The optetrak constrained condylar implant and specialized instrumentation system allow for restoration, flexibility, stability and simplicity for revision total knee replacement. With a strong lineage, streamlined instrumentation and a proven femoral design, optetrak keeps your patella on the right track. Optetrak logic primary knee system total knee arthroplasty. Clinical results of fixedbearing and rotatingplatform. Since 1994, defendants have obtained 510k clearance for various optetrak devices and tibal inserts including the optetrak ps, optetrak hiflex ps, optetrak finned tibial tray, optetrak offset tibial tray, optetrak rbk tibial insert, optetrak rbk tibial tray. March 2016 surgical technique using gps navigation and modified gap balancing. The products discussed herein may be available under different trademarks in different countries. However, fluoroscopy studies have shown abnormal postoperative knee kinematics. From a simplified, bonepreserving technique to efficient, tissuesparing instrumentation, optetrak logic ps streamlines efficiency in the o. The exactechgps knee application seamlessly aligns with your preferred surgical work. Modifications in design intended to improve results of an implant lineage can sometimes have unintended consequences. It was presented as a successor to the total condylar prosthesis 4 insall j.
The optetrak cemented posterior stabilized knee prosthesis exactech, gainesville, fl, usa was launched on the market in 1995. Optetrak fixedand mobilebearing posterior stabilized prostheses. Severe cases of osteoarthritis with ligamentous instability require the use of a modular knee arthoplasty. This deviation directly contradicts the optetrak instructions for use, which clearly specifies optetrak comprehensive knee system components should be.
Improved knee biomechanics among patients reporting a good outcome in knee related quality of life one year after total knee arthroplasty 21 march 2017 bmc musculoskeletal disorders, vol. We determined whether the added constraint resulted in more damage to the post in psc compared to ps inserts. The optetrak comprehensive knee system was developed in consultation. 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. Exactech optetrak knee failure knee replacement lawsuits. Major safety alerts in september 2008 this page is subject. Requests for class ii device statusf digital pathology slide scanner and accompanying image viewer etc 09032014 09282016 20168129 k141119 20168 hajra mazhar university of ottawa. The depuy synthes attune knee system has received more than 230 fda reports of early failure. Total knee replacement, also called total knee arthroplasty, is one of the most successful surgical procedures. In 20, the exactech went to a fit tibial tray on its optetrak knee implant. Failure at the femoral stem extensioncondylar interface in a. Adobe acrobat dc software is the complete pdf solution for working anywhere with your most important documents.
The modifications in this design included a deeper patellar sulcus aimed at reducing contact stresses, improving patellar tracking, and achieving greater maximum flexion. The effect of constraint on post damage in total knee. 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. Exactech optetrak knee replacement recall lawsuit attorneys. The degrees of femoral rotation can now be read directly from the goniometer on. This prompted victims to sue the maker, exactech, inc. A knee replacement patient who allegedly developed severe and permanent injuries after receiving an exactech optetrak implant has filed a products liability lawsuit against the manufacturer in georgia. Tt50 patient monitor neoscope 3d 3d digital video endoscopic system rigidflexible da vinci xi surgical system revivaltm modular revision hip stem dyna. 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. Average 7year survivorship and clinical results of a newer. Optetrak posterior stabilized versus optetrak hiflex the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Average 7year survivorship and clinical results of a.
Upon information and belief the first optetrak knee was implanted in device 1994. Contact our knee replacement lawyers today for a free and confidential case evaluation. Now, several patients have filed lawsuits against exactech. Biomechanical testing of various methods of reconstruction for a posterior cruciate ligament deficient knee. 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. Optetrak logic total knee system, optetrak logic tibial insert posterior stabilized measurement of organ uptake and circulating radioactivity, capintec captus 3000 thyroid uptake system custom medical specialties, inc bottle pvp prep solution fixation, aesculap s4 element 4. Australian orthopaedics national joint registry supplementary. 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.
Dec 21, 2018 arn report list 20181221 free ebook download as pdf file. Exactech optetrak knee replacement failure lawsuit information. No changes were made to the other components of the optetrak total knee system. Knee sprains and strains university of california, berkeley. Mechanical testing of fixation strength of a divergent peg glenoid component. Design modifications of the posteriorstabilized knee. Associate pdf files to always open in reader or acrobat on.
Validation of accelerometer wear and nonwear time classification algorithm. Patients this retrospective continuous multioperator study included 111 patients 115knees operated between march 2005 and october 2007 in. The optetrak posterior stabilized knee exactech, gainesville, fla is the fifth generation of the hospital for special surgery hss knee known as the hss 9 design. The suit was filed by plaintiff diane stanesic, who alleges that she underwent a total knee arthroplasty with. The full text of this article is available in pdf format. It is a modification of the insallburstein posteriorstabilized ps knee zimmer, warsaw, ind. Inferior view of the tibial tray showing the cement pockets and the winged keel. Exactech wins fda 510k for optetrak knee prosthesis.
Every year, hundreds of thousands of patients undergo total knee replacement. This was done to reduce the medial overhang seen in small female rheumatoid patients. Optetrak has proven successful in significantly reducing lateral retinacular release rates and the incidence of peripatellar fibrosis. Total wear scores and scores for wear damage on the anterior post differed among designs. A computedtomographyscanbased template to place the.
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. 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. Such modifications may include improved femoral rollback, improved femoral dislocation resistance, minimized wear, and improved. Exac said yesterday that it won fda 510k clearance for its optetrak logic constrained condylar prosthesis for revision knee arthroplasty patients the knee. 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.
