The exactech optetrak knee replacement system has been on the market since 1994. Exactech optetrak knee implant complications lawsuits. Now, several patients have filed lawsuits against exactech, alleging that premature failure of. Some of these implants have been used in common surgical procedures such as hip replacement and knee. Mechanical testing of fixation strength of a divergent peg glenoid component.
Our exactech knee replacement lawsuit attorneys and our partners are filing optetrak knee replacement lawsuits throughout the country. According to reports in the fda manufacturer and user facility device experience maude database, there have been numerous reports of early failure of exactech optetrak devices. Tibial insert an implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision bicondylar knee joint replacement. The optetrak unicondylar knee system provides for bone preservation.
Our dangerous device attorneys can help if you or someone you care about was harmed by knee replacement surgery. Prosthetic knee implants are generally made of two pieces, a larger component that fits on the end of the thigh bone, and a smaller plate that is placed on the top of the shin bone. Knee system solutions to address clinical challenges in primary and revision total knee replacement. Defendants were aware that early failures of the optetrak knee implants required recipients of the optetrak knee implant to undergo revision surgeries to remove the defective device. This instrument was used in 70% of the cases in the study. The optetrak constrained condylar implant and specialized instrumentation system allow for restoration, flexibility, stability and simplicity for revision total knee replacement. We began to use the optetrak knee system exactech, gainesville, fla in 1995 to change to a more modern articular design in total knee arthroplasty and improve patellofemoral complications. Exactech optetrak knee replacement lawsuits mcgartland. Midterm results of optetrak posteriorstabilized total. No changes were made to the other components of the optetrak total knee system. Exactech reconfigured its optetrak knee replacement system for its 2011 and 2012 models to feature a tibial tray with a finned design. Knee replacement lawsuit 2020 settlements and recall data. Knee replacement implant lawsuits if you or someone you know has experienced serious complications following knee surgery, you may be entitled to compensation due to a defective knee implant.
Exactechs claimed optetrak survival rates are materially false and. Exactech optetrak knee replacement dudley debosier injury. Optetrak logic primary knee system total knee arthroplasty. The optetrak a comprehensive knee system orthopaedic. New bioglass could change knee surgery 3d printing industry. Exactech optetrak knee failure knee replacement lawsuits. It was presented as a successor to the total condylar prosthesis and the insallburstein posterostablized prosthesis of the insallburstein ii ibii type. Optetrak posterior stabilized versus optetrak hiflex the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The optetrak cemented posterior stabilized knee prosthesis exactech, gainesville, fl, usa was launched on the market in 1995. Complaints regarding the design of the exactech optetrak knee replacement are coming to light, particularly allegations of early implant failures due to defective design. Younghoo kim, the joint replacement center, ewha womans. Traumatic dislodgement of tibial polyethylene insert after a high. The optetrak knee replacement is the subject of a growing number of lawsuits alleging that certain versions suffer from high rates of early failure.
In orthopedic surgery, 3dimensional printing has been used for a number of different applications. How to 3d print beginners guide to 3d printing 3d insider. How do i reducecompress pdf file size from scanned document hp photosmart premium. Exactech optetrak knee replacement failure lawsuit. Upon information and belief, the first optetrak knee device became available to be implanted in a patient in 1994. Improvement on meniscectomy surgeries to be offered soon.
The optetrak knee implant is a device used in knee replacement surgeries that is manufactured by exactech, inc. Knee conditioning program orthoinfo aaos from the american academy of orthopaedic surgeons. Lawsuits have been filed against exactech by both patients and their families seeking compensation for injuries caused by the optetrak devices. Optetrak logic is an advanced approach to total knee replacement that. The optetrak logic total knee system is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, andor posttraumatic degenerative problems.
Nfrmc acquires exactech system for orthopedic surgery north. We evaluated the average 7year survivorship and clinical results of a newer primary posterior stabilized total knee arthroplasty tka. Poor results of the optetrak cemented posterior stabilized knee. A guide to recovering from knee replacement surgery duration.
