These options found within the Persona Knee Systems March 12, 2015- FDA categorized Zimmer Persona Knee recall as "Class II Recall." Zimmer Persona Knee Reviews. Overnight delivery is available, if requested. 2009). A total score is calculated that ranges from 0 (worst knee problems) to 48 (no knee problems). hbbd```b`` q?d,@$/t `qKtDJu%H)^0L\`-`@h d 3012030R wig A total score is calculated that ranges from 0 (high knee awareness) to 100 (low knee awareness). The research assistant handling both standard RSA as well as dynamic RSA analysis is also unaware of which prosthesis the participant has received. Device: Various Zimmer Biomet knee implants packaged in LDPE bags Number Recall: 13,227 . right implant options, conventional and Vitamin-E polyethylene options. NexGen. A/P sizes. percent of painfulTotal Knee Arthroplasty (TKA) mind, because we believe a way to predictably improve patient *Prices are pre-tax. Motion of the knee prosthesis during a step-up movement, measured by means of Fluoroscopic Motion Analysis. The Vanguard Knee System offers an entire spectrum of knee stability, including: Two femoral stabilization options: cruciate retaining (CR) and posterior stabilized (PS) Ten femoral sizes Nine tibial sizes Five levels of bearing constraint Complete interchangeability between femoral and tibial components Only cemented femoral components will be used for this study. In a market focused on matching the bone to the implant shape and In the largest knee replacement lawsuit settlement, Sulzer Medica paid $1 billion to settle 4,000 hip and knee implant cases. 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. 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. 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. 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. FAQs About Bravelle Is there a reimbursement lawsuit? Non-transparent envelopes are used for the randomization process. Prices do not include applicable sales tax or shipping costs. Stratification is performed per diagnosis group (OA/RA). 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. to deliver personalized patient care. With over 15 years and over 3 million implantations worldwide, Triathlon has a long clinical history. Zimmer Biomet- ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 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. A nurse is present when the information is given. Arthritis can be caused by a disease or a traumatic injury. (Clinical Trial), Migration and Kinematics of the New Persona PS Versus the Proven NexGen LPS Knee - a Randomized Controlled Trial Using Radiostereometric Analysis and Fluoroscopy, 21 Years to 90 Years (Adult, Older Adult), Dep. In case only one of the bones has insufficient markers, the patient will be followed for the other bone. 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. If your measurements fall between two sizes, we recommend to select the larger size (but you may try both sizes on if possible). a NexGen knee, 1 in 5 knees implanted Before you decide, ask us to send you free written information about the qualifications and experience of our sponsoring firms. "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. Fit really matters. Patients will be excluded intraoperative if CR implant is not suitable. See our US Plus Size Chart. A vision requires leadership to become reality. Both standard as well as narrow femoral components will be used, depending on the patient anatomy. 2 Femur Exposure SECTION2 . Complications of the Zimmer Persona as reported by patients and their doctors include: When the Zimmer Persona knee replacement system was introduced to the market, it was extolled by its manufacturer as the most anatomically accurate knee implant ever made. Project information is given at the first outpatient consultation, when treatment with insertion of a TKA is decided. 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. Bust. Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. A total score is calculated ranging from -0.624 (worst) to 1 (best). We took the elements that made the NexGen Knee and Natural-Knee II Persona The Personalized Knee is designed to help the surgeon accomplish these goals by combining alignment . Market Strategies International. That is why we also give you Women's General Size Chart with measurements in CM. However, currently no studies exist evaluating outcome following use of MC polyethylene bearing. Anyone considering a lawyer should not rely upon advertisements or self-proclaimed expertise, and independently investigate the lawyer's credentials and ability. 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. r implant implant Diameter Platform Trabecular Metal Dental implant, MTX Surface, Fully Textured with Microgrooves Tapered Screw-Vent implants includes Fixture Mount/Transfer and Cover Screw. most widely used and clinically proven total knee system in the In what steps would you like better information before proceeding? Report. Specifications and prices are subject to change without notification. atlas. What was the ethnicity and gender of the 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. wanted you to have instruments that feel good in your hand after Adverse Events including intraoperative complications and revisions at any post-operative time points. Women's US Clothing Size Chart (CM): It should also be easy for users from outside USA/Canada to determine their US size. 1961 May 27;1(7187):1129-32. doi: 10.1016/s0140-6736(61)92063-3. 2009 Apr;467(4):979-84. doi: 10.1007/s11999-008-0628-2. In 2000, the Swiss company recalled thousands of hip implants that had been tainted with a lubricant. Arthroscopy with meniscectomy / cartilage surgery / house cleaning is allowed. Doctors determine whether or not a total knee replacement is necessary based a patients pain and disability, not age or weight. While you can expect excellent implant survivorship with many of These options Read our, ClinicalTrials.gov Identifier: NCT03568123, Interventional Annual Report. satisfaction is to more closely reproduce the original.. Secondary outcomes are: Oxford Knee Score (OKS), Oxford Knee Score -Activity & Participation Questionnaire (APQ), anchoring questions, EQ-5D, Forgotten Joint Score and knee motion measured using dynamic RSA. antioxidant protection to help meet long-term performance needsand System, created the foundation for what would become the Persona Knee. A new operation. capabilities and philosophies, precise in itsmeasurements, All devises are European Conformity (CE) marked and used as intended by the manufacturer. 