Depuy attune total knee arthroplasty rsa study full text. The depuy attune knee was introduced in 2010 and a recent study finds a higher than normal device failure rate. Knee replacement patients are experiencing a surprisingly high number of adverse event reports involving tibial loosening and debonding problems with the. Depuy synthes attune knee the attune knee system, a medical device designed by depuy synthes to improve stability and range of motion in patients undergoing knee replacement surgery, has been linked to complaints from implant recipients of pain and premature device failure resulting in the need for revision surgery, among other serious problems.
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. Attune knee system intuition solo instruments surgical technique depuy synthes companies 1. If you have an attune knee system and are experiencing the symptoms noted above, please give us a call at 800 4726191. Cunningham bounds files lawsuit against depuy due to attune. The intuition instruments combine the surgical process with intuitive and efficient instruments to allow the surgeon to balance the soft tissue and precisely. Depuy attune knee problems linked to unusual number of. 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.
Depuys rotating platform design is intended to reduce stress and wear on the implant. 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. These reports, submitted to the fda, indicate a high number of attune failures caused by loosening or debonding at the cement interface of the tibial baseplate. Thus far, numerous cases of premature failure of the device have been reported to the fdas adverse event reporting system. Mike papantonio discusses the cause of the high failure rate with the depuy attune knee replacement. Depuy designed the attune knee to improve stability and motion. Mike papantonio discusses the cause of the high failure. Depuy attune knee implants failing prematurely daily. This system is a medical device that was designed by depuy synthes to improve range of motion and stability in patients who undergo knee replacement surgery.
Listing a study does not mean it has been evaluated by the u. 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. However, a class ii medical device recall was conducted in 2015 for one component of the system, the attune articulation surface, after it was it was determined that a spring coil could break off and enter the surgical site without the surgeons knowledge. Depuy attune knee replacement lawsuit parker waichman llp. However, since its approval in 2010, many depuy attune knee replacement pateints have reported problems with the device, some of which have resulted in the need for risky revision and reconstructive surgery. Our attorneys will evaluate your potential case free of charge. However, reports now show it can experience early failure or debonding, requiring painful revision surgery years before the typical lifespan. Depuy attune knee recall attune knee lawyer, attorney. Another attune knee problem is the device fails earlier than expected.
Depuy attune knee problems zimmerman reed we never. Patients or those with loved ones who have had a deput attune knee replacement should remain alert for signs and symptoms of tibial loosening. New attune revision knee system from depuy synthes utilizes. It is designed to provide better range of motion and address the unstable feeling some patients experience during everyday activities, such as stair descent and bending. The system encompasses implants designed to work in harmony with your anatomy to deliver stability and motion. Sep 18, 2017 the study, recently published in the journal of knee surgery, explored a number of fda reports to its manufacturer and user facility device experience database related to the attune knee. Cunningham bounds files lawsuit against depuy due to. Oct 10, 2017 the depuy attune knee system is one of the most popular artificial knee replacement systems currently on the market. Depuy attune knee securities attorney gilman law llp. Summary of safety and effectiveness\\oy 3 attune total knee depuy orthopaedlics mgmillion cycles while the sigma mean gravimetric wear rate was 7. Depuy attune knee replacement lawsuit depuy attune knee problems. A recent study published in the june 2017 journal of knee surgery found a high rate of early complications in the attune knee replacement system.
Depuy synthes, based in warsaw, indiana, has announced updated clinical data for its attune knee system. The attune knee implant has been used in more than 400,000 procedures since the fda approved it in 2010, making it one of the most popular systems on the market. To learn more about knee replacement surgery, visit the attune knee system is a new, stateoftheart knee replacement system from depuy synthes joint reconstruction. Prosthesis, knee, patellofemorotibial, semiconstrained, uncemented, porous, coated, polymermetal product code mbh. If that happens, attorneys may ask to combine them in a multidistrict litigation mdl. The attune knee by depuy synthes is an advancement in knee replacement options. The attune knee is a comprehensive, integrated knee system. New attune revision knee system from depuy synthes idata. The problem was that a small wire spring coil on the attune knee tibial articulation surface could become damaged and.
