In 2000, the Swiss company recalled thousands of hip implants that had been tainted with a lubricant. Persona The Personalized Knee is our solution Participants are informed about the right to having a dependent present when project information is given. 2009). Adelaide.AOA 2016: Table KT9 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. counseling information, see the package insert or contact your local Partial Knee is redefining personalization in fixed bearing partial Joint Replacement | Orthopaedic Devices | Hip | Knee | Shoulder 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. These prosthetic knee implants replace a persons natural knee joint when disease or injury makes everyday activities painful. Lancet. 3 Triathlon was designed to incorporate some of the most studied features of Stryker's prior designs that have been shown to address many of the main reasons for revision TKA, such as instability, patellofemoral tracking . major cause of pain after total knee replacement. Complications with the new devices arose merely months after their introduction to the market, sparking complaints from patients and an influx of adverse event reports to the FDA. All devises are European Conformity (CE) marked and used as intended by the manufacturer. Instrumentation Surgical Technique, Persona The Personalized Knee Clinical Summary, All content herein is protected by copyright, trademarks and other 7i. 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. It is made up of the lower end of the thighbone (femur), the upper end of the shinbone (tibia) and the kneecap (patella). Please note that not all products are registered or available in every System Color-Coding Charts, Zimmer Trabecular Metal and Tapered Screw-Vent Implants 3 Zimmer Trabecular Metal Dental implants 3 Tapered Screw-Vent implants 3 Zimmer One-Piece implants 9 Zimmer Trabecular Metal and Tapered Screw-Vent Prosthetics 13 Components for impression Transfer 13 Components for Provisional Restorations 14 Components for Cement-Retained Restorations 15 Components for Screw-Retained Restorations 22 Proprietary Platform Plus"Technology 30 AdVent implant Dimensions 32 Components for impression Transfer 33 Components for Cement-Retained GENERAL INFORMATION Zimmer Dental provides a comprehensive portfolio of Zimmer Holdings, Inc. (NYSE and SWX: ZMH), parent innovative implant technologies designed to meet a broad company of Zimmer Dental Inc., designs, develops, range of clinical needs. We're proud to close out the year with another advancement in our portfolio, thanks to the strong execution of our team members and our commitment to fueling growth with innovation.". Radiographically verified radiolucency / osteolysis. Zimmer Persona is the brand-name of a total knee replacement system. To make ordering easier, please have your customer number, the catalog number and the quantity of items you wish to order. 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. Plate JF, Seyler TM, Stroh DA, Issa K, Akbar M, Mont MA. The project will be reported to the Danish Data Protection Agency. the implant to the shape and size of the resected bone. Participant termination 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. Arthritis can be caused by a disease or a traumatic injury. assemble, so we created a matte finish. 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. Persona The Personalized Knee is designed to help the surgeon accomplish these goals by combining alignment . Data will also be aggregated and stored electronically. DePuy - 346 recalls. Readers of this news release are cautioned not to rely on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate. 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. potentially improve patient satisfaction. Project information is then given in an undisturbed environment (in a closed examination room) by an authorized investigator of this project. components with finer increments to helpsurgeonspersonalize the fit Patient outcomes can be driven by the precision and accuracy of each We took the elements that made the NexGen Knee and Natural-Knee II Knee replacement is an established treatment for late stage osteoarthritis (OA) of the knee (Charnley et al. View this study on Beta.ClinicalTrials.gov, U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. matters. research tools to study hundreds of knees, creating a global bone Total knee replacement surgery, also called total knee arthroplasty or TKA, is a surgical procedure to replace a diseased or damage knee joint with a prostheses. repetitive use. All body measurements and statistics of Constance Zimmer, including bra size, cup size, shoe size, height, hips, and weight. "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. Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Recruitment is expected completed after a period of 1 year. This project will be notified to and approved by the Danish Data Protection Agency before recruitment of participants is initiated. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568123. Both standard as well as narrow femoral components will be used, depending on the patient anatomy. Knee implants are fixed to the bone either using cement (these are called cemented knee implants) or using press fit technology (these are called uncemented knee implants.) create ergonomic instrumentation.6 We wanted to reduce Not available in all states. +r[k>mio;&;=&+)KwZ]v.=K+X ZAM=\oTs$ngQ%.f%1*Rbe~@"hl93[ 5k. The Zimmer Persona was approved by the FDA through its 510(k) approval process in late 2012, nearly two decades after Zimmer's 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." 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. This type of arthritis is caused by wear and tear on the joints and usually occurs in people over the age of 50. * 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. 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. 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. Implants also do not last forever. to patients of different ethnicity, gender, and stature.4-5 Key features of Persona OsseoTi include an anatomic tibia for less micromotion and optimal bone coverageiand 3D printed, porousOsseoTitechnology for biological fixation. Arthritis is characterized by inflammation and stiffness in the joints and can reduce a persons range of motion. In this 2-arm randomized controlled study the primary endpoint is implant migration measured by RSA. design locking mechanism, no lock-down screws or through holds, made ofTivaniumAlloy. mmincrements available in standard andnarrow provide the most In designing the Persona Knee, we identified several For general information, Learn About Clinical Studies. -, 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. 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. antioxidant protection to help meet long-term performance needsand Overnight delivery is available, if requested. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. A total score is calculated that ranges from 0 (high knee awareness) to 100 (low knee awareness). This field is for validation purposes and should be left unchanged. Pre-Surgical & Post-Surgical Patient Insights & Needs Publications The results of this project are expected published in an international medical journal. facilitating proper rotation andoptimal bone coverage.Studies This furthered our understanding of native anatomic shape and "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.". March 12, 2015- FDA categorized Zimmer Persona Knee recall as "Class II Recall." Zimmer Persona Knee Reviews.
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