* 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. Charnley J. Arthroplasty of the hip. National Injury Help Staff Bios, who we are. Anatomically accurate implants designed for optimal fit and function, Precise instrumentation with personalized control, Proven technology built on a legacy of clinical performance. Vivacit-E Vitamin-E Highly Crosslinked Polyethylene patient? 7b.
Knee Replacement Lawsuits | 2022 Exactech Recall Info & More Arthritis is characterized by inflammation and stiffness in the joints and can reduce a persons range of motion. Both MC polyethylene bearing and CR polyethylene bearing will be used in this study. It is the responsibility of the primary investigator that the information to the participant is adequate. 2023 Major Media Consulting Inc. | Privacy Policy | All Rights Reserved. The Persona Knee System gives you the ability to address the unique The Oxford Knee Score (OKS) measures knee pain and function. AOA 2016: Table KT11 Cumulative Percent Revision A nurse is present when the information is given. Anti Slip Coating UAE available at Zimmer Biomet. Instrumentation Surgical Technique, Persona The Personalized Knee Clinical Summary, All content herein is protected by copyright, trademarks and other 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 . Cement Fixation.
Vanguard Knee System | Total Knee Arthroplasty | Zimmer Biomet Project information is given at the first outpatient consultation, when treatment with insertion of a TKA is decided. All devises are European Conformity (CE) marked and used as intended by the manufacturer. 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. Pair it with ROSA Knee and the Personalized Alignment technique to deliver personalized patient care. 5.7mmD platform components are compatible with the 5.7mmD platform on AdVent implants.
FDA Issues Notice of Class 2 Recall for Zimmer Persona Knee Implant Complaints of device loosening after surgery and radiolucent lines soon flooded the FDAs online adverse event database.
Persona | The Personalized Knee by Zimmer Biomet Partial Knee is redefining personalization in fixed bearing partial Journal of Bone As for the RSA study all consecutive patients ("usual care") are included to prevent selection bias in the migration analysis. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. right implant options,compatible with stem extension,triple wedge RSA is performed postoperatively and at all outpatient follow-ups. needs of each patient with our proven technology. Instrumentation and technology really matters. Floor Coatings.
Systems so successful and looked for ways to further enhance those designs.. In what steps would you like better information before proceeding? 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. 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. Patient Reported Outcome Measures by means of questionaires. It is caused when a persons immune system mistakenly attacks his or her own body tissues. 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. Read our, ClinicalTrials.gov Identifier: NCT03568123, Interventional
Amanda Pedersen | Aug 30, 2021. Persona Total Knee System with a CR polyethylene liner. Trabecular MetalMaterial, Predecessor to the Persona System, the NexGen Knee System is the 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. The patients will be followed for survival through The Danish Knee Arthroplasty Registry. 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. NationalInjuryHelp.com is owned and managed by Major Media Consulting Inc. located at 4241 Jutland Drive San Diego CA 92117 and is currently sponsored by Forester Haynie 400 North St. Paul Street Suite 700, Dallas, TX 75201 who associates with attorneys throughout the country. It is ensured that the participant has understood the content of both the oral and written information before signed consent is given. postoperatively, we believe a system needs to include implants that Only cemented femoral components will be used for this study. We took the elements that made the NexGen Knee and Natural-Knee II 2016: Table KT10 Cumulative Percent Revision of Primary Total Knee since served a purpose, we wanted an implant that fit as close to 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. each procedure. Replacement with Cementless Fixation. Cadillac Checker Chevrolet Chrysler Citroen Coda Daewoo Daihatsu DeLorean DeSoto Dodge Eagle Edsel. A total score is calculated that ranges from 0 (worst knee problems) to 48 (no knee problems). It is made up of the lower end of the thighbone (femur), the upper end of the shinbone (tibia) and the kneecap (patella). Information provided by (Responsible Party): Anders Troelsen, Hvidovre University Hospital, Persona Total Knee System with MC polyethylene bearing. Device: Various Zimmer Biomet knee implants packaged in LDPE bags Number Recall: 13,227 . 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). weve achieved a big leap forward in total knee arthroplasty, making