Knee replacement procedures of the 871,472 primary knee replacements, osteoarthritis was the sole stated indication for surgery in 96% of cases. We evaluated the average 7year survivorship and clinical results of a newer primary posterior stabilized total knee arthroplasty tka. Another example of guided motion knee is represented by the medial pivot knee wright mfg co, memphis, tn. The optetrak unicondylar knee system provides for bone preservation. Its the only pdf viewer that can open and interact with all types of pdf content including forms and multimedia. Optetrak knee lawsuit filed in georgia exactech 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 tray, optetrak offset tibial tray, optetrak rbk tibial. Listing a study does not mean it has been evaluated by the u. Three serial slices of the images in which the medial epicondyle andor the lateral epicondyle were visible were selected to detect the sea. If you or a loved one had problems after knee replacement surgery, you should contact our law firm immediately. Operative technique ac mprehensive knee y tem constrained condylar. We report a case of failure at the femoral stem extensioncondylar interface in a zimmer nexgen rotating hinge knee zimmer.
Exactech knee class action lawsuit knee replacement lawsuits. The patients in the experimental group received preoperative 2. Unfortunately, the new finned tibial tray may not adequately bond the metal implant to the patients knee bones. Sep 03, 2012 medical device recalls for august 2012. The patients were assessed clinically and radiographically with rating systems of the knee society. Exactech optetrak and arthrex ibalance are knee replacements that are already causing problems. Exactech optetrak lawsuit filed over knee implant failure. Although stem extensions are valuable in addressing bone deficiencies and improving implant fixation, the stem extensioncondylar interface may be a point of implant failure. Upon information and belief, the first optetrak knee device became available to be implanted in a patient in 1994.
Biomet agc v2 total knee moulded arcomtibial components thermofisher bo0077m, tryptone soya broth ge healthcare signa mr 2239500, 5116064 and 5118162 biorad variant ii turbo hemoglobin testing system with cdm 4. Poor results of the optetrak cemented posterior stabilized knee. Compared to the latter, the optetrak proposed several. Retrieved psc inserts were matched to retrieved ps inserts from the same manufacturer according to patient age, body mass index, and.
In total knee arthroplasty tka, advances in posteriorstabilized ps knee implant designs address patellofemoral mechanics and campost engagement in an effort to reduce patellofemoral pain and improve knee kinematics. Guided personalized surgery precision and accuracy. This is an overlay schematic diagram of the sagittal view of the optetrak ps and ib ps ii knee replacement systems, showing changes in the. Posted by dr angeol r cruzsein ii on december 28, 2017. Primary modular total knee replacement in severe and. Exactech optetrak knee replacement lawsuit exactech is a wellknown knee replacement medical device manufacturer which has been manufacturing and selling knee replacement implants since 1994. Modular stem extensions have become ubiquitous in revision total knee arthroplasty systems. Robinson on exactech optetrak total knee replacement.
One important goal of the procedure is to restore physiological knee kinematics. 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. Comparison of the posterior cruciate sparing and posteriorly stabilized designs. Knee pain is often caused by ligament sprains, muscle strains, or irritateddamaged cartilage. Optetrak posterior stabilized versus optetrak hiflex. Lcs mobile bearing knee ogee pfc sigma cr knee pfc sigma cs knee pfc sigma rp knee pinnacle cup preservation knee prodigy hip replica a hip solution cup solution hip srom hip summit hip trilock hip ultima cemented hip ultima press fit hip vision 2000 hip foundation knee keystone revision hip linear hip revelation hip encore acumatch lseries. Optetrak unicondylar knee system peripheral rim on allpoly tibial component limits extreme subluxation. Depuy synthes attune, exactech optetrak and arthrex. Product profile optetrak unicondylar knee system 111 table 40. Exactech optetrak knee replacement lawsuits mcgartland. Trauma, falls, or sports injuries can produce forces that tear, over stretch or compress the joint or the soft tissue.
No changes were made to the femoral or patellar components of this system. History of condylar total knee arthroplasty 205 fig. The bisurface knee prosthesis courtesy of kyocera corp. Lbs ii exactech pdf catalogs technical documentation. Product profile optetrack constrained condylar cc knee system 112 table 41. Posterior stabilized constrained psc inserts are intended to provide greater varusvalgus and rotational constraint than conventional ps inserts. Exactech optetrak knee replacement complications youtube. In 2012, a study of 110 patients with the exactech optetrak knee replacement warned about poor results and high failure rates 12% of patients needed another surgery within 5 years, 20% of patients needed routine painkillers, and another 22% of the implants were evolving toward tibial implant loosening. Pennsylvania woman alleges complications from exactech knee replacement. 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. The optetrak comprehensive knee system offers primary femoral components in cruciate retaining cr as well as a bonesparing.
Does the patella in your knee system follow the path of least resistance. This instrument was used in 70% of the cases in the study. Optetrak cemented posterior stabilized knee prosthesis. Product bencox m stem bencox hip system and bencox id cemented stem w rectangular multiplace hyperbaric chamber system product family tbs insight t32. These can be a result of a traumatic injury or stress over time. Invitro kinematic analysis of the optetrak knee prosthesis.
If you have had a knee replacement, and have noticed that you are losing movement and range, having unusual pain or swelling, then you may have been issued an exactech optetrak knee replacement. Adobe acrobat reader dc software is the free, trusted standard for viewing, printing, signing, and annotating pdfs. It was presented as a successor to the total condylar prosthesis and the insallburstein posterostablized prosthesis of the insallburstein ii ibii type. Implant design influences tibial post wear damage in. In addition, western ontario and mcmaster universities osteoarthritis. Total knee arthroplasty tka offers an effective treatment for endstage knee osteoarthritis. We sat down with raymond robinson, md to get his thoughts on longevity in total knee replacements and discuss his longterm clinical results with the optetrak knee system. While not all recipients have problems, failure of this optetrak replacement were due to a faulty piece of the knee system. Major safety alerts in september 2008 this page is subject to.
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