Depuy synthes companies announces new attune revision fixed. To change the order of your pdfs, drag and drop the files as you want. Depuy synthes adds to its attune line of knee products. Cunningham bounds files lawsuit against depuy due to. The attune knee system is designed to deliver a high level of stability and motion.
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. Depuy also manufactures an attune model for revision knee replacement surgery. In a clinical study, patients required significantly less time to meet the necessary criteria to leave the hospital 2,3. Due to the similarity of these cases and the numerous ones that have been filed since, lawyers will ask that they be consolidated to a depuy attune knee class action or multidistrict litigation lawsuit. Attune nxt flow cytometer thermo fisher scientific. Updated clinical data for depuys attune knee orthopedics. The attune revision fixed bearing tibial base and cemented stem were developed to address more complex clinical needs and expand treatment options for patients.
Knee replacement products depuy synthes is offering one of the most comprehensive knee portfolios survivorship of the sigma hp partial knee compares favourably within the class of uka6 sigma is one of the most clinically proven total knee replacement systems and is supported by 96 journal articles and 5 national joint registry reports on 251,292 sigma knees7. Depuy attune knee replacement lawsuit filed over tibial. The attune system is only available with depuy synthes. But, as our attune knee replacement attorneys ask, if the original attune knee was considered to be troublefree and safe, why the redesign. Australian orthopaedic association national joint replacement registry aoanjrr, automated industry report system airs, id no. The journal of knee surgery published research showing that the attune knee implant system had a high rate of premature failure and loosening of the tibial component. Depuy synthes companies personnel will often travel with the mission volunteers to support their work as well. Looking at the numbers for the first half of 20, it appears that the depuy synthes merger may have been more difficult for its spine business than originally expected. Lawsuits for defective depuy knee replacement systems. Oct 03, 2014 the attune knee by depuy synthes is an advancement in knee replacement options. According to the fdas manufacturer and user facility device experience maude database, more than 1,400 patients have experienced failure problems with their depuy attune knee replacement. The attune knee system overview brochure is designed to provide.
Founded in 1895, depuy synthes joint reconstruction was the first commercial orthopaedics company in the united states. 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. Currently, there is not an active depuy attune knee replacement recall. A comparison of clinicaland patientreported outcomes of the. Available with fixed bearing or rotating platform technology, the attune revision knee system is designed to enable surgeons to manage a broad. Depuy attune knee replacement lawsuit depuy attune knee problems. Since 2006, our depuy synthes companies international organization has supported open arms malawi, providing housing, food and funds to the children of malawi impacted and orphaned by hivaids. The attune knee is a comprehensive, integrated knee system. The early clinical results of the attune knee are promising and include data from national registries, company initiated, independent studies, and investigator. 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.
Oct 06, 2017 the complaint pdf was filed by rocky thompson in the u. Numerous cases of premature failure of the depuy synthes attune knee system have been reported to the fdas adverse event reporting system. Depuy attune knee replacements tibial loosening drugwatch. An early outcome study of the attune knee system vs. 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. 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.
Depuy synthes, based in warsaw, indiana, has announced updated clinical data for its attune knee system. The record is updated if the fda identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Lawsuit over alleged debonding hits depuy s attune knee walter eisner tue, february 27th, 2018 print this article. The depuy attune knee system is a total knee replacement implant. Mar 15, 2017 according to rajit kamal, global knee platform leader, depuy synthes joint reconstruction, depuy synthes worked with renowned experts around the world to develop the attune knee system. Louisville depuy recall lawyer depuy knee implant recall. This procedure, which has been used in the past for defective or recalled medical devices. Science and technology, general implants, artificial prostheses and implants prosthesis. The tibial base is designed to address a range of patient needs, from complex primary to partial revision of attune primary knees.
For patients undergoing knee replacement surgery, a knee implant that allows them to enjoy improved stability and range of motion, and helps them return to their normal activities is important. Orthopedic surgeons and patients alike have complained of the unusually high premature failure rate of the implant. Depuy attune knee replacement patients report tibial loosening. Attune knee system overview the attune knee system is designed to deliver a high level of stability and motion.
The complaint pdf was filed by robert long in the u. Lawsuit over alleged debonding hits depuy s attune knee walter eisner tue, february 27th, 2018. District court for the eastern district of kentucky on february 1, alleging that failure of a depuy attune knee has left him with severe. Jnj subsidiary depuy synthes attune total knee arthroplasty system is experiencing an unusually high rate of early failure related to its tibial components.
The latest depuy attune knee replacement lawsuit is reportedly coming out of mobile, alabama. 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. New report demonstrates the clinical and economic value of. Lawsuit over alleged debonding hits depuys attune knee.
District court for the middle district of louisiana on september 26, alleging that the widely used depuy attune knee is defectively. Oct 11, 2017 currently, there is not an active depuy attune knee replacement recall. Depuy attune knee implants failing prematurely daily. Development process the attune knee system represents one of the largest research and development projects in the history of depuy synthes joint. The attune knee system was introduced by depuy synthes as a result of the largest research and development project in the companys history, and was.
Early results confirm clinical and economic value of the. A 2017 study published in the journal of knee surgery indicated that loosening incidents with the depuy attune knee replacement system may be underreported. A national personal injury law firm attune knee implant raised concerns dislodged components behind depuy attune knee system recall defective medical device attorneys helping clients with their depuy attune knee replacement lawsuit patients report severe complications from a component of the depuy synthes attune knee implant. Depuy synthes introduces attune revision knee system to. Oct 10, 2017 the depuy attune knee system is one of the most popular artificial knee replacement systems currently on the market. Newest depuy attune lawsuit out of mobile, alabama.
