While this firm maintains joint responsibility of the content on this website many of these types of cases are referred to other attorneys for principal responsibility. available at Zimmer Biomet. "In addition to the spike-keel design, the Persona OsseoTi Keel Tibia offers the added convenience of a new cemented option with the same bone prep as the cementless option so that surgeons can make an intraoperative decision between a cementless or cemented approach based on bone quality and the unique needs of their patient.". 424 0 obj
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Australian Orthopaedic Association National Joint Total knee replacement surgery boasts high success rates and the majority of knee implants are estimated to last more than two decades. Femur specs:Anatomic design with21 distinct profilesin2mm The EuroQol 5-dimension (EQ-5D) is a generic questionnaire that measures the overall health-related quality of life. Side effects of failed Zimmer Persona knee implants reported by patients and their doctors include: When a knee implant fails the need for a second surgery, also called a replacement surgery or revision surgery, may be necessary. When there are less than five tibia-bone markers and less than five femur-bone markers visible in the baseline RSA photograph and it will not improve by placing the patient in another position, the patient will be excluded from the study (secondary exclusion criteria). This may result in knee pain and limited knee function. design locking mechanism, no lock-down screws or through holds, made ofTivaniumAlloy. Those studies that do exist have usually been undertaken to address a combination of design changes and many involve only short-term assessments (Mkel et al. The research assistant handling both standard RSA as well as dynamic RSA analysis is also unaware of which prosthesis the participant has received. Persona OsseoTi is the latest addition to the clinically proven Persona Knee System, and features a new porous version of the Persona anatomic tibia with Zimmer Biomet's OsseoTiPorous Metal Technology, which uses anatomical data in combination with 3D printing technology to build a structure that directly mimics the architecture of human cancellous or spongey bone. Zimmer, Inc. 1800 West Center Street Warsaw, Indiana 46580USA. Please remove one or more studies before adding more. These options found within the Persona Knee Systems The objective of this study is to accurately assess and compare migration, kinematics, prosthesis placement and patient reported outcomes of two TKR prostheses: the fixed bearing, cemented NexGen LPS, a proven design with an excellent clinical track record, and the fixed bearing, cemented Persona PS, a new design without clinical data (both designs by Zimmer, Warsaw, Indiana, USA). What was the ethnicity and gender of the Charnley J. Arthroplasty of the hip. The companies with the most recalls have also faced significant numbers of lawsuits: Zimmer - 355 recalls. An interactive learning environment for enhancing education and training. provide a portfolio of personalized knee care in order toreplicate a Thanks to advances in technology and surgical techniques, the majority of knee replacements are successful and provide extensive pain relief to patients. 1961). It is the responsibility of the primary investigator that the information to the participant is adequate. Radiographically verified radiolucency / osteolysis. We do not use cookies for targeted or behavioral advertising on this website. "Adding the Persona OsseoTi Keel Tibia to our well-established and clinically proven Persona Knee System allows surgeons to better address the needs of their patients with a comprehensive single system solution for a cementless or cemented application. Ongoing research and development programs for knee replacement are increasingly taking account of the needs of the changing characteristics of the late stage OA knee population. With more medial stability and lateral mobility, the Persona Medial Congruent Bearing is the most kinematic-friendly bearing Zimmer Biomet has designed. For example, womens body shapes differ from that of men, resulting in a slightly different range of motion. One design change that is introduced is the medial congruent (MC) polyethylene to be used instead of standard cruciate retaining (CR) design. repetitive use. Annual Report. Arthritis is characterized by inflammation and stiffness in the joints and can reduce a persons range of motion. Within Total knee arthroplasty, design changes are introduced in attempt to improve knee kinematics, improve alignment and functionality, but those potential improvements need to be evaluated Recently, Zimmer-Biomet have introduced Persona Total Knee system with design changes that include asymmetric tibia plate, increased medial pivoting and more extensive choices in respect to poly thickness, all with the purpose to improve balancing, stability and longevity. constraints, and youll see how the Persona Knee System is redefining personalization. Depuy Attune, Zimmer NexGen and Arthrex iBalance are among the knee implants named in