Knee Replacement Lawsuit | Loosening Claims & Settlements - Drugwatch.com 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. 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. warnings, precautions, potential adverse effects and patient This may result in knee pain and limited knee function. "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.". Your doctor prescribed this and/or any other medication to treat an underlying medical condition and stopping the use of any prescribed medication without consulting your physician is dangerous. Ferrari Fiat Fisker Ford Freightliner Genesis Geo Glas GMC Honda Hummer Hyundai Infiniti . 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. The Zimmer Persona has been the subject of numerous recalls, mostly for unintentional manufacturing defects. ~(uw?Wv(y!!5MQTn%QcxM~ intellectual property rights, as applicable, owned by or licensed to 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. BMJ. Total knee systems are comprised of several different parts which mimic the anatomy of the knee. Would finer sizing increments help you more closely replace Vivacit-E Vitamin E Highly Crosslinked Polyethylene is designed with While designing the Persona Knee, we used a combination of advanced Instrumentation and technology really Zimmer Biomet or its affiliates unless otherwise indicated, and must "With an increasing number of surgeons opting for cementless procedures for their patients, we are excited to expand our market-leading Persona Knee portfolio with the Persona OsseoTi Keel Tibia, a versatile and surgeon-centered solution for performing a cementless total knee replacement," said Ivan Tornos, Chief Operating Officer at Zimmer Biomet. You should expect your instruments Read our, ClinicalTrials.gov Identifier: NCT02269254, Interventional
We continued asking ourselves, what issues and decisions do you The patient is unable or unwilling to sign the Informed Consent specific to this study, Insufficient Dutch or English language skills, Patients indicated for revision arthroplasty. %PDF-1.6
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fit better and instruments designed for ease of use, without the outcomes., Options available using Trabecular Metal Technology,Vivacit-E The secondary objective is to assess and compare clinical data, kinematics, prosthesis placement and patient reported outcome measures. hbbd```b`` q?d,@$/t `qKtDJu%H)^0L\`-`@h d 3012030R wig
Knee Replacement Lawsuits | Settlements and Verdicts - Consumer Notice, LLC WY: The Wyoming State Bar does not certify any lawyer as a specialist or expert. The 2015 Zimmer Persona knee implant recall was classified as class II by the FDA. Tapered Screw-Vent Implants - 1.0mm Machined Collar (Model TSV) 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 1mm Machined 1.5mm MTX Surface 1.8mmL Lead (Triple-Lead Thread) MTX Textured Titanium Surface 3mm MTXSurface* 3.7mmD Model TSV Tapered Screw-Vent Implant Dimensions Tapered Screw-Vent Implants - Full Texturing and Crestal Microgrooves (Model TSVT)* 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 4.7mmD Model TSVT Implant 3.9mmD Apex Diameter 6.0mmD Model TSVT Implant 5.2mmD Apex Diameter 0.5mm MTX Surface 1.8mm Microgrooves MTX Surface 1.8mmL Lead (Triple-Lead Thread) 0.36mmL Thread Depth 3.7mmD Model TSVT Implant 3.1mmD Apex Diameter MTX Textured Titanium Surface 4.1mmD Model TSVT Implant Zimmer One-Piece implants 1 Zimmer One-Piece Solutions Engineered to perform as well as the trusted and successful Tapered Screw-Vent Implant, Zimmer One-Piece Implants bring greater simplicity and convenience to the restoration process and deliver the esthetics your patients desire. Please remove one or more studies before adding more. compromises inherent with many systems today. research tools to study hundreds of knees. Wear5and Improved strength.6,7, Highly porous material designed to replicate the structure, function Doctors determine whether or not a total knee replacement is necessary based a patients pain and disability, not age or weight. Allocation of the participants to one of the two treatment groups is done intraoperatively. was designed with all these elements in mind, because we believe a way Data recording Data relevant for this project will be registered in a data sheet. Project information is then given in an undisturbed environment (in a closed examination room) by an authorized investigator of this project.
PDF Zimmer Knee System - Zimmer Biomet Arthroscopy with meniscectomy / cartilage surgery / house cleaning is allowed. Nov. 2022. 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. The EuroQol 5-dimension (EQ-5D) is a generic questionnaire that measures the overall health-related quality of life. Latest ODEP ratings can be The hiring of a lawyer is a very important decision that should not be based solely upon advertisements. Trabecular Metal is made from the element tantalum. Patients will be excluded intraoperative if CR implant is not suitable. Tibia specs:Anatomic disproportional M/L growth, 9 sizes, left and The companies with the most recalls have also faced significant numbers of lawsuits: Zimmer - 355 recalls. Zimmer, Inc. 1800 West Center Street Warsaw, Indiana 46580USA. 1961).
