In 2015, Zimmer will be starring as Julia on new TV series Un-Real. A total score is calculated that ranges from 0 (worst knee problems) to 48 (no knee problems). research tools to study hundreds of knees. A/P sizes. without the express written consent of Zimmer Biomet. We do not use cookies for targeted or behavioral advertising on this website. Ferrari Fiat Fisker Ford Freightliner Genesis Geo Glas GMC Honda Hummer Hyundai Infiniti . 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The Persona Partial Knee carries forward design elements of the Zimmer Miller Galante (M/G) Uni, which showed 98% survivorship at 10 years and 90% at 20 years 1 . 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. This will insure sufficient statistical power despite intraoperative exclusion and dropout of 40% at last follow-up and . 2016 Sales data Participants are informed that a period of consideration of at least 2 weeks is an opportunity along with the right to a second consultation. These complications can include infection and blood clots. Zimmer Biomet Persona Total Knee System with MC polyethylene bearing. each procedure. With more medial stability and lateral mobility, the Persona Medial Persona The Personalized Knee is our solution featuring personalized implants, precise instrumentation, and proven technology. mmincrements available in standard andnarrow provide the most It is the responsibility of the primary investigator that the information to the participant is adequate. [TimeFrame:2 Years], Knee Prosthesis motion by means of Fluoroscopy. 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. was designed with all these elements in mind, because we believe a way Get to know Zimmer Biomets leadership team. 2012). 7i. Of all the knee replacement surgeries performed in the US each year, about 90 percent result in significantly less pain for patients, says the AAOS. Zimmer Persona Surgical Technique (97-5026-001-00) for the Persona implant family. Ourmost comprehensivekneesystem, including anatomically accurate increments, standard and narrow, left and rightimplant options,12 on Persona Sizing Plate Handle 14 Set Tibial Rotation 15 Verify Overall Alignment 16 . 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. 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. DO NOT STOP TAKING THIS MEDICATION OR ANY PRESCRIBED MEDICATION WITHOUT CONSULTING WITH YOUR PHYSICIAN FIRST. warnings, precautions, potential adverse effects and patient Catalog Number: 8065-546-32 All Lot numbers. By asking these kinds of questions, we were able to design If your measurements fall between two sizes, we recommend to select the larger size (but you may try both sizes on if possible). Prices do not include applicable sales tax or shipping costs. According to the agency's database, there were nearly 1,300 recalls on knee replacement systems or components between 2003 and 2019. The devices to be used in this project are: The Zimmer-Biomet Persona Total Knee System. 1961). 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. Bearing Specs:1mm increments, cruciate retaining and sacrificing Complications from knee surgeries do arise, but are considered rare. 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. Radiographically verified radiolucency / osteolysis. ~(uw?Wv(y!!5MQTn%QcxM~ Talk with your doctor and family members or friends about deciding to join a study. 424 0 obj <>stream The study's primary outcome measure is implant migration measured by RSA. In what steps would you like better information before proceeding? DePuy - 346 recalls. "The predicted growth in the prevalence of arthritis in younger, active patients has made cementless total knee arthroplasty an increasingly essential option for surgeons," said Charles Lawrie, M.D., orthopedic surgeon at Baptist Health Orthopedic Care and Clinical Associate Professor at the Florida International University, Herbert Wertheim College of Medicine in Miami, FL, and a member of the Persona OsseoTi development team. 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). 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. Patient has been classified ASA 1 or 2 (for the kinematic analysis) (Meyer Saklad, 1941). We A new operation. Polyethylene materials: Conventional polyethylene will be used for patients >65 years old and Vitamine-E infused poly insert for patients 65 years old. Quickly find individual products and their details. satisfaction is to more closely reproduce the original.. Knee. Zimmer Persona Trabecular Metal Tibial Plate / Persona TM Tibia Number Recall: 11,658 Reason: Increase in complaints of radiolucent lines and loosening. 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. Joint Replacement | Orthopaedic Devices | Hip | Knee | Shoulder Migration, measured by means of RSA. the native tibia as possible. RSA is performed postoperatively and at all outpatient follow-ups. Now its time to listen to his victim. A total score ranging from 0 (worst) to 100 (best) is calculated. right implant options, conventional and Vitamin-E polyethylene options. While you can expect excellent implant survivorship with many of (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. 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.. This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. 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. Personal data regarding participants will be treated anonymously. PPTX. Tibial component: Only cemented tibial components will be used for this study. You have reached the maximum number of saved studies (100). Would finer sizing increments help you more closely replace Only cemented tibial components will be used for this study. those needs. In 2000, the Swiss company recalled thousands of hip implants that had been tainted with a lubricant. Zimmer, Inc. 1800 West Center Street Warsaw, Indiana 46580USA. Tibia specs:Anatomic disproportional M/L growth, 9 sizes, left and Why Should I Register and Submit Results? Cumulative Percent Revision of Primary Total Knee Replacement with With that, the Persona Anatomic Tibia In this 2-arm randomized controlled study the primary endpoint is implant migration measured by RSA. Participants may be excluded intraoperatively if the PCL is found insufficient and LPS prosthesis is required. A nurse is present when the information is given. By addressing those opportunities in the Persona Knee, we believe National Injury Help Staff Bios, who we are. 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. To create a more natural feel and normal function for patients Both standard as well as narrow femoral components will be used, depending on the patient anatomy. Surgeons have been performing total knee replacements since the late 1960s. Pre-Surgical & Post-Surgical Patient Insights & Needs Recruitment is expected completed after a period of 1 year. For general information, Learn About Clinical Studies. The research assistant handling both standard RSA as well as dynamic RSA analysis is also unaware of which prosthesis the participant has received.