The optetrak constrained condylar implant and specialized instrumentation system allow for restoration, flexibility, stability and simplicity for revision total knee. Average 7year survivorship and clinical results of a. The early innovators of todays resurfacing condylar knees. Patellar and femoral component in total knee arthro. However, a growing number of optetrak knee replacement lawsuit filings allege that versions of the system manufactured in 2011 and 2012 are prone to early failure. Optetrak posterior stabilized versus optetrak hiflex the safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
No changes were made to the other components of the optetrak total knee system. As a result, exactech replaced the problematic components with. Total knee replacement, tools stock image c0014637. Exactech optetrak knee replacement failure lawsuit information. Exac said yesterday that it won fda 510k clearance for its optetrak logic constrained condylar prosthesis for revision knee. Excessive internal rotation of the femoral component in relation to the femoral posterior condylar axis can lead to knee pain and stiffness. The earliest types of total knee arthroplasties were pure tibiofemoral replacements, primarily designed to treat severe axial deformities and intractable knee pain in patients affected by either tuberculosis or rheumatoid arthritis 47, 4, 150, 152. It was presented as a successor to the total condylar prosthesis 4 insall j. The optetrak total knee systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, patients without sufficient soft tissue integrity to provide. Exactech optetrak lawsuit filed over knee implant failure.
Similar to a navigation device in your car, this advanced platform provides a visual map of the. Poor results of the optetrak cemented posterior stabilized knee. The optetrak cemented posterior stabilized knee prosthesis exactech, gainesville, fl, usa was launched on the market in 1995. 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. A consecutive group of 7 patients 171 knees who underwent tkas using the optetrak ps knee prosthesis between october 1997 and march 2004 were followed for an. Knee1 is committed to helping you choose the best and safest options for treating your knee. Compared group with knee oa receiving supervised manual therapy and exercise to group receiving home exercise. Depuy synthes attune, exactech optetrak and arthrex. The 1970s were selected because most innovations occurred during those years. Traumatic dislodgement of tibial polyethylene insert after.
To that end, we have developed this resource to provide the information you need to ensure your knee surgery goes as smoothly as possible. Listing a study does not mean it has been evaluated by the u. Exactech optetrak knee legal help if you or a loved one has suffered similar damages or injuries, please fill in our form and your complaint will be sent to a. While not all recipients have problems, failure of this optetrak replacement were due to a faulty piece of the knee system.
Included in the study were 81 military personnel, all of whom played sport regularly, and who had been suffering from anterolateral knee pain for approximately months. Knee ligaments account for of all reported skiing injuries the largest percentage by far of any injury in the history of the sport, affecting every kind of skier on every kind of terrain. If you or a loved one had problems after knee replacement surgery, you should contact our law firm immediately. Optetrak knee lawsuit filed in georgia exactech knee.
Exactech optetrak knee failure knee replacement lawsuits. No changes were made to the femoral or patellar components of this system. The suit was filed by plaintiff diane stanesic, who alleges that she underwent a total knee arthroplasty with a. 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. Femoral component alignment is an important consideration during tka because of its influence on patient dissatisfaction, anterior knee pain, and longterm implant survival. Optetrak logic primary knee system total knee arthroplasty. Citescore values are based on citation counts in a given year e. 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. History of condylar total knee arthroplasty 207 in 1978 prosthesis insallburstein was designed to correct these problems by replacing the posterior cruciate ligament with a mechanical lock to reduce posterior translation of the femoral component by using a mechanism of a cam articulated with a post on the tibial component fig. This can result in an extended absence from work and unplanned medical expenses. As a result of the defective the optetrak knee replacementnature of procedure, persons who were implanted with a defective device, including plaintiff, have sufferedand, may continue to suffer, severe and permanent personal injuries, including painful knee revision. This paper is an effort to identify the innovators who contributed to the development of todays condylar total knee prostheses and the surgical techniques used to insert them.
