Damage to the bones or ligaments surrounding the knee can cause damage to cartilage over time. The specific component involved in the recall was called a Trabecular Metal Tibial Plate. step within the surgical procedure. While designing the Persona Knee, we used a combination of advanced Quickly find individual products and their details. The 2015 Zimmer Persona knee implant recall was classified as class II by the FDA. right implant options,compatible with stem extension,triple wedge With over 15 years and over 3 million implantations worldwide, Triathlon has a long clinical history. Persona Knee. Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. In this 2-arm randomized controlled study the primary endpoint is implant migration measured by RSA. Pair it with ROSA Knee and the Personalized Alignment technique In one of the largest knee implant settlements, Sulzer Medica agreed to pay $1 billion to settle roughly 4,000 lawsuits over its hip and knee implants in 2002. A computer-generated random allocation sequence will be used. It incorporates an Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02269254. March 12, 2015- FDA categorized Zimmer Persona Knee recall as "Class II Recall." Zimmer Persona Knee Reviews. 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). Choosing to participate in a study is an important personal decision. The research assistant handling both standard RSA as well as dynamic RSA analysis is also unaware of which prosthesis the participant has received. The hiring of a lawyer is a very important decision that should not be based solely upon advertisements. This cautionary statement is applicable to all forward-looking statements contained in this news release. Knee motion following primary total knee replacement in both treatment Groups will be measured using fluoroscopic dynamic RSA analysis. 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. Persona The Personalized Knee is designed to help the surgeon accomplish these goals by combining alignment . This will insure sufficient statistical power despite intraoperative exclusion and dropout of 40% at last follow-up and . 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. assemble, so we created a matte finish. It is made up of the lower end of the thighbone (femur), the upper end of the shinbone (tibia) and the kneecap (patella). Floor Coatings. Improvements in surgical techniques and implant materials have helped make total knee replacements one of the most successful procedures in all of medicine, according to the AAOS. The patients will be followed for survival through The Danish Knee Arthroplasty Registry. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. At the end of the project all patient related data are destroyed. Vivacit-E Vitamin-E Highly Crosslinked Polyethylene 31:32. List: Every abusive Catholic Church priest, clergy member named in every state in the past year. 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. 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. to be accurate, but we didnt want to stop with just being precise. cases. To make ordering easier, please have your customer number, the catalog number and the quantity of items you wish to order. fit better and instruments designed for ease of use, without the 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. Please remove one or more studies before adding more. Zimmer Biomet- ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. postoperatively, we believe a system needs to include implants that Femur specs:Anatomic design with21 distinct profilesin2mm Could we be more bone conserving? 7d. Rheumatoid arthritis causes painful swelling that can eventually lead to bone loss and joint deformity. 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. All sensitive personal data regarding participants will be stored in accordance with guidelines presented by the Personal Data Act. the native tibia as possible. The study's primary outcome measure is implant migration measured by RSA. These options Vitamin-E Polyethylene, all built upon the heritage of the You have reached the maximum number of saved studies (100). Statistics A professional statistical software package will be used when processing data in this project. Instrumentation Surgical Technique, Persona The Personalized Knee Clinical Summary, All content herein is protected by copyright, trademarks and other 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. iData on file with Zimmer Biomet: The Persona OsseoTi Keel Tibia Provides Strong Initial Fixation. Participant inclusion All participants will receive oral and written information about the project before consent. 4027.1-GLBL-en, 345 E. Main St.Warsaw, IN 46580www.zimmerbiomet.com, View original content to download multimedia:https://www.prnewswire.com/news-releases/zimmer-biomet-expands-persona-knee-system-portfolio-with-fda-clearance-of-persona-osseoti-keel-tibia-for-cementless-knee-replacement-301683440.html, https://www.zimmerbiomet.com/en/products-and-solutions/specialties/knee/persona-osseotikeeltibia.html, https://www.prnewswire.com/news-releases/zimmer-biomet-expands-persona-knee-system-portfolio-with-fda-clearance-of-persona-osseoti-keel-tibia-for-cementless-knee-replacement-301683440.html, California Transparency in Supply Chain Act Disclosure. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Patients who received the uncemented device may be eligible for financial compensation in the form of a settlement. percent of painfulTotal Knee Arthroplasty (TKA) The theoretic proposed benefit of MC polyethylene bearing is improved kinematics mimicking native knee motion. Femoral component: Only cemented femoral components will be used for this study. Radiolucent lines, which are tiny cracks between the device and the bone where fluid and debris can get trapped, can also lead to bone loss, a condition called osteolysis. A total score is calculated ranging from -0.624 (worst) to 1 (best). More than a thousand lawsuits were filed against Zimmer Inc. in recent years over its NexGen knee implant. Why Should I Register and Submit Results? options including minimal constraint to full constraint, left and Polyethylene materials: Conventional polyethylene will be used for patients >65 years old and Vitamine-E infused poly insert for patients 65 years old. Select variants from the 2016 Swedish National Registry available at All measurements in inches. Market Strategies International. In designing the Persona Knee, we identified several For more information about the Persona OsseoTi Keel Tibia, visit https://www.zimmerbiomet.com/en/products-and-solutions/specialties/knee/persona-osseotikeeltibia.html. Publications The results of this project are expected published in an international medical journal. 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. The Persona OsseoTi Keel Tibia is also complemented with a new cemented implant option to enable seamless versatility for the surgeon during the procedure. Building on a clinically proven legacy,11,12thePersona 2023All rights reserved 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. Altered pain perception and / or neurologic affection due to diabetes or other disorders. Knee replacement lawsuits claim the devices loosened, became unstable and required revision surgery to correct the problems. This type of arthritis occurs after a traumatic knee injury. doi: 10.1136/bmj.f7592. 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. Adverse Events including intraoperative complications and revisions at any post-operative time points. This project is financed by Zimmer-Biomet, Warsaw, Indiana, USA. 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. Body Measurements Table. A/P sizes. Instrumentation and technology really The Persona Knee System gives you the ability to address the unique The devices to be used in this project are: The Zimmer-Biomet Persona Total Knee System. If you are visiting any of our drug pages please note: The FDA approved this medication after it determined that the benefits of the product outweigh the known risks for the intended use. Latest ODEP ratings can be Epoxy Flooring UAE; Floor Coating UAE; Self Leveling Floor Coating; Wood Finishes and Coating; Functional Coatings. Signed consent, however, is to be given latest at admittance before surgery. 2023 Major Media Consulting Inc. | Privacy Policy | All Rights Reserved. Therefore new implants are introduced to the marked with the theoretical benefit of improved implant survival and superior patient reported outcomes. You should expect your instruments Persona The Personalized Knee is designed to help the surgeon accomplish these goals by combining alignment accuracy with a simple, straight-forward technique. Tibia specs:Anatomic disproportional M/L growth, 9 sizes, left and If your measurements fall between two sizes, we recommend to select the larger size (but you may try both sizes on if possible). Amanda Pedersen | Aug 30, 2021. According to the agency's database, there were nearly 1,300 recalls on knee replacement systems or components between 2003 and 2019. Report. Participants are informed about the right to having a dependent present when project information is given. Allocation of the participants to one of the two treatment groups is done intraoperatively. knee design. With 90+ years of trusted leadership and proven expertise, Zimmer Biomet is positioned to deliver the highest quality solutions to patients and providers. design locking mechanism, no lock-down screws or through holds, made ofTivaniumAlloy. Persona Partial Knee has its own clinical results too! Thanks to advances in technology and surgical techniques, the majority of knee replacements are successful and provide extensive pain relief to patients. 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 In this study 2 x 30 participants are included. Specifications and prices are subject to change without notification. Annually 40 TKA procedures are performed in our department, of which about 70% is Osteo Arthritis (OA) and 30% Reumatoid Arthritis (RA). Keywords provided by R.G.H.H. 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. information.To obtain a copy of the current Instructions for Use 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. An XL is usually equivalent to 1X, and an XXL is like a 2X. Participants may be excluded intraoperatively if the PCL is found insufficient and LPS prosthesis is required. Fit really matters. The Zimmer Persona has been the subject of numerous recalls, mostly for unintentional manufacturing defects. We do not use cookies for targeted or behavioral advertising on this website. