zimmer persona size chart

The manufacturer, Zimmer, says its recall is voluntary. 384 0 obj <> endobj 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. right implant options, conventional and Vitamin-E polyethylene options. According to the agency, 11,658 devices are affected by the recall. not be redistributed, duplicated or disclosed, in whole or in part, During total knee replacement, surgeons remove damaged cartilage and bone from the ends of the femur and tibia and replace these parts with metal components. provide a portfolio of personalized knee care in order toreplicate a *Prices are pre-tax. patients anatomy inrevision knee arthroplasties. Industrial Design Style, 10A* ODEP rating for CR and PS knees both with and without 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). While designing the Persona Knee, we used a combination of advanced research tools to study hundreds of knees, creating a global bone atlas. 7i. 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. Contact National Injury Help today at 1-800-214-1010 for a free case evaluation to see if you qualify, or use the form on the right-hand side of your screen. With over 15 years and over 3 million implantations worldwide, Triathlon has a long clinical history. Beginning in March 2015, however, the FDA launched a class II recall of the uncemented version of the Zimmer Persona due to an increase in complaints of loosening and radiolucent lines. More than 11,600 units of the device were affected by the ongoing recall, many of which had already been implanted in patients. Please remove one or more studies before adding more. Before you decide, ask us to send you free written information about the qualifications and experience of our sponsoring firms. Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Could we be more bone conserving? The Zimmer-Biomet Persona Total Knee Cruciate-Retaining Femoral Component (CR Femur), used in conjunction with the kinematic alignment surgical technique, has been shown to produce better functional outcomes and improved patient satisfaction following total knee arthroplasty. Talk with your doctor and family members or friends about deciding to join a study. This field is for validation purposes and should be left unchanged. of Primary Total Knee Replacement with Hybrid Fixation. Patient outcomes can be driven by the precision and accuracy of each [TimeFrame:2 Years], Knee Prosthesis motion by means of Fluoroscopy. Anti Slip Coating UAE 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. patients arent fully satisfied with the feel of their new knee.1-3. Instrumentation Surgical Technique, Persona The Personalized Knee Clinical Summary, All content herein is protected by copyright, trademarks and other Only cemented femoral components will be used for this study. A total score is calculated ranging from -0.624 (worst) to 1 (best). Recruitment is expected completed after a period of 1.5 year. Tibia specs:Anatomic disproportional M/L growth, 9 sizes, left and Information provided by (Responsible Party): Anders Troelsen, Hvidovre University Hospital, Persona Total Knee System with MC polyethylene bearing. Open the catalog to page 1. Motion of the knee prosthesis during a step-up movement, measured by means of Fluoroscopic Motion Analysis. Combine these enhancements with a full continuum of bearing Those cookies that we do use are designed to permit you to use the site functions and browse our site in the way that is favorable to you. Femur specs:Anatomic design with21 distinct profilesin2mm Overnight delivery orders must be placed . Eventually parts wear out and need to be replaced, but it is estimated up to 85 percent of artificial knees still work after 20 years. Tapered Screw-Vent Implant System Product Catalog. You should expect your instruments 1961 May 27;1(7187):1129-32. doi: 10.1016/s0140-6736(61)92063-3. 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. Information provided by (Responsible Party): R.G.H.H. featuring personalized implants, precise instrumentation, and proven technology. research tools to study hundreds of knees. One design change that is introduced is the medial congruent (MC) polyethylene to be used instead of standard cruciate retaining (CR) design. Why? AAOS_Femur_AP_Diff_ChartReference based onZiBRAfemoral As a follow-up of the NexGen TKR, an improved design has recently been introduced by Zimmer: The Persona TKR (Zimmer, Warsaw, Indiana . Now its time to listen to his victim. Participant inclusion All participants will receive oral and written information about the project before consent. %%EOF Annually 40 TKA procedures are performed in our department, of which about 70% is Osteo Arthritis (OA) and 30% Reumatoid Arthritis (RA). assemble, so we created a matte finish. Trabecular MetalMaterial, Predecessor to the Persona System, the NexGen Knee System is the This study is designed as a single-blind randomized trial between the Persona PS total knee prosthesis and the well-established NexGen total knee prosthesis. When osteoarthritis occurs, the cartilage that cushions the bones of the knees softens and wears away, leaving the bones to rub against each other causing stiffness and pain. Restoreligament balance with fivelevels of constraint in 1 mm Geerdink CH, Grimm B, Vencken W, Heyligers IC, Tonino AJ. Only cemented tibial components will be used for this study. Different sample sizes are used for the different parts of this study: The study population will consist of patients with symptomatic osteoarthritis of the knee scheduled for TKR surgery at the Department of Orthopaedics, Leiden University Medical Center. 