each procedure. According to the agency's database, there were nearly 1,300 recalls on knee replacement systems or components between 2003 and 2019. http://myknee.se/en/ (pgs 42-43). PDF Joint Replacement | Orthopaedic Devices | Hip | Knee | Shoulder Information provided by (Responsible Party): Anders Troelsen, Hvidovre University Hospital, Persona Total Knee System with MC polyethylene bearing. We strive to alleviate pain and improve the quality of life for people around the world. Between 1997 and 2009, the number of knee replacements jumped more than 80%, helping to make total knee replacements one of the most common surgical procedures in the US. The Zimmer Persona Knee System is no different. Not available in all states. create ergonomic instrumentation.6 We wanted to reduce The primary objective is to assess and compare migration of the two TKR prostheses (Femoral and Tibial component). An XL is usually equivalent to 1X, and an XXL is like a 2X. not be redistributed, duplicated or disclosed, in whole or in part, Tapered Screw-Vent Implant System Product Catalog. Femoral component: Only cemented femoral components will be used for this study. The Persona Knee was designed with all these elements in repetitive use. The Forgotten Joint Score (FJS) measures the degree of joint awareness. A total of 60 participants are to be included at Hvidovre University Hospital. FDA Clears Zimmer Biomet's Smart Knee Implant | mddionline.com Report. Data will also be aggregated and stored electronically. We seamlessly transform the patient experience through our innovative products and suite of integrated digital and robotic technologies that leverage data, data analytics and artificial intelligence. Anyone considering a lawyer should not rely upon advertisements or self-proclaimed expertise, and independently investigate the lawyer's credentials and ability. Participants are informed about the right to having a dependent present when project information is given. More than a thousand lawsuits were filed against Zimmer Inc. in recent years over its NexGen knee implant. endstream endobj startxref 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. Wear5and Improved strength.6,7, Highly porous material designed to replicate the structure, function right implant options, conventional and Vitamin-E polyethylene options. most widely used and clinically proven total knee system in the 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. Personal data regarding participants will be treated anonymously. The project will be reported to the Danish Data Protection Agency. 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Implants also do not last forever. 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. globally is a NexGen Knee. Open the catalog to page 1. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates. Failure rate of cemented and uncemented total hip replacements: register study of combined Nordic database of four nations. 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. Keywords provided by R.G.H.H. step within the surgical procedure. Radiographically verified radiolucency / osteolysis. Participants are included when signed consent from the participant is obtained. satisfaction. "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. Total knee replacement surgery is typically performed by an orthopedic surgeon, a doctor that specializes in diseases and injuries of the musculoskeletal system, which includes the bodys bones, muscles, cartilage, ligaments and joints. Smith & Nephew - 139 recalls. The secondary objective is to assess and compare clinical data, kinematics, prosthesis placement and patient reported outcome measures. Seemlessly connect, products, services and technologies to elevate This type of arthritis is caused by wear and tear on the joints and usually occurs in people over the age of 50. Tibial component: Only cemented tibial components will be used for this study. iData on file with Zimmer Biomet: The Persona OsseoTi Keel Tibia Provides Strong Initial Fixation. Pair it with ROSA Knee and the Personalized Alignment technique to deliver personalized patient care. As for the RSA study all consecutive patients ("usual care") are included to prevent selection bias in the migration analysis. According to the company, the device is considered the first "smart" knee implant on the market for total knee replacement . This furthered our understanding of native anatomic shape and No abstract available. 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. 7i. 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. 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. Due to the changing demographics of joint replacement, the population of younger patients are seeking options that not only correct their disease or deformity, but do not limit them in activity (Geerdink et al. Ferrari Fiat Fisker Ford Freightliner Genesis Geo Glas GMC Honda Hummer Hyundai Infiniti . Persona OsseoTi is the latest addition to the clinically proven Persona Knee System, and features a new porous version of the Persona anatomic tibia with Zimmer Biomet's OsseoTi Porous Metal Technology, which uses anatomical data in combination with 3D printing technology to build a structure that directly mimics the architecture of human . PDF THE ER SONALIZED KNEE Ti-Nidium Knee - Zimmer Biomet Arthroscopy with meniscectomy / cartilage surgery / house cleaning is allowed. Implant shape and fit matter in achieving postoperative patient 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.
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