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 designed the attune knee to improve stability and motion. Depuy attune knee failures focus of talking points for sales. Depuy synthes launches attune revision knee orthopedics. Many of the failures are speculated to be related to the loosening of the tibial baseplate in the artificial knee. The invitrogen attune nxt flow cytometer combines precision with performance in a true benchtop flow cytometer with up to 4 lasers and 16 parameters of detection. The attune knee is one of the largest research and development projects in the history of depuy synthes joint reconstruction and combines the latest in design, kinematics, engineering and materials to deliver stability and motion. When the knee joint becomes so damaged, from arthritis, or other conditions, replacement with artificial components can restore mobility and reduce pain. Depuy knee overview artificial knees are used to replace either the entire knee joint, or only part of it, in people with extensive damage.
Depuy engineered its attune knee replacement to be one of the most advanced on the market. Cunningham bounds files lawsuit against depuy due to attune knee replacement failure. The attune knee is one of the largest research and development projects in the history of depuy synthes joint reconstruction and combines the latest in. Jnj subsidiary depuy synthes today touted 4year data from a large registry study showing that its attune knee implant had a lower revision rate than the overall rate for. Knee replacement loosening, failure results in lawsuit. Depuys rotating platform design is intended to reduce stress and wear on the implant.
At least one study found an unusually high failure rate for attune knee implants. Unusually high rate of early failure of tibial component. Patients or those with loved ones who have had a deput attune knee replacement should remain alert for signs and symptoms of tibial loosening. 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. Llc filed what is believed to be the first lawsuit in the country involving a premature failure of the. The first lawsuit over depuy synthes attune knee system was filed in alabama in september 2017. More lawsuits have followed, claiming cement that connected the implants to patients bones failed. Jan 15, 2018 the depuy synthes attune knee replacement device is one of the devices facing scrutiny in the healthcare community as patients are reporting device failure, often within months of the surgery. The attune knee by depuy synthes was introduced in 20.
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. If information is obtained that was not available for the initial medwatch, a. 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. New attune revision knee system from depuy synthes utilizes. The attune nxt flow cytometer was developed with the goal of removing barriers associated with flow cytometry and enabling new research. Unusually high rate of early failure of tibial component in. If youre considering knee replacement surgery, the attune knee system is a stateoftheart knee replacement system that can help you on the path to a faster recovery. Intuition instruments for depuy attune knee system mdea 2014 silver winner duration. Depuy synthes is a global leader in orthopaedic trauma devices for internal and external fixation.
Craniomaxillofacial cmf depuy synthes cmf offers a comprehensive portfolio of products to treat. Attune nxt acoustic focusing cytometer the invitrogen attune nxt acoustic focusing cytometer is a benchtop cytometer that uses acoustic pressure to confine the injected particles to a tight central line as the sample passes through the optical cell for interrogation. Over 250,000 doctors use vumedi to improve patient care and grow their practice. We have maintained the attune gradius curve to provide stability through the range of motion 1,2,3 and glideright articulation for improved patellafemoral kinematics. If that happens, attorneys may ask to combine them in a multidistrict litigation. Depuy attune cr and attune ps comprising primary knees implanted up to. 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. The knee system used in this study was the attune knee system depuy synthes. Depuy synthes is a franchise of orthopaedic and neurosurgery companies. Under this licence, depuy is free to distribute this document, subject to the restrictions specified in the national joint registry supplier feedback data access and.
If information is obtained that was not available for the initial medwatch, a followup medwatch will be filed as appropriate. The attune primary total knee replacement system value. To merge pdfs or just to add a page to a pdf you usually have to buy expensive software. Depuy synthes companies has applied for extensive patent protection in countries throughout the world for the attune system implants, instruments, and surgical methods. Depuy will notify the fda of the results of this investigation once it has been completed. Current clients report early failure of the device, sometimes within just months of their surgery. Depuy attune total knee arthroplasty rsa study the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Our servers in the cloud will handle the pdf creation for you once you have combined your files. To learn more about knee replacement surgery, visit the attune knee system is a new, stateoftheart knee replacement system from depuy. Value analysis brief attune knee system depuy synthes 1. The food and drug administration fda has received extensive reports regarding the failure of depuy attune knee replacements. The attune cementless knee system includes the patented technologies of the attune knee system.
Depuy attune total knee arthroplasty rsa study full text. Kittie, a retired teacher and principal, is very passionate about cycling. The attune intuition instrumentation is unique in its ability to combine the surgical. Delivering a comprehensive range of power instrument systems, reamers and saws to meet a broad spectrum of clinical needs. Depuy synthes adds cementless option for attune knee elizabeth hofheinz, m. Please, select more pdf files by clicking again on select pdf files. Attune revision fixed bearing knee instrumentation and demonstrates the convenience of use in a surgical setting. 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. In the case of the attune knee, this is due to a questionable design whereby the surface of the implant is smoother than normal, making adherence difficult. Listing a study does not mean it has been evaluated by the u.
Knee replacement lawsuits settlements and verdicts. Cunningham bounds files lawsuit against depuy due to attune. 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. The depuy attune knee was introduced in 2010 and a recent study finds a higher than normal device failure rate. About depuy synthes joint reconstruction confidence like. But patients have filed hundreds of reports claiming that the devices loosened. Since its release almost a decade ago, it has been used in more than 400,000 knee replacement procedures. Depuy attune knee failures focus of talking points for. Manufacturer narrative this complaint is still under investigation. The victim underwent knee replacement surgery in 2015 and like many victims of the defect, started experiencing swelling, instability, decreased motion, and persistent pain.
435 251 979 1150 479 931 328 1144 195 1462 417 457 394 1318 1222 1457 1226 1325 1420 186 1450 127 1416 792 1073 1454 1352 1409 175 820 1421 976 702 1044 1568 793 475 342 80 1318 601 513 842 607 64 88