Problems with ATTUNE include loosening of the tibial component at the implant-cement interface within the first two years after implant. Pain and instability are among the clearest early warnings of knee replacement loosening. The FDA approved it through the agency’s 510(k) clearance process. If there is a problem with the Depuy Attune knee replacement system, it could potentially affect thousands of individuals. Copyright © 2016-2020 Consumer Safety Watch. For more information, visit our sponsors page. In June 2015, the U.S. Food and Drug Administration (FDA) issued a recall for an Attune Knee Tibial Articulation Surface instrument, after discovering that the Balseal, or the small wire spring coil used in the range of motion testing to aid in tibial location prior to drilling peg holes, can become damaged and detach.

It lets manufacturers skip much of the FDA’s more strenuous approval process. All rights reserved. Depuy Synthes Joint Reconstruction Introduces Two New Knee Technologies For The ATTUNE® Knee System. (2014, March 12).

(n.d.). Retrieved from, DePuy Synthes. Arthroplasty Today 2016;2:193-­8. The doctor will examine the knee replacement to see that it is healing and working as it should.

The part, called a Balseal, is small.

But hundreds of patients needed revision surgery after their Attune implants loosened.

Learn how to manage pain, swelling, and bruising after a total knee replacement here. Viola Davis, 66 Problem: Meniscal tear within her knee leading to osteo-arthritis.

The “AOX Polyethylene” is a plastic material that is designed to replace cartilage in the knee, which can help improve the device’s strength and resistance to wear.

Background: The ATTUNE Knee by DePuy Synthes was introduced in 2013. FDA Recalls of DePuy Knee Replacement System Depuy has been hit with several recalls of its knee replacement system Friday, April 27, 2018 - The knee is the largest joint in the body and is expected to carry the full weight of an individual with every step. Class 2 Device Recall ATTUNE Articulation Surface. Retrieved from, Johnson & Johnson. A review of area hospitals then found 15 episodes of attune knee failure in the same short period, as well as 21 DePuy replacement cases reported to the FDA medical device database. Results are not guaranteed. Commonly asked questions about ATTUNE Knee System: The ATTUNE Knee System is a device used in knee replacement surgeries that is manufactured by DePuy Synthes, a subsidiary of Johnson & Johnson. That’s what we looked for in compiling this year’s list of best knee replacement blogs — resources that educate, inspire, and empower.

FDA recalls have occurred for some years on many of their knee replacement items, and unfortunately, there were already many of those replacement components that were surgically installed.

Knee Replacement. Fractures (of the device or surrounding bone), Backward or sideways movement in the knee, Instability when standing or putting weight on the Attune knee, Unusual warmth around the knee months after surgery, The Attune knee failed earlier than expected, They experienced tibial loosening with an Attune knee, DePuy Synthes.

If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.

Unfortunately, there have also been many problems associated with knee replacement, and in some cases, those issues could be severe and far-reaching. Consumer Safety Watch offers safety advocate services and attorney referral services for patients throughout the United States including the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin and Wyoming.

Attune lawsuits are still in the early stages. The ATTUNE® Knee was designed to give you a better range of motion and prevent that unstable feeling some experience during everyday activities, such as bending or walking up and down stairs. Several options can provide temporary relief and delay surgery for osteoarthritis (OA) of the knee. For years, Ken Stangl put off having knee replacement surgery, despite the decreasing functionality and increasing pain in his knee. Retrieved from, U.S. Food and Drug Administration. DePuy still uses components developed for the original design. These complications include, but are not limited to: In the case of the ATTUNE System, patients have been experiencing pain on weight bearing, effusion and decreased range of motion within two years of knee replacement surgery. Here, get some tips on lifestyle and medical…. Why was the ATTUNE Knee System Recalled? DePuy Orthopaedics, Inc. Sigma® Knee Portfolio Advances Options With new High Flexion and Total Knee Solutions [Press Release]. (2013, February 22). © 2005-2020 Healthline Media a Red Ventures Company. 1(212): 1­-10. If you or a loved one received a DePuy Synthes Attune knee implant after January 2010, and you have since suffered complications like implant loosening or instability, joint paint, nerve damage, infection or device fracture, you may be entitled to financial compensation for your injuries. 2017; 32:S187-­S192. Calling this number connects you with a Drugwatch representative. Retrieved from, Patil, S.S., Branovacki, G., Martin, M.R., Pulido, P.A., Levy, Y.D. For more information, visit our sponsors page. Retrieved from, U.S. Food and Drug Administration. Retrieved from, DePuy Synthes.(n.d.).

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