From this site you can view or print instructions for use for depuy synthes devices. The attune system is only available with depuy synthes. Since its release almost a decade ago, it has been used in more than 400,000 knee replacement procedures. Glassman a recent study conducted by nine prominent orthopaedic surgeons and published in the journal of knee surgery revealed the attune total knee arthroplasty system had an unusually high rate of failure, prompting calls for further research. This surgical technique is based on the brainlab knee3 software. Attune knee system surgical technique depuy synthes joint reconstruction 9 distal femoral resection with the knee in flexion, remove osteophytes from the intercondylar notch. Attune knee system surgical insights for the rotating platform feat. Introduction total knee replacement surgery can be a highly successful procedure. Limbsparing techniques, using modular segmental endoprostheses. The attune primary total knee replacement system value. The attune total knee arthroplasty tka has been used in over 600 000 patients worldwide. Depuy will notify the fda of the results of this investigation once it has been completed.
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. Six vertical traces were acquired on both the backside and stem of. Attune knee system linked to improvements in patient. 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 attune knee replacements tibial loosening drugwatch. A depuy attune lawsuit may be an option for patients who have experienced early failure of their attune primary total knee system.
Genesis ii instrumentation has been developed to be an. At least one study found an unusually high failure rate for attune knee implants. Depuy attune knee implant failures continue sarasota. Once again depuy has knowingly continued to market a defective product to maximize profits and with no regard for their patients safety. Position the step drill to enter the intramedullary canal slightly superior and medial to the midline of the trochlea, 7 mm to 10 mm anterior to the origin of the pcl. Depuy attune knee system has unusually high early failure rate by law offices of jeffrey s. Revision surgical technique using sigma tc3 rp with mbt revision and stem. Please use one of the following formats to cite this article in your essay, paper or report. Register to receive a free us orthopedic large joint replacement device market report suite synopsis and brochure. 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 the study, recently published in the journal of knee surgery. Six vertical traces were acquired on both the backside.
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. Available with fixed bearing or rotating platform technology, the attune revision knee system is designed to. 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. Washington, university of pennsylvania and depuy orthopaedics, inc. The attune intuition instrumentation is unique in its ability to combine the surgical. If you have received an attune knee replacement system, you should know that. 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 challenges encountered by shoulder arthroplasty surgeons include surgical exposure, soft tissue balancing and component fixation. Contemporary total knee arthroplasty demands high performance instrumentation that provides enhanced efficiency, precision, and flexibility. The system encompasses implants and surgical instrumentation designed to work in harmony with your anatomy to deliver stability and motion.
Attune knee system surgical technique depuy synthes companies 5 pinning the attune knee system has 3. Electronic instructions for use depuy synthes companies. Unfortunately, many patients who underwent a total knee replacement procedure with depuy s attune knee replacement system are now looking forward to a revision surgery to have the device removed or repaired due to implant failures. The tibial base plate design of the attune knee system can lead to failure of the adhesive holding the implant to the tibia bone. Depuy attune knee system failures mcgartland law firm. Attune surgical technique guide surgical tech classes. The early clinical results of the attune knee are promising and include data from national registries, company initiated, independent studies, and investigator. 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. Since 2011, more than 700,000 total knee replacement surgeries have used depuy s attune knee implant worldwide. Depuy has found itself at the center of recall news in the past several years. The attune total knee arthroplasty tka has been used in over. Implant function is directly related to accurate surgical technique. Depuy attune knee replacement patients report tibial loosening.
Depuy synthes introduces attune revision knee system to provide. Depuy synthes continues to innovate around the attune knee platform, the surgical approach and digital surgery technologies, all with the goal of helping improve functional outcomes for patients, performance for surgeons and value for stakeholders. Lawsuit over alleged debonding hits depuys attune knee. 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. Guide, either perform a manual posterior resection or proceed to. The attune primary total knee system combines research into design, kinematics. 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. Trumatch solutions with attune knee system pin guide surgical trumatch solutions with attune knee system pin guide surgical technique. But hundreds of patients needed revision surgery after their attune implants. The intuition instruments combine the surgical process with intuitive and. View this document to learn more about the cementing. A study back in 2017 noted that the fdas manufacturer and user facility device experience maude database had hundreds of reports of adverse events regarding the depuy synthes attune knee implant, many of which necessitated revision surgery. This surgical technique provides guidelines for the implantation.
