The ATTUNE AFFIXIUM Knee is the first in the ATTUNE Knee portfolio to utilize this advanced 3D printing technology, which creates a three-dimensional lattice structure, generating a similar . Background Total Knee Arthroplasty (TKA) remains the gold standard for treatment of debilitating symptoms of knee osteoarthritis (OA). LCS Complete Knee System — Another product that can either be mobile bearing or fixed. Ankle Products. The ATTUNE® Knee is designed to optimize how your knee replacement feels and moves. Our primary objective is to compare our tibial aseptic loosening rate with previous reported studies. The DePuy Synthes (DS) ATTUNE® Knee System has been designed to improve patient function and satisfaction. ATTUNE® Knee System Femur First Anatomic Alignment DePuy Synthes Companies 5 Hip Knee Ankle (HKA) alignment angle is defined in this technique as the angle between the femoral mechanical axis and the tibial mechanical axis. DePuy Synthes, based in Warsaw, Indiana, has announced updated clinical data for its ATTUNE Knee System. The DePuy Synthes (DS) ATTUNE® Knee System has been designed to improve patient function and satisfaction. This stability is essential for activities like walking and going up and down stairs. GMDN Preferred Term Name GMDN Definition; Uncoated knee femur prosthesis, metallic An implantable device designed to replace the femoral condyles (femoral component) during primary bicondylar replacement of the knee joint, femoral bone resection, or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo . . . It is typically a one-piece contoured polyethylene (PE) insert . The DePuy Attune Knee was introduced in 2010 and a recent study finds a higher than normal device failure rate. Attune implants had the thinnest tray dimensions (median = 4.08 mm), followed by the PFC Sigma RP (median = 4.88 mm), and both the Ti and CoCr PFC Sigma designs (median = 6.36 mm and 6.39 mm, respectively). Scores are derived by a 5 digit code. Knee replacement lawsuits frequently claim the devices loosened or became so unstable they had to be replaced. 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. An angle of greater than 180 degrees is considered Valgus. The ATTUNE Knee is a comprehensive, integrated knee system. The recall affects approximately 3,500 units. Elizabeth Hofheinz, M.P.H., M.Ed. 2016; 136:1741-52. doi: 10.1007/s00402-016-2571-. The system includes a full compliment of implants designed to address the challenges faced in revision knee surgeries. "We continue to set a high bar for data-driven innovation in Total Knee Replacement (TKR) to improve patient satisfaction, while developing systems . Knee replacement surgeries employing the DePuy Synthes Attune Knee System have a higher than normal rate of failure, requiring revision surgery to be performed. a doctor could easily determine that she would need an Attune size 7.0 femoral component and an Attune 7.5 tibial component. However, the injury risk to the residual patella was increased with use of the Attune prosthesis in Asian patients. Mentioning: 2 - A595 the increased demand for TKAs, there is a need for meaningful innovation that improves clinical outcomes and optimises resource utilisation. The objective of this study was to compare length of stay (LOS) of TKA with ATTUNE . This study aimed to evaluate functional outcomes compared between the ATTUNE and PFC Sigma designs at a minimum follow-up of 5 years. Attune Knee System — A new, fixed bearing system from DePuy. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. "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 . 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. The company has just announced that implant survivorship data from the 2016 Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) confirm positive early results for the ATTUNE Knee. However, an unusually high rate of aseptic tibial tray loosening was observed in the DePuy ATTUNE . xvi. We then measured: 1) the size of tibial. Strengths and limitations: This is the first study investigating the Attune knee and its predecessor in terms of implant seating and press fit. THE SCIENCE BEHIND THE ATTUNE® CEMENTLESS KNEE SYSTEM 8mm 10mm 6mm In developing the ATTUNE®Cementless Knee, DePuy Synthes drew upon the successful clinical history of its Cementless and Rotating Platform Technologies, including the LCS COMPLETE™ Smith & Nephew - 139 recalls. The ATTUNE Knee System has 3.15 mm diameter pins to increase the stability and functionality of the instruments. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Through several key patented technologies, the ATTUNE Knee can help you achieve a range of motion while giving you the confidence of a stable knee replacement. We used a peer-reviewed digital imaging method to quantify the amount. The ATTUNE AFFIXIUM Knee is the first in the ATTUNE Knee portfolio to utilize this advanced 3D printing technology, which creates a three-dimensional lattice structure, generating a similar porosity to natural bone for advanced biological fixation xv and helps enhance initial implant stability. According to the agency's database, there were nearly 1,300 recalls on knee replacement systems or components between 2003 and 2019. The INTUITION SOLO Instruments are designed to be used with either Pin Packs (2544-00-120 or 2544-00-121) that contain a Pin Driver, Threaded Headed Pins, and either Universal Pins or Threaded Non-Headed Pins. Contact Us The Subject requires a device not specified in the protocol or the surgeon determines that the ATTUNE Knee System is not a suitable treatment. Of these, 62% (150/259) were women. DePuy Orthopaedics, Inc. has recalled a component of the Attune knee implant called the "balseal" — a small wire spring — that has potential to detach and lodge itself in the surgical site, unbeknownst to patients. The Attune Knee by DePuy Synthes is an advancement in knee replacement options. SIGMA or ATTUNE knee implant systems (DePuy Synthes). . tray . The ATTUNE Knee . Total knee replacement surgery, or knee arthroplasty, is performed on people with severe knee damage that causes them pain, interfering with or preventing normal movement and activity . In the largest knee replacement lawsuit settlement, Sulzer Medica paid $1 billion to settle 4,000 . The results also . Based on our clinical heritage, the central design of the ATTUNE Rotating Platform Tibial Base allows the tibial insert to rotate as the knee flexes, which allows for a more natural motion and may also reduce the stress and wear on the implant. The purpose of this retrospective study is to evaluate our short-term clinical and radiological results and survival using the ATTUNE Total Knee Replacement System. "The ATTUNE Knee represents the largest research and development project in the history of DePuy Synthes," said Rajit Kamal, vice president and global franchise leader, Knees, DePuy Synthes. Balancing the knee is a principal goal in total knee replacement, and can be impacted by femoral geometry and technique. Objectives: The Attune total knee arthroplasty (TKA) has been used in over 600 000 patients worldwide. xvi. The system is designed to address bone defects, provide stability, provide enhanced fixation options, and deliver an efficient technique. Small and consistent 3 mm A/P increments between sizes minimizes the effect on the fl exion gap in the case of up or down sizing. 7 This, along with the Natural-Knee ® II System, created the foundation for what would become the Persona Knee. Attune Knee System — A new, fixed bearing system from DePuy. Outcome Measures. Different Styles. Predecessor to the Persona System, the NexGen® Knee System is the most widely used and clinically proven total knee system in the world. The HKA angle is calculated by (F + T - X). 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 . The foam material is a . ATTUNE Revision LPS Insert with S-ROM® NOILES™ Rotating Hinge System and LPS System Surgical Technique DePuy Synthes 3 Distal Femur Replacement with LPS Knee System and ATTUNE Revision LPS Insert Pre-operative Planning 54 Exposure and Tibial Preparation 55 Femoral Preparation 56 Trialing 64 Trial Reduction 65 Trial Removal 66 The ATTUNE ® Knee System was designed to reduce pain and improve function, leading to greater patient satisfaction and decreased resource utilization in TKA. Patients will undergo a primary total knee replacement using one of the four implant configurations of the ATTUNE knee ( CR FB, CR RP, PS FB, PS RP). The DePuy Synthes Attune total knee arthroplasty (TKA) system has been the subject of hundreds of complaints to the FDA about the knee device's problems. Attune implants. Background: Although total knee arthroplasty (TKA) procedures are increasing, patient satisfaction is still inferior compared to total hip arthroplasty. A non-inferiority margin of 1.5% was assumed. | Find, read and cite all the research . "The ATTUNE AFFIXIUM Knee is a game changer . Anatomic dimensions of the patella measured during total knee arthroplasty. Total Knee System [17], [18]. An implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision bicondylar knee joint replacement. Registry data show good clinical outcome; however, concerns over the cement-tibial interface . The objective of this study was to compare the length of stay (LOS) for TKA patients who received ATTUNE versus the DS SIGMA . Arch Orthop Trauma Surg. The ATTUNE Revision system is complementary to the ATTUNE primary knee portfolio and includes both rotating platform (RP) and fixed bearing (FB) configurations. [Google Scholar] 19. The ATTUNE Knee System offers 10 standard and 4 narrow femoral sizes. Sigma Total Knee System — Available in fixed and mobile-bearing designs, this knee system covers a wide variety of patient and surgeon preferences. All implants were fixed-bearing, cruciate-retaining, and cemented constructs. One of the newest models is the ATTUNE knee system (DePuy, Warsaw, Indiana, USA). "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 . 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. Between January 2010 and December 2014, 100 consecutive Attune TKAs were matched to 100 PFC Sigma TKAs based on age, gender, side, and body mass index. Methods. This stability is essential for activities like walking and going up and down stairs. Sigma Total Knee System — Available in fixed and mobile-bearing designs, this knee system covers a wide variety of patient and surgeon preferences. ATTUNE®Knee System Femur First Anatomic Alignment DePuy Synthes Companies 9 3Pre-Operative Planning Step 2: Ensure that the HKA angle is not greater than 3 degrees Varus by adjusting the Tibial Joint Line Angle (T). We took the elements that made the NexGen Knee and Natural-Knee II Systems so successful and looked for ways to further enhance those designs. Confi dent implant positioning is the combination of multiple instrument options to give you the intra-operative fl exibility that you desire. Some new knee systems offer 1mm incremental insert thicknesses.63,64 However, the data from a competitor offers little evidence that these insert options address a clinical need.59 Zimmer's own data shows that as loads increase • Wed, May 30th, 2018. Key messages: The Attune implant showed incomplete seating because of too much press fit and an uneven bone quality or sclerosis can result in tilting of the tibial component. 2005; 20:250-7. doi: 10.1016 . While knee replacement is widely recognized as one of the most common and successful surgical procedures, approximately five percent of patients will require a revision surgery 10 years after the initial . Go to Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information. Total knee arthroplasty (TKA) systems are designed to maximize the longevity of the implant. Bleeding. DePuy has found itself at the center of recall news in the past several years. xvi The right and left femoral and tibial implants were the same size in 97% (155/259) of female patients and 90% (89/259) in males. Device Description: ATTUNE KNEE SYSTEM TIBIAL INSERT ROTATING PLATFORM POSTERIOR STABILIZED 8 5mm AOX CLOSE. We found considerable differences of the tibial component fit to the bone bed for Attune knee systems and the predecessor knee prostheses as well as tibial instrumentation options (cement mantle, line-to-line). Zimmer Biomet has faced more than 1,700 lawsuits over its NexGen implant. TRUMATCH Personalized Solutions (Knee) VELYS Hip Navigation; VELYS Robotic-Assisted Solution (Knee) Foot & Ankle. Knee Replacement Lawsuits. Please refer to Catalogue Number 0612-10-512 Rev.1 for the non- navigated surgical technique. SAN DIEGO, C.A., March 14, 2017 - Today, DePuy Synthes*, part of the Johnson & Johnson Family of Companies, released a new report, "Improving the Value of Primary Total Knee Arthroplasty: the ATTUNE® Knee System," that analyzes the ATTUNE Knee's current clinical and economic data. The Attune CR showed a 3 year cumulative percent revision for the cemented primary total knee replacement of 2.3% . Also, says the December 19, 2016 news release, "recently-presented interim data have shown improved patient reported outcomes measures . . The ATTUNE Revision Knee System was introduced at the 2018 American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting in New Orleans, LA. Get the Evidence DePuy Synthes Knee Solutions Key Resources FIBULINK® Syndesmosis Repair System; Headless Compression Screws; LCP® Distal Tibia T-Plate (3.5 mm) LCP® Low Bend Medial Distal Tibia Plates (3.5 mm) LCP® Medial Distal Tibia Plate, without tab (3.5 mm) LCP . Mean time until revision surgery time was 19 months. Knee replacement lawsuits claim the devices loosened, became unstable and required revision surgery to correct the problems. We report the early functional outcomes of an evolutionary knee design in the context of a single-blinded, noninferiority, randomized controlled trial. Thus the Attune CR fixed bearing total knee system exhibits 50% less overall mean gravimetric wear than the previously cleared DePuy Sigma Curved fixed bearing total knee system for the same composite thickness. The ATTUNE® Knee System is designed to provide improved functional outcomes and patient satisfaction, implant durability, and OR efficiency for all stakeholders. And lawyers report new cases claiming injuries from the DePuy Synthes Attune Knee implant and the first-generation Smith & Nephew Journey BCS knee system. . Through several key patented technologies, the ATTUNE Knee can help you achieve a range of motion while giving you the confidence of a stable knee replacement. Different Styles. PDF | Background Total Knee Arthroplasty (TKA) remains the gold standard for treatment of debilitating symptoms of knee osteoarthritis (OA). However, an unusually high rate of aseptic tibial tray loosening was observed in the DePuy ATTUNE . EQ-5D with 3 levels of severity for each of the 5 dimensions (EQ-5D-3L) [ Time Frame: 2 Years ] The ATTUNE Knee System is a new prosthetic design that has theoretical advantages over the Press Fit Condylar (PFC) Sigma Knee System specific to improved knee kinematics and patellofemoral joint tracking. WARSAW, IN, Sept. 9, 2019 - Johnson & Johnson Medical Devices Companies* announced today that DePuy Synthes** is launching the ATTUNE Cementless Knee in a rotating platform option in select markets around the world.This launch combines the proprietary technologies of the ATTUNE Knee designed to provide stability while the knee is in motion with DePuy Synthes' extensive heritage in rotating . Implant . J Arthroplasty. Methods The DePuy Synthes Attune Knee system was approved by the FDA in 2010, and placed on the market in March 2013. Mentioning: 2 - A595 the increased demand for TKAs, there is a need for meaningful innovation that improves clinical outcomes and optimises resource utilisation. The ATTUNE AFFIXIUM Knee is the first in the ATTUNE Knee portfolio to utilize this advanced 3D printing technology, which creates a three-dimensional lattice structure, generating a similar porosity to natural bone for advanced biological fixation xv and helps enhance initial implant stability. The objective of this study was to compare the length of stay (LOS) for TKA patients who received ATTUNE versus the DS SIGMA . measurements recorded for the femur included the overall ap and mediolateral (ml) widths, widths of the lateral condyle and the medial condyle, the distal condylar offset (dco) between the lateral and medial condyles in the superoinferior direction, and the posterior femoral offset (pfo) as the difference between the medial and lateral posterior … The companies with the most recalls have also faced significant numbers of lawsuits: Zimmer - 355 recalls. . ATTUNE Knee System Implants are available in four configurations: • Posterior Stabilized Fixed Bearing (PS FB), • Posterior Stabilized Rotating Platform (PS RP), • Cruciate Retaining Fixed Bearing (CR FB) and • Cruciate Retaining Rotating Platform (CR RP) LCS Complete Knee System — Another product that can either be mobile bearing or fixed. These implants include Stemmable tibial and femoral components . Methods: Patients were randomized to receive either the P.F.C. Attune Total Knee DePuy Orthopaedlics mg/million cycles while the Sigma mean gravimetric wear rate was 7.12 ± 1.2 mg/million cycles. The dimensions of the nine knee implant designs (Vanguard, Genesis II, Persona Standard, Persona Narrow, GK Sphere, Gemini, Attune Standard, Attune Narrow, and Sigma PFC) were compared with the patients' anthropometric (distal femur and proximal tibia) measurements. Primary -Complex Primary -Revision -Complex Revision -Limb Salvage Includes a wide range of product options for demand-matching to optimize solutions based on UOC Knee Franchise Overview 3 "An advanced knee arthroplasty portfolio" The consistent design philosophy allows a platform-based approach to provide surgeons flexibility for a wide range of procedures. The failure seems to be related to the cement which holds the device in place. The dimensions of the nine different knee implants (Vanguard, Persona Standard, and Persona Narrow from Zimmer Biomet, Warsaw, IN, USA; Genesis II from Smith & Nephew, London, UK; GK Sphere from Medacta, Castel San Pietro, Switzerland; Gemini from Waldemar Link, Hamburg, Germany, and PFC Sigma, Attune Standard, and Attune Narrow from DePuy Synthes, Warsaw, IN, USA) were collected from the . One of the landmark features is a gradually reducing radius in the geometry of the femoral component, more closely mimicking the anatomical patellofemoral joint and facilitating more natural femoral rollback during flexion. The knee joint bears loads that are several times the body weight. The Attune knee system provided slightly better clinical results than the PFC Sigma prosthesis in TKA. The ATTUNE Knee System delivers breakthrough discoveries that make the ATTUNE Knee an advancement for hospitals, patients, and surgeons. the science behind the attune® cementless knee system 8mm 10mm 6mm in developing the attune®cementless knee, depuy synthes drew upon the successful clinical history of its cementless and rotating platform technologies, including the lcs complete™ primary -complex primary -revision -complex revision -limb salvage includes a wide range of product … Labey L, Fuchs-Winkelmann S, Innocenti B. Fixation techniques and stem dimensions in hinged total knee arthroplasty: a finite element study. of cement attached to the backside of each tibial tray. Total costs for each surgery averaged to be more than $49,000. Even though providing satisfactory results for the majority of patients, some studies report dissatisfaction after TKA to be as high as 20%. The report concludes that in a value-based healthcare environment with cost constraints and growing . ATTUNE Knee System / Courtesy of DePuy Synthes. 10,11,12 Supporting Documentation Resources ATTUNE ® Knee Patient Resource Packet Download PDF Both implants were the same . According to the company, a multicenter study of 200 cases presented at the 2nd World Arthroplasty Congress in Rome on Patient . Among other things, pain catastrophising and self-efficacy are thought to compromise results of TKA. The angle is measured on the medial side of the limb. The ATTUNE AFFIXIUM Knee is the first in the ATTUNE Knee portfolio to utilize this advanced 3D printing technology, which creates a three-dimensional lattice structure, generating a similar porosity to natural bone for advanced biological fixation xv and helps enhance initial implant stability. Survival data of the LCS was extracted from a meta-analysis on long-term survivorship studies of the LCS TKA (mobile bearing cemented and uncemented implants) . Heart attack, stroke or lung complications (rare) Revision surgery rates for knee replacements are quickly rising. Depuy Attune, Zimmer NexGen and Arthrex iBalance are among the knee implants named in lawsuits. The Attune knee has an anatomic trochlear groove with a medialized dome patellar component vs the PFC Sigma with a single radius trochlear groove with a domed shaped patella. Euro Quality of life five Dimensions questionnaire five level (EQ5D-5L) at postoperative 2 years compared to pre-op baseline. . The results demonstrate that the correlations between shoe size and two of the four knee implant dimensions - TAP and TML - are higher than the correlations between height and the same dimensions. Bonutti et al. Even though. In 2010, more than 55,000 revision surgeries were performed in the U.S., with 48 percent of the revisions in patients under 65. The ATTUNE® Knee is designed to optimize how your knee replacement feels and moves. Total knee arthroplasty (TKA) systems are designed to maximize the longevity of the implant. The ATTUNE Knee . Attune and Attune S+ with line to line preparation: • 3 mm radius − 0 mm cement mantle = 3 mm radial press fit respectively with maximum incomplete seating of 3.0 mm. Gililland JM, Gaffney CJ, Odum SM . Amid aggressive marketing, the system quickly became widely used in the knee . reported 15 cases of early aseptic loosening of the ATTUNE tibial component with failure of the cement-metal interface [13]. DePuy expanded the TKA portfolio with the ATTUNE knee system, consisting of the regular ATTUNE and the ATTUNE S+ component. Each of these significant technologies was designed to . "The ATTUNE AFFIXIUM Knee is a game changer . DePuy - 346 recalls. [ Time Frame: Pre-operative and post-operative 2 years. Sample size calculation was aimed at non-inferiority of the Attune knee compared to the LCS knee, the predecessor of the Attune.