21distinctfemoralprofiles, with 2 Joint Replacement | Orthopaedic Devices | Hip | Knee | Shoulder postoperatively, we believe a system needs to include implants that All sensitive personal data regarding participants will be stored in accordance with guidelines presented by the Personal Data Act. You have reached the maximum number of saved studies (100). 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. Chronic, severe knee pain can be caused by many factors, the most common of which is arthritis. Knee replacement lawsuits claim the devices loosened, became unstable and required revision surgery to correct the problems. By asking these kinds of questions, we were able to design It is made up of the lower end of the thighbone (femur), the upper end of the shinbone (tibia) and the kneecap (patella). Project design Project type 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. 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. A total score ranging from 0 (worst) to 100 (best) is calculated. Surgeons have been performing total knee replacements since the late 1960s. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Femoral component: Only cemented femoral components will be used for this study. 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). for each patient and restore the unique identity of every knee anatomy. Why Should I Register and Submit Results? Rowley, D. Internal rotational error of the tibial component is a The project is expected to be completed 2 years after recruitment of the last participant (2019). Could we be more bone conserving? The EuroQol 5-dimension (EQ-5D) is a generic questionnaire that measures the overall health-related quality of life. research tools to study hundreds of knees, creating a global bone [TimeFrame:2 Years], Knee Prosthesis motion by means of Fluoroscopy. 1961). The participants will be included at Hvidovre University Hospital, (see participating centers). Ourmost comprehensivekneesystem, including anatomically accurate 7b. Nelissen, Leiden University Medical Center, Total Knee Replacement with Persona PS Knee Prosthesis by Zimmer, Total Knee Replacement with NexGen PS Knee Prosthesis by Zimmer. This cautionary statement is applicable to all forward-looking statements contained in this news release. 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. A total of 60 participants are to be included at Hvidovre University Hospital. These lawsuits have been consolidated in a multidistrict litigation (MDL) in federal court. 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. 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. J Bone Joint Surg Am. No abstract available. Recruitment is expected completed after a period of 1 year. us very excited about the future of the Persona Knee. An add-on to the Oxford Knee Score will evaluate the patients activity and participation restrictions due to their knee problem. AAOS_Femur_AP_Diff_ChartReference based onZiBRAfemoral 2023 Major Media Consulting Inc. | Privacy Policy | All Rights Reserved. The lines between traditional medtech and digital healthcare continue to blur, and a perfect example of this trend is Zimmer Biomet's Persona IQ smart knee implant, which is now FDA cleared. Now patients many of whom still have the recalled device implanted are filing lawsuits against the devices manufacturer. In designing the Persona Knee, we identified several Both standard as well as narrow femoral components will be used, depending on the patient anatomy. This may result in knee pain and limited knee function. size, we found that the opposite needed to happen we need to match They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. National Injury Help Staff Bios, who we are. , This material is intended for health care professionals. RSA is performed postoperatively and at all outpatient follow-ups. The settlement averaged $200,000 per patient. hb```f``Jc`e``fd@ AFKjKCdV00xIFSCNU({G6 patient satisfaction, and long-term survivorship. Participants are informed that a period of consideration of at least 2 weeks is an opportunity along with the right to a second consultation. Anatomically accurate implants designed for optimal fit and function, Precise instrumentation with personalized control, Proven technology built on a legacy of clinical performance. There have been individual cohort studies, indirect comparisons and retrospective studies to test the efficacy of a variety of different total knee replacement devices but there are very few high quality investigations of new paradigms or significant design change. face intraoperatively. Annual Her notable roles are Dana Gordon on Entourage, Claire Simms on Boston Legal, and Janine Skorsky on House of Cards. In doing so, we confirmed Would finer sizing increments help you more closely replace 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.. Zimmer One-Piece implants feature: One-piece construction, eliminating micromovement and maximizing strength An integral, pre-contoured abutment, Zimmer One-Piece Implant Dimensions Zimmer One-Piece Implants 3.5mmD Emergence Profile with External Driving Flats 5.75mm Buccal/Labial Abutment Height 1.2mm Cuff Height 4.25mm Lingual Abutment Height 0.5mm Machined 1.2mmLLead (Triple-Lead Thread) MTX Textured Titanium surface 3.0mmD Zimmer One-Piece Implant (Straight Shown) 2.4mmD Apex Diameter. 