lawsuits. knee design. Catalog excerpts. Studies have shown that modern implant designs can potentially improve outcome. A total score ranging from 0 (worst) to 100 (best) is calculated. the resected bone? 7h. Therefore such design changes and proposed benefits need to be evaluated in a prospective clinical trail, with focus on patient safety, satisfaction and implant durability. Talk with your doctor and family members or friends about deciding to join a study. While symmetric and asymmetric tibial designs had long Knee replacement is an established treatment for late stage osteoarthritis (OA) of the knee (Charnley et al. The NexGen TKR (Zimmer, Warsaw, Indiana, USA) is a proven TKR design that has reported excellent medium and long-term results in clinical studies and in implant registries all around the world. Both standard as well as narrow femoral components will be used, depending on the patient anatomy. patient satisfaction, and long-term survivorship. 409 0 obj
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Recently, Zimmer-Biomet have introduced Persona Total Knee system with design changes that include asymmetric tibia plate, increased medial pivoting and more extensive choices in respect to poly thickness, all with the purpose to improve balancing, stability and longevity. Joint Replacement | Orthopaedic Devices | Hip | Knee | Shoulder 1961 May 27;1(7187):1129-32. doi: 10.1016/s0140-6736(61)92063-3. satisfaction. After the FDA initiated the class II recall of the uncemented Persona implant in 2015, patients began filing lawsuits against Zimmer Inc. over the new device. Quickly find individual products and their details. Wear5and Improved strength.6,7, Highly porous material designed to replicate the structure, function Trabecular Metal is made from the element tantalum. AOA 2016: Table KT11 Cumulative Percent Revision The manufacturer, Zimmer, says its recall is voluntary. A total of 60 participants are to be included at Hvidovre University Hospital. 2008 Oct;90(10):2160-70. doi: 10.2106/JBJS.G.00870. Keywords provided by R.G.H.H. The theoretic proposed benefit of MC polyethylene bearing is improved kinematics mimicking native knee motion. As a follow-up of the NexGen TKR, an improved design has recently been introduced by Zimmer: The Persona TKR (Zimmer, Warsaw, Indiana . In vivo kinematics by means of fluoroscopy. Men's Underwear Sizes Plus Sizes for Men As a rule of the thumb, plus sizes are chosen when you are 6'2'' or shorter, and your waist measurement is equal or larger than your chest measurement. without the express written consent of Zimmer Biomet. postoperatively, we believe a system needs to include implants that All measurements in inches. Instrumentation and technology really matters. The oral information is in accordance with the written information and is adjusted to the age, educational level and social conditions of the participant. most widely used and clinically proven total knee system in the Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568123. In the largest knee replacement lawsuit settlement, Sulzer Medica paid $1 billion to settle 4,000 hip and knee implant cases. for each patient and restore the unique identity of every knee anatomy. In a market focused on matching the bone to the implant shape and FAQs About Bravelle Is there a reimbursement lawsuit? This field is for validation purposes and should be left unchanged. Tibial component: Only cemented tibial components will be used for this study. 00:00. The settlement averaged $200,000 per patient. reproduce the original. Knee. Recruitment of participants to this project is expected to begin in October 2016 or as soon as permission from the Regional Ethics Committee and the Danish Data Protections Agency is obtained. Considering this success rate, it came as a shock when a new-generation knee implant manufactured by one of the largest orthopedic companies in the world was recalled due to device failure merely three years after it was introduced to the market. Persona The Personalized Knee is designed to help the surgeon accomplish these goals by combining alignment accuracy with a simple, straight-forward technique. A total of 60 participants are to be included at Hvidovre University Hospital. Annually 40 TKA procedures are performed in our department, of which about 70% is Osteo Arthritis (OA) and 30% Reumatoid Arthritis (RA). These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet's filings with the SEC. BMC Res Notes. Nelissen, Prof. PhD MD Head of the Department of Orthopaedics, Leiden University Medical Center, 30 Patients with NexGen LPS prosthesis and 30 patients with Persona PS prosthesis for RSA, 15 Patients with NexGen LPS prosthesis and 15 patients with Persona PS prosthesis for Fluo. If your measurements fall between two sizes, we recommend to select the larger size (but you may try both sizes on if possible). This project is financed by Zimmer-Biomet, Warsaw, Indiana, USA. How to Order To order, call Zimmer Dental Customer Service between 6:00 a.m. and 4:30 p.m. PST, Monday through Friday, or fax your order to 1 (888) 225-2483. Only cemented tibial