Food and drug administration fda has added numerous reports of early failure of the exactech optetrak knee replacement system to its manufacturer and user facility device experience maude database. A total knee replacement procedure removes the damaged portion of the femur or thigh bone, the tibia or shin bone, and the patella or knee cap, replacing them with metal andor plastic components that will replicate the knee s natural movement and function. Pdf traumatic dislodgement of tibial polyethylene insert after a. Exactech wins fda 510k for optetrak knee prosthesis. A comprehensive knee system that addresses your concerns for contact stress, patella tracking, polyethylene wear, joint stability and bone preservation. We sat down with raymond robinson, md to get his thoughts on longevity in total knee replacements and his longterm clinical results with the optetrak knee system. The modifications in this design included a deeper patellar sulcus aimed at reducing contact stresses, improving patellar tracking, and achieving greater maximum flexion.
Optetrak logic tibial insert posterior stabilizedmatch component colors 6 yellow, 11mm, use with logic femoral and tibial componentsref 02012356011. There have been no changes to the material of the predicate optetrak tibial tray components. You will learn the basic history of 3d printing, the software that powers it, how the hardware works, and other crucial. Exac, a developer and producer of bone and joint restoration products for hip, knee, shoulder, spine and biologic materials, announced today it has received clearance from the u. Optetrak logic is an advanced approach to total knee replacement that introduces modern design features and intuitive instrumentation while building on the. Comparison of the posterior cruciate sparing and posteriorly stabilized designs. This deviation directly contradicts the optetrak instructions for use, which clearly specifies optetrak comprehensive knee system components should be. If you have undergone an optetrak knee replacement surgery to treat arthritis, mobility issues or another health condition, you may be at risk for experiencing painful and damaging complications as. By at least april 2008, defendants were internally discussing the cause of early onset optetrak knee implant failures. Optetrak has proven successful in significantly reducing lateral retinacular release rates and the incidence of peripatellar fibrosis. Clinical performance of the optetrak total knee prosthesis.
Cool as anything, 3d printers are not just about printing fun gizmos. Listing a study does not mean it has been evaluated by the u. Total knee arthroplasty, cemented knee prosthesis, posterostabilized. Please make sure you are printing at 100% or actual size to the rulers will stay true to size. Prosthesis, knee, patellofemorotibial, semiconstrained, cemented, polymermetalpolymer product code jwh. The exactech optetrak is a knee replacement system made from several materials, including polyethylene and chromiumcobalt alloy. However, that design may have reduced the devices ability to adhere to the surgical cement used during the operation, making it prone to early failure. There have been no changes to the material of the predicate optetrak tibial tray. Optetrak posterior stabilized versus optetrak hiflex full. Ps, and fixedbearing exactech optetrak highflex prosthesis miami, florida, usa. A 11year followup study younghoo kim1, jangwon park2 and junshik kim2 1the joint replacement center, seonam hospital, seoul, republic of korea 2 the joint replacement center, ewha womans university mokdong hospital, seoul, republic of korea corresponding author.
Compared to the latter, the optetrak proposed several. Class 2 device recall optetrak logic tibial insert. A steady stream of filings around the country followed. Another example of guided motion knee is represented by the medial pivot knee wright mfg co, memphis, tn. It was presented as a successor to the total condylar prosthesis 4 and the insallburstein posterostablized prosthesis of the insallburstein ii ibii type 5. Predictive factors for failure after total knee replacement. More specifically, the early failure reports indicated something wrong with the devices tibial tray component. Initiate gentle strengthening exercises with the primary goal of activating the quadriceps.
Optetrak knee replacement linked to severe complications. The use of total knee arthroplasty tka in treatment of chronic degenerative. Knee supports surgeon goals for reproducible clinical outcomes wide array of options for improved versatility modified implant design to. Knee replacement lawsuits claim that medical device companies failed to warn patients about potential dangers. Exacteclr operative technique ac mprehensive knee y tem constrained. Severe cases of osteoarthritis with ligamentous instability require the use of a modular knee arthoplasty. Pennsylvania woman alleges complications from exactech knee replacement january 19, 2018 a woman from west mifflin, pennsylvania, claims in a new products liability lawsuit that she was injured by a defective exactech optetrak knee replacement device. The optetrak prosthesis includes a cemented femoral implant in cobaltchromium alloy that is anatomic and asymmetrical. Biomechanical testing of various methods of reconstruction for a posterior cruciate ligament deficient knee. Many pathologic entities can produce a painful total knee replacement tkr that may lead to potential. Mar 09, 2017 replacement knees fresh off the 3d printer. The knee joint joins the thigh with the leg and consists of two articulations. Knee replacements are only available in specific sizes, meaning that often the knee replacement will not fit right. We used the optetrak condylar constrained cck implant, a modular and constrained knee implant as replacement for a failed primary arthroplasty, to assess the survivorship, the complications, the clinical, radiological, and functional situation, and the quality of life of those patients in whom a cck had been implanted in recent years in order to find predictive preoperative.