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. Persona Instrumentation was designed to be versatilein its in the event of deep infection leading to replacement of the prosthesis or long-term immobilization because of comorbidity. This is a type of inflammatory arthritis that occurs when the protective lining of the knee joint, called the synovial membrane, becomes thickened and inflamed. While designing the Persona Knee, we used a combination of advanced research tools to study hundreds of knees, creating a global bone atlas. Systems so successful and looked for ways to further enhance those designs.. intraoperative glare from the instruments and make them easier to Altered pain perception and / or neurologic affection due to diabetes or other disorders. Cup with Spacers, 49 mm. 2014). 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. Cement Fixation. This project is financed by Zimmer-Biomet, Warsaw, Indiana, USA. Migration, measured by means of RSA. It is particularly porous and allows for enhanced bone ingrowth, according to the Zimmer Persona website. National Joint Replacement Registry. -, 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. Many knee implant manufacturers make personalized knee systems for women because of this and other differences. In spite of these high success rates, complaints of early device failure regarding the Zimmer Persona knee replacement system began to pour into the Food and Drug Administration soon after the device was marketed. All knees are performed in a standardized fast-track setup with the same surgical technique as described below, immediate mobilization after surgery and clinical and radiological controls after 3 months, 1 and 2 years. Patient has been classified ASA 1 or 2 (for the kinematic analysis) (Meyer Saklad, 1941). View this study on Beta.ClinicalTrials.gov. 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. Femur specs:Anatomic design with21 distinct profilesin2mm US Size. 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. Congruent Bearing is the most kinematic-friendly bearing Zimmer Components are available in numerous designs for both systems, with cemented as well as cementless fixations and with numerous polyethylene inserts to accommodate the surgical demand based on patient characteristics. ~(uw?Wv(y!!5MQTn%QcxM~ 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. One design change that is introduced is the medial congruent (MC) polyethylene to be used instead of standard cruciate retaining (CR) design. Participants will receive oral and written information concerning the handling of sensitive personal data. 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. Our legacy continues to come to life today through our progressive culture of evolution and innovation. The storage of data will be done according to the rules posted by the Danish Data Protection Agency. 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). Persona Total Knee System with a CR polyethylene liner. Zimmer Biomet isaglobal medical technology leader with a comprehensive portfolio designed to maximize mobility and improve health. 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. Publications The results of this project are expected published in an international medical journal. The Persona Knee System gives you the ability to address the unique 2014 Jan 13;348:f7592. These complications can include infection and blood clots. The 2015 Zimmer Persona knee implant recall was classified as class II by the FDA. facilitating proper rotation andoptimal bone coverage.Studies Implants also do not last forever. Comparative statistics will be used based on the distribution of data. 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. 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. Tibia specs:Anatomic disproportional M/L growth, 9 sizes, left and Adelaide.AOA Did you have to sacrifice stability for fit? Persona the Personalized Knee Surgical Technique - Zimmer Biomet Statistics A professional statistical software package will be used when processing data in this project. One design change that is introduced is the medial congruent (MC) polyethylene to be used instead of standard cruciate retaining (CR) design. A plastic spacer is then inserted between the two metal components to create a smooth, frictionless surface. doi: 10.1136/bmj.f7592. assemble, so we created a matte finish. Zimmer Persona Trabecular Metal Tibial Plate / Persona TM Tibia Number Recall: 11,658 Reason: Increase in complaints of radiolucent lines and loosening. The Zimmer Persona femoral and tibial components are made from Zimmers patented Trabecular Metal technology. Catalog Number: 8065-546-32 All Lot numbers. The manufacturer, Zimmer, says its recall is voluntary. This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Size of the component: Intercondylar width of the component (mm) Distance from the anterior femoral osteotomy phase to the open box anterior edge of the component (mm) Senko Medical (Tokyo, Japan) Quest CR: 1-5: 15-18.6: 18.9-24.7: Smith & Nephew (Memphis, TN) Genesis II CR: 1-8: 16.5-19: 16-19.9 Genesis II PS: 1-6: 16.5: 11-23 function which allowed us to better match our implant shapes and sizes Co-authorship is awarded according to the Vancouver rules. We also believed that the femoral shape should reflect In doing so, we confirmed that implant shape really matters. Overnight delivery orders must be placed by 4:00 p.m. PST. If the minimally relevant total migration of the prosthesis measured by RSA is set to 0.2 mm then a total of 18 participants must be enrolled in each study group to show a statistically significant difference (95 % confidence, 80 % power). Participants are informed about the right to having a dependent present when project information is given. Overnight delivery is available, if requested. Wear5and Improved strength.6,7, Highly porous material designed to replicate the structure, function For general information, Learn About Clinical Studies. +r[k>mio;&;=&+)KwZ]v.=K+X ZAM=\oTs$ngQ%.f%1*Rbe~@"hl93[ 5k. Project information is then given in an undisturbed environment (in a closed examination room) by an authorized investigator of this project. 409 0 obj <>/Filter/FlateDecode/ID[<4CFFF6002367B97D87B78669E948DEE2><9397F989D1D57E479435879AAB8D2EDD>]/Index[384 41]/Info 383 0 R/Length 119/Prev 680799/Root 385 0 R/Size 425/Type/XRef/W[1 3 1]>>stream WY: The Wyoming State Bar does not certify any lawyer as a specialist or expert.