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. These advances have allowed the development of more efficient instrumentation and increasingly sophisticated implant designs that enhance clinical outcomes. The intuition instruments are designed to be used with the singleuse pin pack 254400111 that contains universal pins and threaded headed pins. The device is advertised as being able to give patients increased stability and range of motion following knee replacement procedures. Reports indicate that the attune knee implant, as well as knee implants manufactured by device makers arthrex and exactech, may cause patients to undergo revision surgeries and experience pain and other losses. Lawsuit over alleged debonding hits depuy s attune knee walter eisner tue, february 27th, 2018. Depuy attune knee component recall affects 3,500 devices. The attune primary total knee system is designed with the goal of addressing the clinical needs of. Significant bone loss requiring extensive reconstruction around the hip and knee is often required following the treatment of malignant bone tumors, aggressive benign bone tumors, infection, multiple revised and failed joint replacements and massive trauma, particularly in the elderly osteoporotic patient.
The attune knee by depuy synthes was introduced in 20. The intuition instruments are designed to be used with the. Knee implant patients furious at depuy attune failures. Depuy synthes introduces attune revision knee system to. Variability of plus or minus 15 degrees in both neck angle and version allow the surgeon to restore individual patient anatomy. Manufacturer narrative this complaint is still under investigation. Depuy synthes, based in warsaw, indiana, has announced updated clinical data for its attune knee system. Depuys attune knee replacement system failures leads to. We are fielding many inquiries from knee implant patients who have been injured by the best selling knee implant device made by johnson and johnson and its unit depuy orthopaedics. Many of them are furious at having to undergo painful risky kne. 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.
At golden state orthopaedics we believe that movement is the very foundation of peoples health and well being. Orthopedic surgeons and patients alike have complained of the unusually high premature failure rate of the implant. Pdf analysis of the attune tibial tray backside researchgate. About depuy synthes joint reconstruction confidence like. Depuy lps limb preservation system surgical technique. If information is obtained that was not available for the initial medwatch, a followup medwatch will be filed as appropriate. Pdf a comparison of clinical and patientreported outcomes of the. Depuy engineered its attune knee replacement to be one of the most advanced on the market. But patients have filed hundreds of reports claiming that the devices loosened. We acknowledge that the surgical implantation technique may affect. Depuy believes in an approach to knee arthroplasty that places equal importance on recovery, function and survivorship. Surgical technique cat no 906880050 or the depuy asr surgical technique cat no 999802280 for detailed instruction on acetabular implantation. The pinnacle acetabular cup system primary surgical technique has been developed in consultation with an. Instead, many patients implanted with the device reported spontaneous loosening or debonding as the surgical glue was not able to properly adhere the device to the bone.
The instruments, technique and components of this arthroplasty system are designed to address these challenges. Attune tka surgical procedure june 27th 20 part 2 visit for more information. The attune knee is a comprehensive, integrated knee system. This content is intended for health care professionals in the united states. Attune revision knee system fixed bearing surgical technique depuy synthes companies 3. Food and drug administration fda the attune system was introduced to. Watch this video to learn more about using the sigma tc3 rp with mbt for revision surgeries and stem extensions.
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. If that happens, attorneys may ask to combine them in a multidistrict litigation mdl. Its fully anatomic design and straightforward surgical technique assist the surgeon to achieve appropriate joint biomechanics, implant stability and range of motion for their patients. Thats why we provide medical professionals with the innovative products they need to assist them in treating their patients. Revision surgical technique using sigma tc3 rp with mbt.
1478 620 1323 897 487 491 260 1409 714 1068 1323 1299 1237 1008 1058 746 228 560 910 1515 970 478 1372 1094 1168 130 1017 1209 582 1417 365 1058 1060 1090 1114 686