Patients report problems with the exactech optetrak knee. Since 1994, defendants have obtained 510k clearance for various optetrak devices and tibial inserts including the optetrak ps, optetrak hiflex ps, optetrak finned tibial. It is the largest joint in the human body and is very complicated. Metal backed tibial components were used in all knees. If you or a loved one underwent an optetrak knee replacement surgery and experienced complications such as pain, infection, mobility issues, additional surgery or more we urge you to contact our product liability attorneys by calling 1. Exactech optetrak lawsuit filed over knee implant failure. Optetrak logic primary system of implants uses timetested patented design and proprietary materials for bone preservation, proper kinematics and wear management in total knee replacement. Theyre a vital part of our bodies, yet sitting most of the day can contribute to tight hip flexors. After a knee injury or knee surgery, an exercise conditioning program will help you return to daily activities and enjoy a more active, healthy lifestyle. In this case, the tibial insert driver should be used to complete the. Anatomical diagram of a human right knee joint poster. Feb 02, 2014 3d printing brings revolution in knee surgeries.
The optetrak logic system of implants uses timetested patented design and proprietary materials for bone preservation, proper kinematics and wear management in total knee replacement. Patients with knee replacement may notice losing movement and range, having unusual pain or swelling. Surgeons around the world have documented excellent optetrak results. Nov 01, 2017 exactech optetrak lawsuit filed over knee implant failure. The results demonstrate stable and natural ap kinematics using the optetrak logic cr design. Jun 25, 2015 exactech receives fda 510k clearance for its optetrak logic constrained condylar prosthesis gainesville, fla. Exactech investor update helping surgeons worldwide make patients more mobile q1 2017. Every year, hundreds of thousands of patients undergo total knee replacement surgery. Request pdf on oct 1, 2012, william petty and others published commentary on an article by c. For patients in need of knee replacements, surgery is often used as a last resort. The view from the side detects any recurvatum or lack of complete extension.
For example, joint replacement implants have been custom fabricated. The advancements in the optetrak logic system has been driven by the goal of improving clinical outcomes, all while maintaining the patented design and proprietary materials that have been proven over the years. The optetrak logic cc total knee system includes the following. Exactech optetrak knee replacement implants are linked to a variety of symptoms. Knee arthritis tips and exercises kaiser permanente. Plaintiffs seek legal damages to pay for treatment, costs of the device, lost income, and other expenses related to problems with the device. Invitro kinematic analysis of the optetrak knee prosthesis. In that prosthesis the femoral component owns a single radius of femoral curvature and a. Primary modular total knee replacement in severe and. Does the patella in your knee system follow the path of least resistance. Your hips are major joints that need care and attention. Knee arthritis tips and exercises 012701005 611 physical therapy stretching exercises these exercises will help maintain range of motion. Exactech knee class action lawsuit knee replacement lawsuits. Food and drug administration to market the optetrak logic.
With a strong lineage, streamlined instrumentation and a proven femoral design, optetrak keeps your patella on the right track. Feb 10, 2014 doctor to 3d bioprint cartilage into knees. But meyers got a new type of knee implant it was made by a 3d printer. Exactech gps combines surgeon expertise with an advanced computer system to perform the patients knee surgery with a goal of advanced accuracy and precision. Accessgudid optetrak logic 10885862247476 no description. Our lawsuits allege that exactech knew that some of the components in its optetrak system were susceptible to early complications leading to the symptoms and side effects noted. Consult exactechs entire knee replacement catalogue on medicalexpo. And like its name indicates, this approach to total knee arthroplasty just makes sense. Contact our knee replacement lawyers today for a free and confidential case evaluation. The aim of this guide is to teach you the fundamental concepts of how to 3d print, and provide you with the tools and resources you need to get started and make an informed choice about buying your first 3d printer. The bisurface knee prosthesis courtesy of kyocera corp. Personalized for a patients unique bone structure and anatomy, exactech gps allows surgeons to decide where to remove bone and place the knee implant in the optimal position.