components will be used for this study. wanted you to have instruments that feel good in your hand after National Injury Help Staff Bios, who we are. Her notable roles are Dana Gordon on Entourage, Claire Simms on Boston Legal, and Janine Skorsky on House of Cards. Our legacy continues to come to life today through our progressive culture of evolution and innovation. were designed to help youconsistently achieve optimal US Size. Anti Slip Coating UAE 7d. These components can be made from several different materials. provide:Exceptional Oxidative Stability4, Ultra-low Participant population in Denmark Study population will consist of 60 participants with knee osteoarthritis set to receive primary total knee arthroplasty. Geerdink CH, Grimm B, Vencken W, Heyligers IC, Tonino AJ. Fit really matters. The Persona Revision Knee System expands the Persona Knee System to Nicoll, D. and It is particularly porous and allows for enhanced bone ingrowth, according to the Zimmer Persona website. If publication is not achieved, the results of this project (positive, negative or inconclusive) will be presented on the homepage of the investigator's institution. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers. Adelaide. Zimmer Inc., based in Warsaw, Ind., was founded more than 80 years ago and is now one of the largest orthopedic device companies in the world. Radiologically verified stability and fixation is measured as the Maximum total point motion (MTPM) using RSA. Vivacit-E Vitamin-E Highly Crosslinked Polyethylene Risk of dislocation using large- vs. small-diameter femoral heads in total hip arthroplasty. in the event of deep infection leading to replacement of the prosthesis or long-term immobilization because of comorbidity. 2.1mm-3.6mm* Tapered Screw-Vent Implant Dimensions Crestal Options Tapered Screw-Vent Implant Model: TSV Model: TSVT 1.8mm Fully Textured Microgrooves Model: TSVM 1.8mm Fully Textured Microgrooves Note: 4.1mmD Tapered Screw-Vent Implant Shown. %%EOF
Listing a study does not mean it has been evaluated by the U.S. Federal Government. Participants are informed that a period of consideration of at least 2 weeks is an opportunity along with the right to a second consultation. Could we be more bone conserving? Fit really matters. Australian Orthopaedic Association The knee is the bodys largest joint. 7i. The Persona OsseoTi Keel Tibia is also complemented with a new cemented implant option to enable seamless versatility for the surgeon during the procedure. * While the implant platform color code for the 4.1mmD Tapered Screw-Vent implant is green, the implant surgical sequence is color-coded white on the surgical kit surface. satisfaction is to more closely reproduce the original.. each procedure. Zimmer Biomet isaglobal medical technology leader with a comprehensive portfolio designed to maximize mobility and improve health. information.To obtain a copy of the current Instructions for Use hb```f``Jc`e``fd@ AFKjKCdV00xIFSCNU({G6 -, All Zimmer Dental catalogs and technical brochures, SAFESCRAPER TWIST Cortical Bone Collector, THE CHAIRSIDE ATTACHMENT PROCESSING MATERIAL, Packaging for Zimmer One-Piece Implants, SwissPlus Implant System Product Catalog, Trabecular MetalTM Dental Implant Brochure. , This material is intended for health care professionals. %PDF-1.6
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Orthopaedic Association National Joint Replacement Registry. There is an increasing demand for joint replacement in a younger population (Mkel et al. Studies have shown that 15%-39% of patients who undergo total knee surgery are not satisfied with the outcome. With over 15 years and over 3 million implantations worldwide, Triathlon has a long clinical history. The study's primary outcome measure is implant migration measured by RSA. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Makela KT, Eskelinen A, Pulkkinen P, Paavolainen P, Remes V. Total hip arthroplasty for primary osteoarthritis in patients fifty-five years of age or older. This project is carried out as a 2-arm randomized controlled single-blinded trial, in which the clinical and radiological outcomes after treatment of knee osteoarthritis with insertion of either 1) Persona Total Knee System with MC polyethylene bearing or 2) Persona Total Knee System with CR polyethylene bearing are compared. Why Should I Register and Submit Results? These complications can include infection and blood clots. Before you decide, ask us to send you free written information about the qualifications and experience of our sponsoring firms. Adult Reconstruction and Joint Replacement Service Primary Total Knee Arthroplasty with Zimmer Biomet Persona Personalized Knee System (Cadaveric) Orthopaedic Surgical Videos 15.9K subscribers. Number of participants Patients at are randomized to receive either 1) Persona Total Knee System with MC polyethylene bearing or 2) Persona Total Knee System with CR polyethylene bearing. This will insure sufficient statistical power despite intraoperative exclusion and dropout of 40% at last follow-up and . Zimmer Persona Surgical Technique (97-5026-001-00) for the Persona implant family. 