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Product Manufactured in and Exported from the U.S.: Radiostereometric analysis (RSA) [TimeFrame:2 years after postoperatively], Radiostereometric analysis (RSA) [TimeFrame:3 months postoperatively], Radiostereometric analysis (RSA) [TimeFrame:1 year postoperatively], Oxford Knee Score (OKS) [TimeFrame:Change from preoperative to 3 months postoperative OKS], Oxford Knee Score (OKS) [TimeFrame:Change from preoperative to 1 year postoperative OKS], Oxford Knee Score (OKS) [TimeFrame:Change from preoperative to 2 years postoperative OKS], Oxford Knee Score - Activity & Participation Questionnaire (OKS-APQ) [TimeFrame:Change from preoperative to 3 months postoperatively], Oxford Knee Score - Activity & Participation Questionnaire (OKS-APQ) [TimeFrame:Change from preoperative to 1 year postoperatively], Oxford Knee Score - Activity & Participation Questionnaire (OKS-APQ) [TimeFrame:Change from preoperative to 2 years postoperatively], EuroQol 5-dimension (EQ-5D) [TimeFrame:Change from preoperative to 3 months postoperatively], EuroQol 5-dimension (EQ-5D) [TimeFrame:Change from preoperative to 1 year postoperatively], EuroQol 5-dimension (EQ-5D) [TimeFrame:Change from preoperative to 2 years postoperatively], Forgotten Joint Score (FJS) [TimeFrame:Change from preoperative to 3 months postoperatively], Forgotten Joint Score (FJS) [TimeFrame:Change from preoperative to 1 year postoperatively], Forgotten Joint Score (FJS) [TimeFrame:Change from preoperative to 2 year postoperatively], Dynamic RSA [TimeFrame:1 year postoperatively], Radiolucency / osteolysis [TimeFrame:immediate postoperatively and 1 and 2 years postoperatively], Adverse Events [TimeFrame:Through study completion, up to 2 years postoperatively], Clinical and radiological osteoarthritis of the knee set to receive a primary unilateral total knee replacement, Participants must be able to speak and understand Danish, Participants must be able to give informed consent and be cognitively intact, Participants must be able to complete all post-operative controls, Participants must not have severe comorbidities, American Society of Anesthesiologists Physical Status Classification System (ASA) score 3, Clinically suitable to receive a Cruciate Retaining (CR) implant (no severe deformity and/or ligament instability). Arthritis is characterized by inflammation and stiffness in the joints and can reduce a persons range of motion. Persona Total Knee System with a CR polyethylene liner. The settlement averaged $200,000 per patient. to deliver personalized patient care. of Primary Total Knee Replacement with Hybrid Fixation. 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. Bust. In the largest knee replacement lawsuit settlement, Sulzer Medica paid $1 billion to settle 4,000 hip and knee implant cases. 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. Declaration For California Compliance Law, Zimmer Biomet Bone Healing Technologies Notice of Privacy Practices. 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). 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. for each patient and restore the unique identity of every knee anatomy. since served a purpose, we wanted an implant that fit as close to 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. atlas. The primary investigator will process all data. Prior surgery on the affected knee that includes osteosynthesis, anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) and/or collateral ligament surgery. *Prices are pre-tax. Zimmer Persona Trabecular Metal Tibial Plate / Persona TM Tibia Number Recall: 11,658 Reason: Increase in complaints of radiolucent lines and loosening. You have reached the maximum number of saved studies (100). 2 Femur Exposure SECTION2 . BMJ. In case only one of the bones has insufficient markers, the patient will be followed for the other bone. instrumentation were designed to help you consistently achieve optimal outcomes. 1961 May 27;1(7187):1129-32. doi: 10.1016/s0140-6736(61)92063-3. 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. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568123. 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. create ergonomic instrumentation.6 We wanted to reduce Tapered Screw-Vent Implant System Product Catalog. This site does not provide legal advice. RSA is performed postoperatively and at all outpatient follow-ups. "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. 7g. 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. The Persona Revision Knee System expands the Persona Knee System to Implant shape and fit matter in achieving postoperative patient 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. patient care with ease and efficiency, Modern tools to help your orthopedic surgery center, Personalizedstrategyandsolutionsfor yourambulatorysurgerycenter. Metal Surgical Technique, ZimmerFuZion Instruments Surgical Technique, Persona Trabecular Metal Femoral Component Surgical Technique, Persona Primary Knee: Flexion-First Balancing For example, womens body shapes differ from that of men, resulting in a slightly different range of motion. representative; search this website for additional product was created. You will need the Adobe Reader to view and print these documents. More than 4.5 million Americans are living with a prosthetic knee implant called a total knee replacement. 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 We strive to alleviate pain and improve the quality of life for people around the world. With that, the Persona Anatomic Tibia Journal of Bone Radiographically verified radiolucency / osteolysis. (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. Prosthesis placement and bone resection measured by means of CT and caliper measurements of the resected bone parts. Zimmer, Inc. 1800 West Center Street Warsaw, Indiana 46580USA. 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.) 2016 Sales data [TimeFrame:2 Years], Knee Prosthesis motion by means of Fluoroscopy. Instrumentation and technology really matters. Participants will receive oral and written information concerning the handling of sensitive personal data. 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.
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