Cunningham bounds files lawsuit against depuy due to. But patients have filed hundreds of reports claiming that the devices loosened. 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 fda also noted that medical device correction was being advised for all depuy attune knee replacement models, which sums up to 3,474 units. Rearrange individual pages or entire files in the desired order. The attune knee system overview brochure is designed to provide an overview of the system. Since 2011, more than 700,000 total knee replacement surgeries have used depuy s attune knee implant worldwide. Depuy attune knee replacement lawsuit parker waichman llp. Depuy synthes manufactured the attune knee implant with the goal of improving outcomes following total knee replacement surgery. 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. Oct 06, 2017 the complaint pdf was filed by rocky thompson in the u. Depuy engineered its attune knee replacement to be one of the most advanced on the market. The attune knee system is designed to deliver a high level of stability and motion. Patients treated with this device may be able to sue depuy synthes for negligence and recover compensatory as well as punitive damages.
Depuy knees have been found to fail in just 12 years following implantation. In june of 2015, depuy synthes was forced to issue a worldwide voluntary recall of several of the component parts of its attune. 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. Depuy further states that the attune offers the added benefits of shorter hospital stays and quicker recovery times. The depuy attune knee system is substantially equivalent to. About depuy synthes joint reconstruction confidence like. Thermo fisher scientific certifies that the attune nxt flow cytometer conforms to relevant directives to bear the ce mark. Instead of failing after 12 years or more, many fail after 2 years. If your depuy knee failed and required revision surgery long before 15 years, you may be eligible to file a depuy knee claim. Early results confirm clinical and economic value of the. For persons and family members of persons who meet these qualifications, it is likely you will be eligible to file a depuy. If you or a member of your family have suffered from the early failure of a defective depuy knee, experiencing symptoms such as pain, instability, bone damage and the need for revision, you may have grounds to file a depuy. Depuy synthes companies has applied for extensive patent protection in countries throughout the world for the attune system implants, instruments, and surgical methods. Disengage the distal femoral jig from the handle by pushing on the vv indicator cap and slide the jig toward the femur until the distal plate contacts the distal femur.
Despite the overall high success rate in knee replacement surgeries, researchers have identified largerthanusual failure rates with the depuy synthes attune knee system. Each aspect of knee replacement design and the surgical process was evaluated. The depuy attune tka device seems to be particularly susceptible to premature tibial loosening. 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.
Zimmer biomet has faced more than 1,700 lawsuits over its nexgen implant. The attune knee by depuy synthes was introduced in 20. Depuys attune knee replacement system failures leads to. This content is intended for health care professionals in the united states. The lawsuit was filed in federal court in hawaii on july 1. The attune knee system, the largest research and development project in the history of depuy synthes joint reconstruction, was designed to provide better range of motion and address the unstable feeling some patients experience during everyday activities such as stair descent and bending. Knee system is the result of the largestever research and development program from. 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. A 2017 study published in the journal of knee surgery indicated that loosening incidents with the depuy attune knee replacement system may be underreported. As was the case with medical device lawsuits in the past for products like stryker hip, zimmer knee and depuy. Depuy attune knee replacement lawsuit filed over tibial. Jnj subsidiary depuy synthes attune total knee arthroplasty system is experiencing an unusually high rate of early failure related to its tibial components.
Cunningham bounds files lawsuit against depuy due to attune. Fluorophore selection guide for the attune nxt acoustic. Oct 11, 2017 currently, there is not an active depuy attune knee replacement recall. Lawsuits for defective depuy knee replacement systems. The system encompasses implants and surgical instrumentation designed to work in harmony with your anatomy to deliver stability and motion. Pg94pj6317co296reagentselectionguidefor attune dd created date. In this example, forward scatter fsc is displayed on the xaxis and side scatter ssc on the. The instrument also conforms to the ul and cancsa general requirements 61010.
Novel testing protocols and methods were used during development. About the attune knee depuy synthes joint reconstruction is a leader in knee replacement with nearly 40 years of experience in developing innovative knee replacements for patients. Depuy synthes introduces attune revision knee system to. Depuy attune knee replacement system recall and complications.
The attune knee is a comprehensive, integrated knee system. Depuy synthes adds to its attune line of knee products. The attune knee is one of the largest research and development projects in the history of depuy synthes joint reconstruction and. In the case of depuy s attune system, the reported early failures are often caused by tibial loosening at the implantcement interface. Australian orthopaedic association national joint replacement registry aoanjrr, automated industry report system airs, id no. District court for the middle district of louisiana on september 26, alleging that the widely used depuy attune knee is defectively. Over 250,000 doctors use vumedi to improve patient care and grow their practice. The complaint pdf was filed by rocky thompson in the u. Problems with attune include loosening of the tibial component at the implantcement interface within the first two years after implant. Attune knee system linked to improvements in patient. Depuy synthes has documented dozens of premature failures of their attune knee system resulting in destabilization of knee replacements and subsequent painful revision surgeries. Lawyers expect thousands of claims for attune debonding will likely be filed as more patients find out the cause of their knee implant problems.
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. However, a class ii medical device recall was conducted in 2015 for one component of the system, the attune articulation. 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 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. The latest depuy attune knee replacement lawsuit is reportedly coming out of mobile, alabama. Thus far, numerous cases of premature failure of the device have been reported to the fdas adverse event reporting system. Manufacturer narrative this complaint is still under investigation. At least one study found an unusually high failure rate for attune. At parker waichman llp, our attorneys have been investigating claims regarding defective depuy attune knee replacement systems. The ps attune knee airs report indicates that there is a 27% lower likelihood of revision at four years followup, compared to all other total knee hr0. As was the case with medical device lawsuits in the past for products like stryker hip, zimmer knee and depuy hip implants, these claims will end up in specialized multidistrict.
