implant lasts 30 years. What Affects Knee and Hip Implant Longevity? Advertisements touting a specific number of years an implant can be expected to last are misleading. How slowly an implant wears is just one of the factors that can determine implant longevity. While implant durability (resistance to wear) is important, patients need to consider many additional factors, such as the ones listed below, when deciding to have joint replacement surgery. Materials Knee and hip replacement devices are made from several different metals, plastics, and ceramics. Different manufacturers use different materials in their implants, and while they may seem similar, their properties can be very different. Technology New materials, manufacturing techniques, and input from orthopedic surgeons help device manufacturers offer the latest technology to improve their implants. New technology doesn t have the benefit of long-term clinical results. Design Most implant design updates are incremental changes to long-standing designs but sometimes the designs are entirely new. Some implants offer more options than others, including: º Various sizes, modular components to accommodate unique patient anatomy, porous coatings to allow for fixation between implants and bone, and many others. Surgical Technique The way a joint replacement device is implanted can affect how long it will last. Improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions that may lead to subsequent reduction in the service life of the device. Malalignment of the components or inaccurate implantation can lead to excessive wear and/or failure of the implant or procedure. Inadequate wound cleaning (removal of surgical debris) can lead to excessive wear. Patient-related Factors Excessive activity (e.g., running, high-impact sports), trauma (e.g., falls, car accidents), changes to bone or muscle, poor overall health, and weight gain have been implicated with premature failure of the implant by loosening, fracture, and/ or wear.
4 Why Don t Joint Implant Companies Offer Warranties on Their Implants? Orthopedic device manufacturers do not offer warranties for knee and hip implants because there are so many factors that can affect longevity. Biomet joint replacement prostheses provide the surgeon with a means of reducing pain and restoring function for a majority of patients. While these devices are generally successful in attaining these goals, implant devices are not designed to withstand excessive activity like running or high-impact sports, trauma, weight gain, or other factors beyond what is acceptable after joint replacement. In addition, compliance with practices in postoperative care are important. Failure of the patient to follow postoperative care instructions involving rehabilitation can compromise the success of the procedure. The Success of Total Joint Replacement Every year, over 1,000,000 people in the United States have joint replacement. While joint replacement doesn t work for everyone, this surgery has been reported to help many patients return to work, activity, and an active lifestyle. Joint replacement treats debilitating pain and deformity, helping to restore movement and, for many patients, quality of life. Studies show that joint replacement intervention can improve quality of life. In a study of hip replacement patients, nearly all patients working prior to surgery return to the workforce, and nearly 50% of those not working pre-operatively regained employment. For those who did not return to work, the reasons were unrelated to their hip condition. 1,2 Total knee replacements are 90% effective in relieving pain and improving function. 3 Knee and Hip replacements can improve patients ability to perform daily tasks and may restore them to pain-free mobility. 4,5 Joint replacements can be cost-effective treatments. Total joint replacement can save an individual as much as $68,000 (total knee replacement) to $180,000 (total hip replacement) in medical costs over the life of the average total joint recipient as compared to non-surgical treatment. 6,7 Some of Biomet s joint replacement implants have published clinical data indicating survivorship rates as high as 98% at years post-operation These results, however, do not guarantee that any implant will last for a specified time period. Joint replacement is an underutilized intervention, and the need for joint replacement technology will only increase. Despite clear value and benefit, only 9 13% of knee replacement candidates, and fewer than 25% of hip replacement candidates, undergo the procedure. 3,4
5 What are the risks of joint replacement? Knee and Hip Replacement While uncommon, complications can occur during and after surgery. Some complications include, but are not limited to, infection, blood clots, implant breakage, malalignment, dislocation, unresolved pain and premature wear, any of which can require additional surgery. Although implant surgery is extremely successful in most cases, some patients still experience stiffness and pain. No implant will last forever and factors such as the patient s post-surgery activities and weight can affect longevity. Be sure to discuss these and other risks with your surgeon. For additional information about Biomet hip and knee implants, including risks and warnings, talk to your surgeon and see the full, device-specific patient risk information on Biomet.com. References 1. Ritter MA, et al., Life expectancy after total hip arthroplasty, J. Arthroplasty, December, Mobasheri R., et al., The Effect of Total Hip Replacement on the Employment Status of Patients Under the Age of 60, Annals of The Royal College of Surgeons of England., March NIH Consensus Panel, 2003, as quoted in Phase I Final Report (Part C): Effects of Advanced Medical Technologies Musculoskeletal Diseases, Medical Technology Assessment Working Group, Duke University Center for Demographic Studies, January 31, George, LK, et al., The Effects of Total Hip Arthroplasty on Physical Functioning in the Older Population, Journal of the American Geriatric Society, June George LK, et al., The effects of total knee arthroplasty on physical functions in the older population, Arthritis Rheum, October, Chang RW, Pellissier, JM, Hazen GB, A Cost-effective Analysis of Total Hip Arthroplasty for Osteoarthritis of the Hip, Journal of the American Medical Association (JAMA), Vol. 275, No.11, 1996, pp Figures apply to average 60 year old patient and adjusted for inflation. 7. Gottlob C., AAOS Presentation #114, Figures apply to average 70 year old patient and adjusted for inflation. 8. Marshall A, et al., Cementless titanium tapered wedge femoral stem: year follow up, Journal ofarthroplasty, (5):546-52, Ritter M, et al., Twenty-year follow-up of the AGC total knee arthroplasty, Journal of Arthroplasty, 23 (2): Price A., et al., 20 year survival and 10 year clinical results of the Oxford Medial UKA, 73rd Annual AAOS Meeting, Chicago IL, McLaughlin J., et al., Total hip arthroplasty with an uncemented tapered femoral component, JBJS 90- A(6), 2008.
6 Biomet is a manufacturer of orthopedic implants and does not practice medicine. This brochure was prepared in conjunction with a licensed physician and is presented as general information only. Only an orthopedic surgeon can determine what treatment is appropriate. Individual results of total joint replacement may vary. The life of any implant will depend on your weight, age, activity level, and other factors. For more information on risks, warnings, and possible adverse effects, see the Patient Risk Information section found within Biomet.com. Always ask your doctor if you have any questions regarding your particular condition or treatment options. biomet.com HCI REV021511
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