2023All rights reserved This project will be notified to and approved by the Danish Data Protection Agency before recruitment of participants is initiated. WARSAW, Ind., Nov. 21, 2022 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the Persona OsseoTi Keel Tibia for cementless knee replacement. The research assistant handling both standard RSA as well as dynamic RSA analysis is also unaware of which prosthesis the participant has received, A Prospective Randomized Control Study on CR vs MC Polyethylene Bearing With Persona Total Knee System in Total Knee Arthroplasty, Active Comparator: CR polyethylene bearing, 18 Years and older (Adult, Older Adult), Anders Troelsen, Professor, Hvidovre University Hospital. Please remove one or more studies before adding more. In the 1990s, Zimmer introduced a line of total knee replacement devices, called NexGen, which helped pave the way for newer versions of its prosthetics that did not require clinical data for FDA approval. Orthopaedics, Leiden University Medical Center, R.G.H.H. Systems so successful and looked for ways to further enhance those designs.. 0
Between 1997 and 2009, the number of knee replacements jumped more than 80%, helping to make total knee replacements one of the most common surgical procedures in the US. Market Strategies International. For general information, Learn About Clinical Studies. No abstract available. (IFU) for full prescribing and risk information, please call 1-800-348-2759, press 4 for 411 Technical Support., Quantifying Your Patient Recovery with ZBEdges Persona IQ and the mymobility Care Management Platform, AAOS Las Vegas 03.08.23, Dealers Choice: ORIF vs. Total Hip Replacement AAOS Las Vegas 03.08.23, Zimmer Biomet Announces Fourth Quarter and Full-Year 2022 Financial Results, Zimmer Biomet Announces Webcast and Conference Call of Fourth Quarter 2022 Financial Results, Cemented and cementless total knee arthroplasty, Cruciate retainingand cruciatesacrificing options. How to Order To order, call Zimmer Dental Customer Service between 6:00 a.m. and 4:30 p.m. PST, Monday through Friday, or fax your order to 1 (888) 225-2483. Women's US Clothing Size Chart (CM): It is made up of the lower end of the thighbone (femur), the upper end of the shinbone (tibia) and the kneecap (patella). Most knee pain is caused by three types of arthritis, according to the American Academy of Orthopaedic Surgeons (AAOS), including osteoarthritis, rheumatoid arthritis and post-traumatic arthritis. While you can expect excellent implant survivorship with many of Persona Trocar Tipped Drill Pins (2.5 hex) (00-5901-020-00) Seemlessly connect, products, services and technologies to elevate options including minimal constraint to full constraint, left and We seamlessly transform the patient experience through our innovative products and suite of integrated digital and robotic technologies that leverage data, data analytics and artificial intelligence. Amanda Pedersen | Aug 30, 2021. Study record managers: refer to the Data Element Definitions if submitting registration or results information. The lawyers at National Injury Help are currently accepting cases for a Zimmer Persona Knee Implant Lawsuit involving the uncemented Trabecular Metal Tibial Plate component. Project information is then given in an undisturbed environment (in a closed examination room) by an authorized investigator of this project. Trabecular Metal Dental Implants - Fully Textured with Microgrooves (Model TMT) 3.5mmD Platform with a 2.5mmD Internal Hex 3.5mmD Platform with a 2.5mmD Internal Hex 4.5mmD Platform with a 2.5mmD Internal Hex 5.7mmD Platform with a 3.0mmD Internal Hex 1.8mm Microgrooves, MTXSurface 1.9mmL-3.4mmL Triple-Lead Thread (1.8mmL Lead), MTXSurface * Dimension varies by implant length. Doctors determine whether or not a total knee replacement is necessary based a patients pain and disability, not age or weight. Tapered Screw-Vent Implant System Product Catalog. Persona the Personalized Knee Surgical Technique - Zimmer Biomet Check the appropriate knee implant size matching chart for .. size, we found that the opposite needed to happen we need to match The project will be reported to the Danish Data Protection Agency. The patients will be followed for survival through The Danish Knee Arthroplasty Registry. See our US Plus Size Chart. mmincrements available in standard andnarrow provide the most Choosing to participate in a study is an important personal decision. Persona Ti-Nidium Femoral Components can be differentiated from CoCr components Weight 0.1310 kg - 0.3933 kg (0.29 lb - 0.87 lb) 0.0681 kg - 0.2031 kg (0.15 lb - 0.45 lb) Persona Tinidium Femoral Components are around 50% of the weight of CoCr Components Sizing Narrow:1-11 Standard: 1-12 Narrow:1-6 Standard: 4-12 Persona Ti-Nidium Implants include Patients with insufficient posterior cruciate ligament (PCL) and other patients unsuited for a CR implant receive a posterior stabilized (LPS) NexGen TKA. needs of each patient with our proven technology. Stemmed Tibial Sizing Plate. 384 0 obj