Synthes ireland is an entity doing business and organized in ireland with its principal place of business located at unit 2. Attune knee system linked to improvements in patient quality of life and reduced length of hospital stay recent evidence shows potential positive impact of implant design on functional outcomes and hospital discharge status warsaw, indiana, may 10, 2018. 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 record is updated if the fda identifies a violation and classifies the action as a recall, and it is updated for a final. Sanchez, says the defective depuy sigma implant forced him to endure numerous medical procedures, including surgery to remove and replace the implant. The attune knee, the latest innovation in knee replacement from depuy synthes joint reconstruction, is the result of more than six years of research and. The attune system is only available with depuy synthes. Attune nxt flow cytometer thermo fisher scientific.
Knee replacement loosening, failure results in lawsuit. Depuy synthes offers attune in a number of sizes to allow the implant to be used in a wide variety of patients. Knee replacement lawsuits settlements and verdicts. Attune knee system overview the attune knee system is designed to deliver a high level of stability and motion. Mar 08, 2018 depuy attune knee system failures knee replacement patients report depuy attune implant loosening and failure knee replacement surgery, also known as arthroplasty, is a common orthopedic procedure used to relieve pain in patients whose knees have been damaged by debilitating arthritis, severe injury, or excessive wear and tear. Depuy attune knee system failures mcgartland law firm. Depuy attune knee implant complications neblett, beard. A comparison of clinical and patientreported outcomes of the cemented attune and pfc sigma fixed bearing cruciate sacrificing knee systems in patients who underwent total knee replacement with.
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. It will automatically populate the dropdown list and copy to the. But, as our attune knee replacement attorneys ask, if the original attune knee was considered to be troublefree and safe, why the redesign. According to the complaint pdf, sanchez suffered from endstage arthritis in his left knee. 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. Attune knee system surgical technique depuy synthes companies 11 distal femoral resection insert the im rod into the femoral canal to the level of the isthmus. Knee replacement lawsuits frequently claim the devices loosened or became so unstable they had to be replaced. 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. The victim underwent knee replacement surgery in 2015 and like many victims of the defect, started. Depuy synthes companies announces new attune revision fixed. A comparison of clinicaland patientreported outcomes of the.
Firm files lawsuit against depuy due to knee replacement. Depuy synthes companies has applied for extensive patent protection in countries throughout the world for the attune system. First depuy knee lawsuit filed in wake of recent warnings. Depuy attune knee implant lawsuit depuy attune knee implant lawsuit depuy s attune total knee arthroplasty system tka has been linked to a high risk of premature failure, causing some patients. The attune knee system is a new, stateoftheart knee replacement system from depuy synthes joint reconstruction. In a clinical study, patients required significantly less time to meet the necessary criteria to leave the hospital 2,3. Updated clinical data for depuys attune knee orthopedics. Value analysis brief attune knee system depuy synthes 1. Sep 20, 2017 as reports of failures with depuy synthes attune knee replacement grow, there is increasing evidence the device is defective and harming patients many, if not the majority, reports of failure in the synthes attune knee have been reported as tibial baseplate failure or debonding. 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. The attune primary total knee replacement system value.
Downloading and importing bead lot files for attune. This system is a medical device that was designed by depuy synthes to. The complaint pdf was filed by robert long in the u. A guide to analyze attune nxt fcs data files in fcs. If you recently underwent an unsuccessful knee replacement surgery using the attune knee system, reach out to our louisville defective medical device lawyers for help. Instead, the attune knee has been linked to severe complications. 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. On your attune acoustic focusing cytometer computer, save the bead lot file to any location.
Louisville depuy recall lawyer depuy knee implant recall. Depuy attune knee lawsuit early implant failure side effects. Oct 10, 2017 the depuy attune knee system is one of the most popular artificial knee replacement systems currently on the market. Development process the attune knee system represents one of the largest research and development projects in the history of depuy synthes joint.
New attune revision knee system from depuy synthes utilizes. District court for the eastern district of kentucky on february 1, alleging that failure of a depuy attune knee has left him with severe. Depuy synthes attune knee replacement failures grow. Food and drug administration had issued a recall of the original component of the depuy attune knee system. About depuy synthes references joint reconstruction.
Attune knee implants have an abnormally high failure rate. Attune knee system implants are available in one configuration which allows for cruciate retaining cr or cruciate sacrificing cs applications and another configuration which allows for posterior stabilized ps applications. Oct 03, 2014 the attune knee by depuy synthes is an advancement in knee replacement options. Depuy attune knee failures focus of talking points for sales. Depuy will notify the fda of the results of this investigation once it has been completed. Depuy synthes, based in warsaw, indiana, has announced updated clinical data for its attune knee system. However, in recent months, depuy has filed dozens of reports with the food and drug administration documenting premature failures of the attune knee replacement system that have resulted in the destabilization of patients knee replacements and painful revision surgeries. And lawyers report new cases claiming injuries from the depuy synthes attune. The file save export dialog box uses the standard microsoft windows browser, which opens to the lastvisited directory where files were saved, and allows you to locate and select files for exporting. In an irb approved early outcomes study, physiotherapists collected data on 40 patients implanted with attune. At least one study found an unusually high failure rate for attune knee implants. 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.