These implants are used in patients who are in need of total knee replacement surgeries, also known as total knee arthroplasty. Some patients have reported complications such as loosening of the device and an increased. Depuy synthes attune knee implants this system is a commonly used implant for people who need knee replacements. The study is titled unusually high rate of early failure of tibial component in attune total knee arthroplasty system at implantcement interface and it was published in june 2017 in the study, surgeons analyzed 15 patients who needed another knee surgery within 2 years of receiving an attune knee replacement because they were suffering from pain, swelling, and limited mobility. Attune knee features address unmet needs for hospitals, patients, and surgeons. Depuy synthes introduces attune revision knee system to.
Extensive research and science is included in the design to help improve functional outcomes for patients, performance for surgeons, and efficiency for providers. Depuy attune knee replacements fail due to adhesion issues. Oct 03, 2014 the attune knee by depuy synthes is an advancement in knee replacement options. The system encompasses implants and surgical instrumentation designed to work in harmony with your anatomy to deliver stability and motion. The study, recently published in the journal of knee surgery, explored a number of fda reports to its manufacturer and user facility device experience. Thus the attune cr fixed bearing total knee system exhibits 50% less overall mean gravimetric wear than the previously cleared depuy.
Depuy is the secondlargest knee implant manufacturer in the world and is responsible for 38% of all knee and him devices recalled between 2003 and 20. The idea is that it can mimic the natural motion of the knee. The lawsuit follows reports of adhesion problems experienced by patients who have been implanted with the attune knee system. Extensive research and science are included in the design to help improve functional outcomes for patients, performance for surgeons, and efficiency for providers. Depuy synthes companies announces new attune revision fixed. Depuy knee overview artificial knees are used to replace either the entire knee joint, or only part of it, in people with extensive damage. Attune knee system 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. Depuy synthes joint reconstruction division of depuy orthopaedics, inc. Unfortunately, there have been reports of nearly 1,500 incidents of mechanical loosening. The attune knee system is designed to address the unmet needs of patients.
The intuition instruments combine the surgical process with intuitive and efficient. The depuy attune knee system is substantially equivalent to currently marketed devices including. Created as a result of more than six years of extensive research to address unmet patient. Depuy also manufactures an attune model for revision knee replacement surgery. The tibial base is designed to address a range of patient needs, from complex primary to partial revision of attune primary knees. Depuy attune knee problems zimmerman reed we never forget. The chart below shows how the attune knee provides more stability while still allowing rotational freedom in deeper flexion. The attune knee system delivers breakthrough discoveries that make the attune knee an advancement for you, your patients, and the hospital you work with. Depuy faces lawsuits resulting from faulty adhesion of knee replacement technology. 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. The attune revision knee system provides the implant options i need to treat a variety of patient anatomies including more metaphyseal sleeve sizes, offset adaptors, stems and fixation choices. Currently, there is not an active depuy attune knee replacement recall.
Thus the attune cr fixed bearing total knee system exhibits 50% less overall mean. Knee replacement patients are experiencing a surprisingly high number of adverse event reports involving tibial loosening and debonding problems with the depuy attune knee system, according to new res. Available with fixed bearing or rotating platform technology, the attune revision knee system is designed to enable surgeons to manage a broad range of complex primary and revision knee procedures. A study by several prominent surgeons published on june 7, 2017 in the journal of knee surgery first highlighted a concerning rate of failures among depuy attune knee implants. About depuy synthes joint reconstruction confidence like. Depuys attune knee replacement is suffering unusually high rates of early failure due to loosening and poor bonding of metal to bone, according to a study published in the journal of knee surgery. Learn more about our national knee replacement representation here. The attune knee system results detailed below demonstrate how the attune. The depuy synthes attune total knee arthroplasty tka system has been the subject of hundreds of complaints to the fda about the knee devices problems. The attune cementless knee has the same great kinematic features of the cemented attune knee, but i feel the cementless technology is a better alternative for my younger and more active patients who have healthy, strong bones, said ryan m. Depuy attune knee replacement patients report tibial loosening. Depuy attune knee lawsuit early implant failure side effects. Depuy attune knee failures focus of talking points for sales.
