Polyethylene spinout in the attune cruciateretaining. Knee arthroplasty solutions featuring the attune total knee. The attune revision knee system introduces a new chapter in the attune knee story, said rajit kamal, vice president and global platform leader, knees, depuy synthes. The attune knee is different from other knee systems. The attune primary total knee replacement system value. The design is fine tuned to help improve how the knee replacement feels and moves. Kathy boggs senior regulatory affairs specialist 700. Attune knee system family of implants with the depuy synthes companies cas computer assisted surgery system, software version 2. Notice is being issued due to the potential for the balseal. However, within only five years after the knee was. Value of the attune knee system in todays valuebased environment.
The performance of the attune knee is in line with other knee systems. About depuy synthes references joint reconstruction. Panel for their dedication to the development of the triathlon knee system. Attune%20hospital%20presentation%20dsus%20jrc%200814% 200373. Attune gradius curve, the gradually reducing femoral radius, is designed to provide stability throughout the entire range of motion. William barrett, md chair david dalury, md nader nassif, md kirk reichard, md russell windsor, md charlie yang, md jana flener, pac. The depuy attune knee system is a complete, artificial knee joint, and it has been in the news a lot lately because of lawsuits being filed over failures in the system after surgery. In an irb approved early outcomes study, physiotherapists collected data on 40 patients implanted with attune knees and 40 patients with sigma cr150. The surgery involves up to five days in the hospital and up to a year of recovery. Depuy also manufactures an attune model for revision knee. Attune revision fixed bearing knee instrumentation and demonstrates the convenience of use in a surgical setting.
The availability of an extensive range of implant sizes for asian patients enables your surgeon to find the. With six years of successful clinical history and more than 575,000 attune primary knees implanted worldwide, the new attune revision knee system allows us to bring. The attune knee system is a new, stateoftheart knee replacement system from depuy. Each of these significant technologies was designed to provide function for surgeons in the operating room and for patients after surgery. As part of the depuy attune knee system, the depuy attune ps femoral components and tibial inserts are intended for cemented use as a total knee replacement system. The broader distal radius articulating against a relatively congruent tibial insert provides increased constraint and reduced contact stress in the range of flexion used for. In march 20, defendants introduced its attune system, including procedures for implantation, to surgeons and consumers. This means the replacement may be expected to provide improved wear performance. Food and drug administration fda the attune system was introduced to the market in 2011. The intuition instruments are designed to be used with the singleuse pin pack 254400111 that contains universal pins.
Aug 16, 2019 knee arthroplasty solutions featuring the attune total knee system agenda 6. Attune knee system surgical technique depuy synthes companies 5 pinning the attune knee system has 3. The depuy attune knee system is a total knee replacement implant. Several new patented technologies offered by the attune knee are designed to maximize the range of knee movement when bending the knee, while maintaining stability during activities. Attune knee system overview the attune knee system is designed to deliver a high level of stability and motion. Jan 12, 2015 the attune ps total knee is intended to accommodate knee flexion to 145 degrees in those patients able to attain a high degree of knee flexion. Extensive research and science is included in the design to help improve functional outcomes for patients, performance for. Depuy attune knee replacement lawsuit filed over premature.
Introduction the triathlon knee system instrumentation has been developed based on strykers 30year orthopaedic history. Attune knee system cruciate sacrificing, rotating platform, balanced resection surgery with peter james, md 104662181227 attune csrpbalancedresectionsurgeryjames 0 view. The depuy attune knee system is substantially equivalent to currently marketed devices including. Developed as a result of more than six years of extensive research, the attune knee system has been designed to allow a greater degree of stability and mot. Extensive research and science is included in the design to help improve functional outcomes for patients, performance for surgeons, and efficiency for.