In 20, the exactech went to a fit tibial tray on its optetrak knee implant. Optetrak posterior stabilized versus optetrak hiflex. They frankly ignored the patellofemoral joint, and associated patellar complications were often treated rather nonchalantly with. Robinson on exactech optetrak total knee replacement. The controversy of patellar resurfacing in total knee. If all goes well, a knee replacement should last at least 15 years. The depuy synthes attune knee system has received more than 230 fda reports of early failure. Traumatic dislodgement of tibial polyethylene insert after a high. Exactech wins fda 510k for optetrak knee prosthesis. 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. When a knee implant fails, it must be corrected with an additional surgery. Pdf traumatic dislodgement of tibial polyethylene insert after a.
This booklet is based on an open, 26month study published in 2008. This prompted victims to sue the maker, exactech, inc. From a simplified, bonepreserving technique to efficient, tissuesparing instrumentation, optetrak logic ps streamlines efficiency in the o. Many pathologic entities can produce a painful total knee replacement tkr that may. Optetrak logic primary system developed for excellent longterm implant survivorship. Exactech optetrak knee replacement lawsuits mcgartland. The revision knee system is composed of proprietary net compression molded polyethylene and is indicated for use in skeletally mature patients undergoing surgery for total knee replacements due to. Pennsylvania woman alleges complications from exactech knee replacement. Total knee arthroplasty, cemented knee prosthesis, posterostabilized. 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. Nfrmc acquires exactech system for orthopedic surgery. All surgeries were performed with the same protocole and by using the same optetrak cc knee components exactech, gainesville, fl. Knee replacement lawsuits claim the devices loosened, became unstable and required revision surgery to correct the problems.
Optetrak revision knee system total knee arthroplasty. Optetrak logic primary system of implants uses timetested patented design and proprietary materials for bone preservation, proper kinematics and wear. The 1970s saw an explosion of ideas in the field of prosthetic knee arthroplasty. It was presented as a successor to the total condylar prosthesis and the insallburstein posterostablized prosthesis of the insallburstein ii ibii type. Together they created the knee resource to assist healthcare professionals to make better decisions and provide patients with information and guidance about their knee problem. March 2016 surgical technique using gps navigation and modified gap balancing. Optetrak revision system the optetrak constrained condylar implant and specialized instrumentation system allow for restoration, flexibility, stability and simplicity for revision total knee replacement. Exactech optetrak knee replacement recall lawsuit attorneys. 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.
Depuy attune, zimmer nexgen and arthrex ibalance are among the knee implants named in lawsuits. We evaluated the average 7year survivorship and clinical results of a newer primary posterior stabilized total knee arthroplasty tka. Indications for the revision tka were 1 revision of a primary tka or unicondylar knee arthroplasty n27 or 2 revision of revisiontka n15. The optetrak knee replacement system has been on the market since 1994, but in 2008, the company began receiving reports of early failure of the devices tibial tray. However, only 3 tibial insert dislocations in primary fixedbearing highflex posteriorstabilized tkrs have been. Manual therapy and exercise delivered to lumbopelvic, hip, knee, foot and ankle regions based on reduced motion or pain in these regions.
Pdf many pathologic entities can produce a painful total knee replacement tkr that may lead to. Unfortunately, the new finned tibial tray may not adequately bond the metal implant to the patients knee bones. The optetrak comprehensive knee system offers primary femoral components in cruciate retaining cr as well as a bonesparing. Exactech optetrak and arthrex ibalance are knee replacements that are already causing problems. Polyethylene insert dissociation from the tibial baseplate has been described most frequently after mobilebearing and cruciateretaining tkrs.
The full text of this article is available in pdf format. Compared to the latter, the optetrak proposed several. Exactech knee class action lawsuit knee replacement lawsuits. Midterm results of optetrak posteriorstabilized total. Many pathologic entities can produce a painful total knee replacement tkr that may lead to potential prosthetic failure. If you received an exactech optetrak knee implant and are now experiencing any of the mentioned symptoms, it is important that you seek medical attention as soon as possible.
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 logic system of implants uses timetested patented design and proprietary materials for bone preservation, proper kinematics and wear management in total knee replacement. Midterm results of optetrak posteriorstabilized total knee system after 7 to 12 years in a university hospital article in the journal of arthroplasty 268. All operations were performed by a single senior surgeon. The modifications in this design included a deeper patellar sulcus aimed at reducing contact stresses, improving patellar tracking, and achieving greater maximum flexion.