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Volume 90%. a NexGen knee, 1 in 5 knees implanted Tapered Screw-Vent implants Features/ Benefits Platform Plus Technology Creates favorable conditions for bone-level maintenance1-5 Lead-in Bevel - designed to reduce horizontal stresses better than flat butt-joint connections5'* Friction-Fit Connection - virtually eliminates abutment micromovement associated with screw loosening5 1.5mm Deep Internal Hex - shields the abutment retention screw from excess loading, distributing occlusal forces deep into the implant5 Designed for flexibility A two-stage or single-stage implant system Various coronal configurations including Zimmer Trabecular Metal Implant Dimensions Crestal Options Trabecular Metal Dental Implant 0.5mm Machined 0.5mm MTX Surface 1.8mm Microgrooves, MTXSurface Note: 4.7mmD Trabecular Metal Implant Shown. comprehensive femoral sizing scheme on the market. Recruitment is expected completed after a period of 1.5 year. ~(uw?Wv(y!!5MQTn%QcxM~ A computer-generated random allocation sequence will be used. 2008). Altered pain perception and / or neurologic affection due to diabetes or other disorders. found at http://www.odep.org.uk. patients arent fully satisfied with the feel of their new knee.1-3. The results of this project are also expected presented at national and international orthopedic conventions. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks, uncertainties and changes in circumstances that could cause actual outcomes and results to differ materially. The purpose of the proposed Randomized Clinical Trial (RCT) is to evaluate the outcome and safety of a newly designed polyethylene bearing by comparing it with a control group of patients implanted with an established polyethylene bearing. iData on file with Zimmer Biomet: The Persona OsseoTi Keel Tibia Provides Strong Initial Fixation. 2009). In 2000, the Swiss company recalled thousands of hip implants that had been tainted with a lubricant. Our General US Size Chart works with most clothing brands and manufacturers, but maybe not all. Smith & Nephew - 139 recalls. For more information about our product portfolio, our operations in 25+ countries and sales in 100+ countries or about joining our team, visitwww.zimmerbiomet.comor follow Zimmer Biomet on Twitter atwww.twitter.com/zimmerbiomet. Patients will be excluded intraoperative if CR implant is not suitable. It is also recognized that the investigator, at his/her discretion, may withdraw a subject from this study based upon his/her professional judgment, e.g. in the event of deep infection leading to replacement of the prosthesis or long-term immobilization because of comorbidity. By addressing those opportunities in the Persona Knee, we believe Wiper Size Guide First select your car make: Acura Alfa Romeo AM General American Motors Aston Martin Asuna Audi Austin Avanti Bentley Bertone BMW Buick. It is recognized that the subject's participation in this study is entirely voluntary, and that she/he may refuse to participate and may withdraw from participation at any time without jeopardy to any future medical care. Cadillac Checker Chevrolet Chrysler Citroen Coda Daewoo Daihatsu DeLorean DeSoto Dodge Eagle Edsel. Zimmer Biomet Persona Total Knee System with CR polyethylene bearing. Rowley, D. Internal rotational error of the tibial component is a Migration (MTPM in mm) of the prosthesis with respect to the host bone measured by means of roentgen stereophotogrammetric analysis (RSA). View this study on Beta.ClinicalTrials.gov. You have reached the maximum number of saved studies (100). With more medial stability and lateral mobility, the Persona Medial Knee implants, like the Zimmer Persona, are made up of three different components, including the femoral component, the tibial component and a plastic spacer that acts as the menisci. It is ensured that the participant has understood the content of both the oral and written information before signed consent is given. Non-transparent envelopes are used for the randomization process. Therefore such design changes and proposed benefits need to be evaluated in a prospective clinical trail, with focus on patient safety, satisfaction and implant durability. So we studied the shapes and sizes of the hand to Recruitment is expected completed after a period of 1 year. System, created the foundation for what would become the Persona Knee. percent of painfulTotal Knee Arthroplasty (TKA) Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. intellectual property rights, as applicable, owned by or licensed to The Zimmer Persona was approved by the FDA through its 510(k) approval process in late 2012, nearly two decades after Zimmers NexGen line was introduced in 1995. Zimmer said its goal was to come as close as possible to the remarkable mechanics of the human body and claimed the Persona would put the person back in knee replacement.. Participants are unaware of which prosthesis they receive and the research coordinator handling the collected questionnaires postoperatively is also unaware of which prosthesis the participant has received. The project is expected to be completed 2 years after recruitment of the last participant (2019).