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 According to the agency's database, there were nearly 1,300 recalls on knee replacement systems or components between 2003 and 2019. This type of arthritis is caused by wear and tear on the joints and usually occurs in people over the age of 50. The secondary objective is to assess and compare clinical data, kinematics, prosthesis placement and patient reported outcome measures. matters. Zimmer Persona Surgical Technique (97-5026-001-00) for the Persona implant family. Revision surgeries to replace failed prosthetic knees are more complicated than initial surgeries and are not always as successful. BMJ. 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. The primary investigator of this project has independently initiated the project. to be accurate, but we didnt want to stop with just being precise. Pair it with ROSA Knee and the Personalized Alignment technique to deliver personalized patient care. However, currently no studies exist evaluating outcome following use of MC polyethylene bearing. decisions with each step and provide options for you to personalize Nelissen, Leiden University Medical Center: Device: Persona PS Knee Prosthesis by Zimmer, Device: NexGen PS Knee Prosthesis by Zimmer. In designing the Persona Knee, we identified several A class II recall means the probability of death or serious injury is remote but the use of the recalled device may cause temporary or reversible adverse health consequences. Epub 2008 Nov 22. While designing the Persona Knee, we used a combination of advanced 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. We do not use cookies for targeted or behavioral advertising on this website. to predictably improve patient satisfaction is to more closely Total knee replacement surgery is typically performed by an orthopedic surgeon, a doctor that specializes in diseases and injuries of the musculoskeletal system, which includes the bodys bones, muscles, cartilage, ligaments and joints. Statistics A professional statistical software package will be used when processing data in this project. 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. FAQs About Bravelle Is there a reimbursement lawsuit? 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. 2008 Oct;90(10):2160-70. doi: 10.2106/JBJS.G.00870. March 30, 2009. Zimmer Biomet Instrumentation To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Market Strategies International. Chronic, severe knee pain can be caused by many factors, the most common of which is arthritis. Prosthesis placement and bone resection measured by means of CT and caliper measurements of the resected bone parts. comprehensive femoral sizing scheme on the market. The Forgotten Joint Score (FJS) measures the degree of joint awareness. Nicoll, D. and PPTX. patient? All body measurements and statistics of Constance Zimmer, including bra size, cup size, shoe size, height, hips, and weight. The simple one-piece design allows for a single-stage protocol, saving time and resulting in less trauma to soft tissue, and less discomfort for your patients. Knee replacement lawsuits claim the devices loosened, became unstable and required revision surgery to correct the problems. General Health: EuroQol 5 Dimensional (EQ-5D) Health Questionnaire measured using patient questionnaire, Knee Function: Knee injury and Osteoarthritis Outcome Score (KOOS) measured using patient questionnaire, Pain score after activity and during rest; (Likert scale 0-10). It is ensured that the participant has understood the content of both the oral and written information before signed consent is given. No abstract available. Lancet. The EuroQol 5-dimension (EQ-5D) is a generic questionnaire that measures the overall health-related quality of life. Participants may be excluded intraoperatively if the PCL is found insufficient and LPS prosthesis is required. More than a thousand lawsuits were filed against Zimmer Inc. in recent years over its NexGen knee implant. In what steps would you like better information before proceeding? 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. Check the appropriate knee implant size matching chart for .. Data recording Data relevant for this project will be registered in a data sheet.