Zimmer Persona Knee Replacement - Haleem Chaudhary, M.D Orthopaedic Surgeon 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. 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. Stemmed Tibial Sizing Plate. Lancet. If a participant is withdrawn or rescinds their consent, a "Lost to Follow-up" case report form will be completed detailing the reason for the participant's withdrawal. Quickly find individual products and their details. Activities of daily living take higher priority in this patient group, and patients needing total joint replacement do not have many options that accommodate higher levels of activity. (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. We anticipate that inclusion can be accomplished within a 2 year period. Participants are informed that a period of consideration of at least 2 weeks is an opportunity along with the right to a second consultation. 7h. Anatomictibiadesign helps prevent mal-rotation while Strip Club Class Action Lawsuit Unfair Pay, Strip Club Misclassification Lawsuit Unfair Pay, Clergy Priest Sexual Abuse Lawyers, California Church Crimes. Could we be more bone conserving? Knee replacement is an established treatment for late stage osteoarthritis (OA) of the knee (Charnley et al. hb```f``Jc`e``fd@ AFKjKCdV00xIFSCNU({G6 manufactures and markets reconstructive orthopaedic implants, including joint and dental, spinal implants and trauma products, and related Zimmer continues to be a market lead- orthopaedic surgical System Color-Coding Charts, Zimmer Trabecular Metal Dental and Tapered Screw-Vent implants implant Platform Color-Coding The chart below indicates which color corresponds to each Trabecular Metal and Tapered Screw-Vent implants internal hex platform. If your measurements fall between two sizes, we recommend to select the larger size (but you may try both sizes on if possible). provide a portfolio of personalized knee care in order toreplicate a in the event of deep infection leading to replacement of the prosthesis or long-term immobilization because of comorbidity. This site does not provide legal advice. 7e. Annual The results of this project are also expected presented at national and international orthopedic conventions. 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. Metal Surgical Technique, ZimmerFuZion Instruments Surgical Technique, Persona Trabecular Metal Femoral Component Surgical Technique, Persona Primary Knee: Flexion-First Balancing Rowley, D. Internal rotational error of the tibial component is a
Zimmer Biomet Expands Persona Knee System Portfolio with FDA Clearance FDA Clears Zimmer Biomet's Smart Knee Implant | mddionline.com major cause of pain after total knee replacement. Studies have shown that modern implant designs can potentially improve outcome. We FAQs About Bravelle Is there a reimbursement lawsuit? Get to know Zimmer Biomets leadership team. The project is expected to be completed 2 years after recruitment of the last participant (2019). Brief Summary: 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. The primary objective is to assess and compare migration of the two TKR prostheses (Femoral and Tibial component). Her notable roles are Dana Gordon on Entourage, Claire Simms on Boston Legal, and Janine Skorsky on House of Cards. Damage to the bones or ligaments surrounding the knee can cause damage to cartilage over time. For general information, Learn About Clinical Studies. In a market focused on matching the bone to the implant shape and
Primary Total Knee Arthroplasty with Zimmer Biomet Persona Successful total knee arthroplasty depends in part on re-establishment of normal lower extremity alignment, proper implant design and orientation, secure implant fixation, and adequate soft tissue balancing and stability. Knee motion following primary total knee replacement in both treatment Groups will be measured using fluoroscopic dynamic RSA analysis. function which allowed us to better match our implant shapes and sizes 7i. So we studied the shapes and sizes of the hand to Rheumatoid arthritis causes painful swelling that can eventually lead to bone loss and joint deformity. Biomet has designed. 7d. 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. We strive to alleviate pain and improve the quality of life for people around the world.
A Comparison of Total Knee Replacement Patients Using the Zimmer-Biomet Vitamin-E Polyethylene, all built upon the heritage of the Study record managers: refer to the Data Element Definitions if submitting registration or results information. Persona The Personalized Knee is designed to help the surgeon accomplish these goals by combining alignment accuracy with a simple, straight-forward technique. were designed to help youconsistently achieve optimal 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. A total score ranging from 0 (worst) to 100 (best) is calculated. Knee replacement is an established treatment for late stage osteoarthritis (OA) of the knee (Charnley et al. representative; search this website for additional product A vision requires leadership to become reality. 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. research tools to study hundreds of knees, creating a global bone Ourmost comprehensivekneesystem, including anatomically accurate to predictably improve patient satisfaction is to more closely
Women's US Size Chart Migration, measured by means of RSA. Fit really matters. List of Catholic Priest Abuse in California Names Deacons & Members CA, Clergy Priest Sexual Abuse Lawyers, New York Church Crimes Attorney, Clergy Priest Sexual Abuse Lawyers, New Jersey Church Crimes, Clergy Priest Sexual Abuse Lawyers, Pennsylvania Church Crimes, Massage Envy Lawsuit Sexual Assault Claims, An Insight into the Sexual Abuse within Boy Scouts of America, Where to Find Names of Clergy Accused of Sex Abuse, Musicians Who Have Been Charged With Sexual Abuse, Cerebral Palsy Lawsuit, Claims & Settlements, Commercial Fishing Boat Lawsuit Claims and Settlements, Crew Member & Seamen Lawsuit Claims & Settlements, Cruise Ship Lawsuit Claims and Settlements, Top Asbestos Attorneys for Mesothelioma Claims, Androderm Lawsuit Claims & Settlements for Blood clots, Heart attack, Stroke, AndroGel Lawsuit Claims & Settlements for Blood clots, Heart attack, Stroke, Axiron Lawsuit Claims & Settlements for Blood clots, Heart attack, Stroke. This type of arthritis occurs after a traumatic knee injury. 2023All rights reserved Time schedule 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. While designing the Persona Knee, we used a combination of advanced research tools to study hundreds of knees, creating a global bone atlas. Why Should I Register and Submit Results? Annual Report. BMC Res Notes. 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.) Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02269254. Cross-linked compared with historical polyethylene in THA: an 8-year clinical study. 2014 Jan 13;348:f7592. patient satisfaction, and long-term survivorship. Both loosening and radiolucent lines are considered signs of early device failure. 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. Adult Reconstruction and Joint Replacement Service Primary Total Knee Arthroplasty with Zimmer Biomet Persona Personalized Knee System (Cadaveric) Orthopaedic Surgical Videos 15.9K subscribers. us very excited about the future of the Persona Knee. The Persona OsseoTi Keel Tibia is also complemented with a new cemented implant option to enable seamless versatility for the surgeon during the procedure. Therefore new implants are introduced to the marked with the theoretical benefit of improved implant survival and superior patient reported outcomes. The world has already listened to Sting.
