This stability is essential for activities like walking and going up and down stairs. [Google Scholar] 19. However, the injury risk to the residual patella was increased with use of the Attune prosthesis in Asian patients. Euro Quality of life five Dimensions questionnaire five level (EQ5D-5L) at postoperative 2 years compared to pre-op baseline. 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™ Bleeding. The objective of this study was to compare the length of stay (LOS) for TKA patients who received ATTUNE versus the DS SIGMA . 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. 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) . Objectives: The Attune total knee arthroplasty (TKA) has been used in over 600 000 patients worldwide. The ATTUNE Knee System has 3.15 mm diameter pins to increase the stability and functionality of the instruments. We report the early functional outcomes of an evolutionary knee design in the context of a single-blinded, noninferiority, randomized controlled trial. 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. The knee joint bears loads that are several times the body weight. 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) Depuy Attune, Zimmer NexGen and Arthrex iBalance are among the knee implants named in lawsuits. Amid aggressive marketing, the system quickly became widely used in the knee . 2005; 20:250-7. doi: 10.1016 . The ATTUNE® Knee is designed to optimize how your knee replacement feels and moves. Predecessor to the Persona System, the NexGen® Knee System is the most widely used and clinically proven total knee system in the world. Ankle Products. 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 HKA angle is calculated by (F + T - X). The ATTUNE Knee System offers 10 standard and 4 narrow femoral sizes. 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. 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. And lawyers report new cases claiming injuries from the DePuy Synthes Attune Knee implant and the first-generation Smith & Nephew Journey BCS knee system. The ATTUNE Knee is a comprehensive, integrated knee system. . Implant . In the largest knee replacement lawsuit settlement, Sulzer Medica paid $1 billion to settle 4,000 . 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 . All implants were fixed-bearing, cruciate-retaining, and cemented constructs. Heart attack, stroke or lung complications (rare) Revision surgery rates for knee replacements are quickly rising. 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. TRUMATCH Personalized Solutions (Knee) VELYS Hip Navigation; VELYS Robotic-Assisted Solution (Knee) Foot & Ankle. 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 . The system includes a full compliment of implants designed to address the challenges faced in revision knee surgeries. We then measured: 1) the size of tibial. 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). Anatomic dimensions of the patella measured during total knee arthroplasty. Go to Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information. Among other things, pain catastrophising and self-efficacy are thought to compromise results of TKA. reported 15 cases of early aseptic loosening of the ATTUNE tibial component with failure of the cement-metal interface [13]. Strengths and limitations: This is the first study investigating the Attune knee and its predecessor in terms of implant seating and press fit. 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. . Background: Although total knee arthroplasty (TKA) procedures are increasing, patient satisfaction is still inferior compared to total hip arthroplasty. 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 . 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. 7 This, along with the Natural-Knee ® II System, created the foundation for what would become the Persona Knee. a doctor could easily determine that she would need an Attune size 7.0 femoral component and an Attune 7.5 tibial component. 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. However, an unusually high rate of aseptic tibial tray loosening was observed in the DePuy ATTUNE . "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 . 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. 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. Please refer to Catalogue Number 0612-10-512 Rev.1 for the non- navigated surgical technique. Scores are derived by a 5 digit code. 10,11,12 Supporting Documentation Resources ATTUNE ® Knee Patient Resource Packet Download PDF 2016; 136:1741-52. doi: 10.1007/s00402-016-2571-. Smith & Nephew - 139 recalls. Our primary objective is to compare our tibial aseptic loosening rate with previous reported studies. Zimmer Biomet has faced more than 1,700 lawsuits over its NexGen implant. The foam material is a . Mean time until revision surgery time was 19 months. Methods. The ATTUNE Knee . The objective of this study was to compare the length of stay (LOS) for TKA patients who received ATTUNE versus the DS SIGMA . 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 . According to the company, a multicenter study of 200 cases presented at the 2nd World Arthroplasty Congress in Rome on Patient . The ATTUNE® Knee is designed to optimize how your knee replacement feels and moves. Gililland JM, Gaffney CJ, Odum SM . 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 … 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. Different Styles. The Attune knee system provided slightly better clinical results than the PFC Sigma prosthesis in TKA. The failure seems to be related to the cement which holds the device in place. 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 took the elements that made the NexGen Knee and Natural-Knee II Systems so successful and looked for ways to further enhance those designs. 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. Bonutti et al. 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. DePuy - 346 recalls. 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 delivers breakthrough discoveries that make the ATTUNE Knee an advancement for hospitals, patients, and surgeons. The DePuy Attune Knee was introduced in 2010 and a recent study finds a higher than normal device failure rate. Knee replacement lawsuits claim the devices loosened, became unstable and required revision surgery to correct the problems. | Find, read and cite all the research . 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. • Wed, May 30th, 2018. SIGMA or ATTUNE knee implant systems (DePuy Synthes). 