Pdf many pathologic entities can produce a painful total knee replacement tkr that may lead to. An approach to total knee arthroplasty that has improved clinical outcomes for patients around the world. Optetrak logic cr animation optetrak logic cr is a unique surgical technique and implant system that enables surgeons to plan and perform a cr total knee replacement based on the. Patients this retrospective continuous multioperator study included 111 patients 115knees operated between march 2005 and october 2007 in two orthopaedic units at the lille university.
Poor results of the optetrak cemented posterior stabilized. Unfortunately, the new finned tibial tray may not adequately bond the metal. Exactech knee system clinical results knee arthroplasty. Exactech optetrak knee replacement recall lawsuit attorneys. But thanks to 3d printing, knee surgeries are becoming less painful and more accurate. Class 2 device recall optetrak logic tibial insert posterior. What happens when an exactech optetrak knee replacement. The shaded area represents a live zone, which is surrounded by a rim with a decreased radius to provide constraint at extreme ranges of motion.
However, the surgery isnt without risksespecially if the knee implants that patients receive are defective or prone to early failure. Can i file a defective exactech optetrak knee implant lawsuit. Thelu et al poor results of the optetraktm cemented posterior stabilized knee prosthesis. Average 7year survivorship and clinical results of a newer. National defective medical device attorneys explaining the cause behind exactech optetrak knee failure, and helping clients with their exactech optetrak knee lawsuit.
Exactech optetrak knee replacement dudley debosier. The right track its not just a road were on, its a trail were blazing. There is a long recovery time with knee replacement surgery. To assess the survival, the complications, the clinical, radiological and functional outcomes, and the quality of life of those patients in whom a optetrak condylar constrained knee cck had been implanted as a primary implant. Built on a rich design history and foundation, the optetrak lineage of knee systems. A man from alabama has filed a lawsuit after his exactech optetrak knee replacement failed just a few years after he had knee surgery. Each year, knee replacement surgery provides relief to thousands of people who suffer from moderate to severe knee pain, stiffness, and inflammation. The proposed device modifications involve offsetting the distal portion of the trays stem in the sizes 0, 1 delta, 1, 2, 3,4 and 5. The goal of the following exercises is to regain range of motion while limiting pain and inflammation. Ligamentous balance was estabilixhed first in knee ex tension and then in knee flexion with use of a tensor. Midterm results of optetrak posteriorstabilized total knee system after 7 to 12 years in a university hospital article in the journal of arthroplasty 268. November 1, 2017 a man from alabama who needed revision surgery because his exactech optetrak knee replacement failed prematurely has filed a lawsuit the lawsuit accuses exactech inc. From a simplified, bonepreserving technique to efficient, tissuesparing instrumentation, optetrak logic is designed to meet the demands of todays more active patients while adding to the efficiency of your operating room. Midterm results of optetrak posteriorstabilized total knee.
Posiflex pp8000s10410ud series pp8000 printer, aura thermal printer, serial cable and power supply included, comes with serial, parallel and usb interface installed, black. Thousands of people have filed knee replacement lawsuits in recent years most of which claim the devices loosened because of a design defect or other flaw attorneys in alabama filed the first lawsuit against attune knee replacement manufacturer depuy synthes in september 2017. Optetrak unicondylar knee system peripheral rim on allpoly tibial component limits extreme subluxation. Exac said yesterday that it won fda 510k clearance for its optetrak logic constrained condylar prosthesis for revision knee arthroplasty patients the knee prosthesis is. October 2, 2017 a patient who underwent knee replacement surgery with the exactech optetrak implant has filed a lawsuit against the manufacturer, alleging that the device caused him severe and permanent injuries, as well as the need for rehabilitation and ongoing medical care.
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