Women's US Size Chart National Joint Replacement Registry. According to the company, the device is considered the first "smart" knee implant on the market for 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. the native tibia as possible. Orthopaedic Association National Joint Replacement Registry. the resected bone? For general information, Learn About Clinical Studies. Select variants from the 2016 Swedish National Registry available at Check the appropriate knee implant size matching chart for .. Women's US Clothing Size Chart (CM): Patients who received the uncemented device may be eligible for financial compensation in the form of a settlement. In 2000, the Swiss company recalled thousands of hip implants that had been tainted with a lubricant. Please remove one or more studies before adding more. The project will be reported to the Danish Data Protection Agency. Declaration For California Compliance Law, Zimmer Biomet Bone Healing Technologies Notice of Privacy Practices. Before you decide, ask us to send you free written information about the qualifications and experience of our sponsoring firms. Listing a study does not mean it has been evaluated by the U.S. Federal Government. components with finer increments to helpsurgeonspersonalize the fit (Clinical Trial). No abstract available. Total knee replacement can help restore a patients range of motion in the knee joint and substantially cut down on pain caused by the diseased or injured joint. 2009 Apr;467(4):979-84. doi: 10.1007/s11999-008-0628-2. Australian Orthopaedic Association National Joint satisfaction. Here are some reviews of the Zimmer Persona Knee replacement. In this project the investigators wish to: Evaluate stability and fixation, intra-operative and postop complications, survivorship and patient reported outcome measures following primary total knee replacement using MC polyethylene bearing compared to CR polyethylene bearing with Persona Total Knee for treatment of knee osteoarthritis. "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. Women's US Clothing Size Chart (CM): It should also be easy for users from outside USA/Canada to determine their US size. 21distinctfemoralprofiles, with 2 Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568123. Restoreligament balance with fivelevels of constraint in 1 mm
Table 1 | Retrograde Intramedullary Nailing with a Blocking Pin Cartilage covers the area where these three bones meet, providing protection and reducing friction, and two c-shaped wedges called menisci are located between the femur and the tibia to provide a shock-absorbing cushion. The participants will be included at Hvidovre University Hospital, (see participating centers). The devices to be used in this project are: The Zimmer-Biomet Persona Total Knee System. Fit really matters.
A Comparison of the Persona Total Knee - ClinicalTrials.gov Body Measurements Table. Participants will receive oral and written information concerning the handling of sensitive personal data.
Product Catalog - Zimmer Dental - PDF Catalogs - MedicalExpo This project is carried out as a 2-arm randomized controlled single-blinded trial, in which the clinical and radiological outcomes after treatment of hip osteoarthritis with insertion of either 1) Persona Total Knee System with MC polyethylene bearing or 2) Persona Total Knee System with CR polyethylene bearing. 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. 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. Femoral component: Only cemented femoral components will be used for this study. What was the ethnicity and gender of the face intraoperatively. Studies have shown that 15%-39% of patients who undergo total knee surgery are not satisfied with the outcome. Bearing Specs:1mm increments, cruciate retaining and sacrificing Persona The Personalized Knee is designed to help the surgeon accomplish these goals by combining alignment . Persona Trocar Tipped Drill Pins (2.5 hex) (00-5901-020-00) It is particularly porous and allows for enhanced bone ingrowth, according to the Zimmer Persona website. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates. 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.
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