The depuy attune knee system is intended for cemented use as a total knee replacement system. Candidates for total knee replacement include patients with a severely painful. The system combines the expertise of orthopaedic and human factors engineers with that of surgeons and or staff worldwide. The attune knee is a comprehensive, integrated knee system. Knee addresses challenges in total knee arthroplasty tka such as crepitus. The attune knee system has specifically designed pins to increase the stability and functionality of the instruments.
The depuy attune knee system is a stateoftheart, highly technological knee replacement system that has come under fire in recent year for having significant defects. Pdf a comparison of clinical and patientreported outcomes of the. The attune knee system depuy synthes, warsaw was designed in an effort to improve patient outcomes by providing more options for bearing and allowing easier kinematic balancing, as well as having a more anatomic patella and trochlear groove 6,11,12. The early clinical results of the attune knee are promising and include data from national registries, company initiated, independent studies, and investigator. National bioskills laboratories 435 forbes blvd south san francisco, ca 94080.
Depuy attune knee replacement lawsuits my vaccine lawyer. The attune knee system has been used since 2011 and became widely available in 20. Through several key patented technologies, the attune knee system can help patients achieve the best possible range of motion while giving them the confidence of a stable knee replacement. The 510k fda approval process allows manufacturers to skip doing clinical trials on a product because it is so close to a product already on the market.
Attune gradius curve tm the patented sagittal geometry of the attune femoral components is a result of extensive research on the motion observed with traditional knee designs. Studies of total knee patients revealed that patients are not always satisfied with their outcome and report differing levels of satisfaction following surgery. Clinical evidence evidence attune knee system total. May 16, 2011 the attune ps total knee is intended to accommodate knee flexion to 145 degrees in those patients able to attain a high degree of knee flexion. The depuy attune knee system was fasttracked by the fda as depuy represented to the fda that the attune knee system was substantially similar to devices on the market. The attune knee system can help patients return to their normal activities sooner than anticipated 23, while also enabling surgeons and health systems to improve clinical outcomes. Depuy synthes companies has applied for extensive patent protection in countries throughout the world for the attune system implants, instruments, and surgical methods. This new tka system features a gradually reducing femoral radius, an innovative scurve design of the posteriorly stabilized cam, tibial base which can be downsized or upsized two sizes versus the insert, novel patella tracking, lighter innovative instruments, and a. Available with fixed bearing or rotating platform technology, the attune revision knee. Attune knee system cruciate sacrificing, rotating platform. The depuy attune total knee system is intended for cemented use as a total knee replacement system.
Pma monthly approvals from 612018 to 6302018 original. Unusually high rate of early failure of tibial component. Dec 02, 2010 the attue cr knee system is intended to accommodate knee flexion to 150 degrees in those patients able to attain a high degree of knee flexion. Attune knee system surgical technique depuy synthes joint reconstruction 7 pinning the attune knee system has specifically designed pins to increase the stability and functionality of the instruments. New report demonstrates the clinical and economic value of the.
This content is intended for health care professionals in the united states. Depuy synthes joint reconstruction has experience in producing world leading knee systems. The attune revision knee system is a comprehensive revision system that integrates the stability in motion that is a hallmark of the primary attune knee system with proprietary design features to address key challenges in revision knee arthroplasty. Confi dent implant positioning is the combination of multiple. Approval for adding the attune cemented tibial bases, rotating platform rp as an extension to the attune knee system. Available with fixed bearing or rotating platform technology, the attune revision knee system is designed to enable surgeons to manage a. The attune cementless cr and ps femoral components are intended for cementless use as the femoral components of the attune knee system. The attune knee system delivers breakthrough discoveries that make the attune knee an advancement for hospitals, patients, and surgeons. The attune cementless knee utilizes patented technologies of the attune knee system and rotating platform option, with the added benefit of biologic fixation with porocoat porous. P830055s198 06272018 r realtime proc lcs total knee system depuy, inc. The attune knee system is designed to address implant fit femoral component overhang of 3 mm is associated with an almost twofold increased risk of knee pain more severe than occasional or mild at 2 years after surgery. The attune knee system is backed by a comprehensive evidence generation program that encompasses clinical and patient reported outcomes proms as well as value based healthcare studies. This surgical technique goes through a femur first hybrid workflow, however the attune knee system will allow all available workflow.