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 . The DePuy Synthes Attune Knee system was approved by the FDA in 2010, and placed on the market in March 2013. The ATTUNE Knee . The DePuy Synthes (DS) ATTUNE® Knee System has been designed to improve patient function and satisfaction. Sigma Total Knee System — Available in fixed and mobile-bearing designs, this knee system covers a wide variety of patient and surgeon preferences. "The ATTUNE AFFIXIUM Knee is a game changer . In 2010, more than 55,000 revision surgeries were performed in the U.S., with 48 percent of the revisions in patients under 65. It is typically a one-piece contoured polyethylene (PE) insert . DePuy Synthes, based in Warsaw, Indiana, has announced updated clinical data for its ATTUNE Knee System. Contact Us 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). Also, says the December 19, 2016 news release, "recently-presented interim data have shown improved patient reported outcomes measures . Arch Orthop Trauma Surg. Outcome Measures. Background Total Knee Arthroplasty (TKA) remains the gold standard for treatment of debilitating symptoms of knee osteoarthritis (OA). Attune Total Knee DePuy Orthopaedlics mg/million cycles while the Sigma mean gravimetric wear rate was 7.12 ± 1.2 mg/million cycles. The DePuy Synthes (DS) ATTUNE® Knee System has been designed to improve patient function and satisfaction. Balancing the knee is a principal goal in total knee replacement, and can be impacted by femoral geometry and technique. 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). Device Description: ATTUNE KNEE SYSTEM TIBIAL INSERT ROTATING PLATFORM POSTERIOR STABILIZED 8 5mm AOX CLOSE. 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. The ATTUNE Revision Knee System was introduced at the 2018 American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting in New Orleans, LA. Primary -Complex Primary -Revision -Complex Revision -Limb Salvage Includes a wide range of product options for demand-matching to optimize solutions based on The system is designed to address bone defects, provide stability, provide enhanced fixation options, and deliver an efficient technique. 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. The Subject requires a device not specified in the protocol or the surgeon determines that the ATTUNE Knee System is not a suitable treatment. xvi. [ Time Frame: Pre-operative and post-operative 2 years. 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). An angle of greater than 180 degrees is considered Valgus. The angle is measured on the medial side of the limb. . 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. EQ-5D with 3 levels of severity for each of the 5 dimensions (EQ-5D-3L) [ Time Frame: 2 Years ] The report concludes that in a value-based healthcare environment with cost constraints and growing . . 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. This study aimed to evaluate functional outcomes compared between the ATTUNE and PFC Sigma designs at a minimum follow-up of 5 years. 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 . Total knee arthroplasty (TKA) systems are designed to maximize the longevity of the implant. The ATTUNE® Knee System is designed to provide improved functional outcomes and patient satisfaction, implant durability, and OR efficiency for all stakeholders. 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 "We continue to set a high bar for data-driven innovation in Total Knee Replacement (TKR) to improve patient satisfaction, while developing systems . According to the agency's database, there were nearly 1,300 recalls on knee replacement systems or components between 2003 and 2019. . Mentioning: 2 - A595 the increased demand for TKAs, there is a need for meaningful innovation that improves clinical outcomes and optimises resource utilisation. Each of these significant technologies was designed to . The Attune CR showed a 3 year cumulative percent revision for the cemented primary total knee replacement of 2.3% . Both implants were the same . Mentioning: 2 - A595 the increased demand for TKAs, there is a need for meaningful innovation that improves clinical outcomes and optimises resource utilisation. Knee replacement lawsuits frequently claim the devices loosened or became so unstable they had to be replaced. 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. Knee Replacement Lawsuits. 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 . Total knee arthroplasty (TKA) systems are designed to maximize the longevity of the implant. Methods PDF | Background Total Knee Arthroplasty (TKA) remains the gold standard for treatment of debilitating symptoms of knee osteoarthritis (OA). 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 results also . 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 . Attune Knee System — A new, fixed bearing system from DePuy. Total costs for each surgery averaged to be more than $49,000. The ATTUNE Revision system is complementary to the ATTUNE primary knee portfolio and includes both rotating platform (RP) and fixed bearing (FB) configurations. The recall affects approximately 3,500 units. 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. Get the Evidence DePuy Synthes Knee Solutions Key Resources 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. An implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision bicondylar knee joint replacement. A non-inferiority margin of 1.5% was assumed. Total Knee System [17], [18]. Labey L, Fuchs-Winkelmann S, Innocenti B. Fixation techniques and stem dimensions in hinged total knee arthroplasty: a finite element study. Knee replacement surgeries employing the DePuy Synthes Attune Knee System have a higher than normal rate of failure, requiring revision surgery to be performed. 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 companies with the most recalls have also faced significant numbers of lawsuits: Zimmer - 355 recalls. The objective of this study was to compare length of stay (LOS) of TKA with ATTUNE . LCS Complete Knee System — Another product that can either be mobile bearing or fixed. xvi. Attune implants. 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. These implants include Stemmable tibial and femoral components . . The Attune Knee by DePuy Synthes is an advancement in knee replacement options. However, an unusually high rate of aseptic tibial tray loosening was observed in the DePuy ATTUNE . DePuy expanded the TKA portfolio with the ATTUNE knee system, consisting of the regular ATTUNE and the ATTUNE S+ component. xvi This stability is essential for activities like walking and going up and down stairs. . Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. 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 .
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