The intuition instruments are designed to be used with the singleuse pin pack 254400111 that contains universal pins and threaded headed pins. Knee addresses challenges in total knee arthroplasty tka such as crepitus. When the knee joint becomes so damaged, from arthritis, or other conditions, replacement with artificial components can restore mobility and reduce pain. Instead, the attune knee has been linked to severe complications. Depuy synthes attune knee replacement legal help if you or a loved one has suffered similar damages or injuries, please fill in our form and your complaint will be sent to a lawyer who may. Depuy attune knee failures focus of talking points for. 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. The tibial base plate design of the attune knee system can lead to failure of the adhesive holding the implant to the tibia bone. Bhushan nariani attune knee replacement surgeon in delhi.
At parker waichman llp, our attorneys have been investigating claims regarding defective depuy attune knee replacement systems. According to the company, a multicenter study of 200 cases presented at the 2nd world arthroplasty congress in rome on patient reported outcome measures proms reported a statistically significant improvement in knee physical function at six months with the attune knee compared to. Depuy synthes, a subsidiary of johnson and johnson, is the manufacturer of attune knee implants. The availability of an extensive range of implant sizes for asian patients enables your surgeon to find the. A curved portion of the implant is supposed to keep movement smooth and provide stability, and the articulating component is closest to a kneecap. The problem was that a small wire spring coil on the attune knee tibial articulation surface could become damaged and come off. The depuy attune knee system is one of the most popular artificial knee replacement systems currently on the market. The surgeons performed revision surgery on 15 people who had pain. Depuy touts benefits of attune knee despite high failure rates.
Jnj subsidiary depuy synthes attune total knee arthroplasty system is experiencing an unusually high rate of early failure related to its tibial components, according to a new study. Doctors noted more and more patients were experiencing detachment of their implants from lower leg bones. The depuy attune knee system is a total knee replacement implant. If you or someone you love has had a depuy attune knee replacement, call alexander shunnarah personal injury attorneys today at 18002297989. The tibial articulation surface trial snaps together with the shim component to function as the insert trial during a total knee replacement. The early clinical results of the attune knee are promising and include data from national registries, company initiated, independent studies, and investigator. The depuy knee replacement lawyer dean goetz is currently investigating cases where patients were implanted with the depuy synthes attune knee system a total knee replacement solution. High numbers of complaints have recently emerged from patients who have been implanted with the depuy synthes attune knee system. Oct 11, 2017 currently, there is not an active depuy attune knee replacement recall. A total knee replacement is one of the most commonly performed and successful operations available, with 8590% of patients achieving significant improvements in pain. A 2017 study published in the journal of knee surgery indicated that loosening incidents with the depuy attune knee replacement system may be underreported. The depuy attune knee replacement is billed as a system that works with the bodys muscles, bones, tendons and ligaments. Depuy attune total knee arthroplasty rsa study the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The implant was approved by the fda in 2010 and orthopedic surgeons have been using it widely for the last five years.
Attune knee system surgical technique depuy synthes companies 5 pinning the attune knee system has 3. Mar 15, 2017 depuy synthes companies developed the attune knee system to improve the stability and motion of knee replacement, which are important to patient satisfaction. Value analysis brief attune knee system depuy synthes 1. A recent study published in the journal of knee surgery warned about an unusually high rate of early failure of tibial components due to poor bonding between the patients bones and the attune knee implant. To date march 20, more than 3,500 patients have received an attune knee as part of a. New report demonstrates the clinical and economic value of. The report concludes that in a valuebased healthcare environment with cost.
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