Sigma cocr tibial trays reason for 510k submission addition of a new cemented tibial base component to the attune knee system device description the attune cemented tibial base, fixed bearing fb are available in sizes 110. Depuy synthes companies developed the attune knee system to improve the stability and motion of knee replacement, which are important to patient satisfaction. There have been multiple reports of failures sent to the fda as well as studies that have shown the knee fails early and in most cases of failure comes loose. The attune knee system overview brochure is designed to provide an overview of the system. A surgical technique guide is also available, which provides detailed guidelines for the preparation and implantation of the attune revision fixed bearing knee system through a variety of workflows.
Cahndidates for total knee replacement include patients with a severely. The attune primary total knee system is designed with the goal of addressing the clinical needs of patients, surgeons, and hospital providers around the world. Fdaapproved in 2011, attune knee devices should last for at least twelve years. An early outcome study of the attune knee system vs. Addition of new porous fixed bearing tibial bases and patellae devices to the attune knee system.
Small and consistent 3 mm ap increments between sizes minimizes the effect on the fl exion gap in the case of up or down sizing. Value analysis brief attune knee system depuy synthes 1. The attune knee system implant is designed to work in harmony with knee muscles and ligaments, maximize the range of knee movement and provide high flexion while conserving your natural anatomy. The manufacturer of the attune knee system allows surgeons to sacrifice both the anterior cruciate ligament acl and the posterior cruciate ligament pcl with the attune cruciateretaining rotatingplatform cr rp configuration as it is based around the model of lcs. Additional information evidence attune knee system. The intuition instruments are designed to be used with the singleuse pin pack 254400111 that contains universal pins and threaded headed pins. New attune revision knee system from depuy synthes idata.
Depuy attune revision knee system, k160700 depuy attune total knee system, k2047. While total knee replacement surgery can be a highly successful procedure, in some. Traditional knee replacement designs utilize multiple discrete radii to define the sagittal plane curvature of the femoral component fig. However, the depuy synthes attune knee replacement system has been found to have an unusually high rate of failure, as reported by surgeons to the federal food and drug administration fda, due to debonding loosening of the cement interface it requires. About depuy synthes joint reconstruction confidence like. More importantly, if implanted earlier, it may restore patients to their active lifestyles sooner.
The resulting attune system purported to feature a gradually reducing femoral radius, an. According to defendants, the new attune system was an attempt to improve functional outcomes, provide more stability and simplify implantation of the contemporary total knee system. Tibial articulation surface instruments used in trialing with the attune knee system. Knee arthroplasty solutions featuring the attune total knee system agenda 6. Jan 26, 2016 the attune knee system is designed to help patients get back to what they enjoy sooner by optimizing how a patients knee replacement feels and moves. Attune intuition tibial articulation surface instruments. This geometry was derived to replicate the function of the natural knee joint. Pam, a real attune knee replacement patient, got back to her career. Patient need view graph the attune knee started with a patient need. Dibala indicates that she received a depuy attune knee system during a left total knee arthroplasty in april 20. The attune knee system offers 10 standard and 4 narrow femoral sizes. Depuy synthes introduces attune revision knee system to. Short term patient outcomes after total knee arthroplasty.
The attune knee system results detailed below demonstrate how the attune. Oct 05, 2018 more than 600,000 total knee replacements tkrs are performed each year in the united states,1 with projected growth by 85%, to 1. Depuy synthes companies announces new attune revision fixed. Depuy attune knee replacements tibial loosening drugwatch. Attune knee system surgical technique depuy synthes companies 3. However, depuy claimed back in 2010 that attune knee was substantially equivalent to the zimmer biomet nexgen cr knee system. Additional data, in particular for research purpose, can found in.
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