Zimmer persona knee replacement recall issued due to failure. Zimmer has been one of the most trusted names in knee replacement for over four decades. Nexgen knee mri, ct persona knee mri, ct natural knee ii system mri, ct psi nexgen surgical technique. Approved for general use by the fda in march of 2012, the persona system saw production numbers of over 11,000. In february 2015, zimmer, a leading orthopedic company, notified customers of its class 2 fda recall.
Aug 21, 2017 the zimmer persona knee replacement system was introduced in late 2012, marketed by the manufacturer as having anatomically accurate components available for a new level of fit tailored to. The introduction came after an extensive research and development process, throughout which it worked with more than 50 orthopaedic surgeons worldwide and utilized analytics from both genders and 1,500 different bone. You may be entitled to compensation by filing a suit against zimmer inc. Zimmer persona knee replacement lawsuit johnson becker. In march 2015, the fda announced a zimmer persona knee recall, impacting an estimated 11,658 artificial knees implanted in individuals throughout the united states, which may pose a risk of early failure and the need for risky revision surgery. This is an advanced addition to the companys portfolio of personalized and. Zimmer knee replacement lawsuit a class ii recall for the zimmer persona trabecular metal tibial plate knee implant was issued on march 12, 2015 by the food and drug administration. Because zimmer is considered the leading maker of knee replacement items, it is their duty and responsibility to make sure that their products are effective and safe. In march 2015, the fda announced a zimmer persona knee recall, impacting an estimated 11,658 artificial knees implanted in individuals throughout the united states, which may pose a risk of early failure and the need for risky revision surgery as a result of design defects with the zimmer persona travecular metal. Zbh, a global leader in musculoskeletal healthcare, recently announced the launch of the persona partial knee system, the latest addition to its portfolio of personalized and anatomically designed knee implant systems. May 05, 2015 portions of the zimmer persona total knee replacement system is being recalled by its manufacturer. If you or a loved one suffered complications after undergoing knee replacement surgery, you should contact our law firm immediately.
Zimmer recalls persona knee implant, patients seek. Listing a study does not mean it has been evaluated by the u. Independent of study participation, patient is a candidate for commercially available zimmer persona knee implants implanted in accordance with product labeling. Since being brought to the market, almost 500,000 knee. Patient is currently participating in any other surgical intervention studies or pain management studies. The launch of the persona partial knee system is the first significant jointly developed new product for the company since the zimmer biomet combination, and reinforces the companys leadership.
Indications for combined persona partial knee system and zimmer gender solutions patellofemoral joint pfj. Zimmer custom knee replacement psi computer assisted knee. In september, zimmer biomet notified users of a software upgrade to the rosa brain system. National injury help zimmer persona recall knee problems. Hcp content posted june 24, 20 in aaos 20 and persona knee system. The zimmer persona knee replacement system was introduced in late 2012, marketed by the manufacturer as having anatomically accurate components available for a. Prosthesis, knee, patellofemorotibial, semiconstrained, cemented, polymermetalpolymer product code jwh. Research shows that surgeons utilizing pka for at least 20% of their annual knee replacements experienced a significant decrease in their revision rate.
Zimmer knee replacement recall, fda warnings, side effects. Zbh announced the global launch of the persona partial knee system on aug 31. Persona total knee arthroplasty outcomes study smart. The recall indicates that the device may loosen and cause the development of radiolucent lines or large gaps between the device and bone tissue. Las vegas, march 25, 2015 prnewswire by employing a customized, more holistic approach to total knee replacement, a new outpatient program from zimmer holdings, inc. Contact your zimmer representative or visit us at nexgen cr trabecular metal tm monoblock implants cat. The personatm personalized knee system is a semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones. Zimmer biomet received fda clearance for its fusionless scoliosis treatment system, the teather, in august and commercially released the persona revision knee system on sept.
Jun 21, 20 zimmer patient specific instrumented psi computerassisted navigation technology using the zimmers most advanced persona knee replacement implants. Our firm is investigating potential class action lawsuits on behalf of individuals affected by the zimmer persona trabecular metal tibial platepersona tm tibia recall. This simulation is based on threedimensional models of the patients anatomy that were derived from medical imaging data using image segmentation. The knee implant component was recalled in march 2015 due to increased reports of loosening. K0726 19, cleared november 21, 2007 device description. Persona the personalized knee system featuring the zimmer psi knee an abbreviated surgery demonstration for patient specific instruments hcp content posted february 24, 2014 in persona knee system and surgical techniques. Zimmer knee replacement leads the way in giving solutions which alleviate pain, bring back mobility as well as enhance the quality of patients. We are investigating potential lawsuits throughout the united states for claims on behalf of victims who received a persona, or nexgen crflex zimmerbrand knee implant that is or may be defective.
Zimmer biometcelgentek deal and new launches at aaos walter eisner fri, march 11th, 2016. Though it was designed for a more active and younger patient, it has already been the subject of multiple fda reports and the recall of one component of the system. Persona the personalized knee system featuring the zimmer. Zimmer persona knee replacement attorneys chicago medical. Zimmer persona knee replacement recall issued due to. Zbh said it is initiating a partnumber specific recall of persona trabecular metal tibial plate instruments and modular brackets. We are investigating potential lawsuits throughout the united states for claims on behalf of victims who received a persona, or nexgen crflex zimmer brand knee implant that is or may be defective.
Chicago, march 20, 20 prnewswire zimmer holdings, inc. Zimmer introduced persona, the personalized knee system, at the 20 american academy of orthopaedic surgeons annual meeting. Please refer to package insert for complete 97725534 rev. The company filed what is described as a rare software anomaly that may. Zimmer persona knee lawsuit filed over failure, need for. The development of the crflex fixed bearing knee is the result of an analysis of the normal knee prosthesis as it undergoes deep flexion beyond. The persona partial knee system is a single use implant intended for implantation with bone cement.
Approximately,000 knee replacement surgeries are performed every year in the united states. Zimmer persona personalized knee system selected as 2014. The nexgen crflex fixed bearing knee is a cruciate retaining prosthesis designed to safely accommodate greater range of motion for cultural, recreational, or work activities that require deep flexion. 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. Zimmer polar total knee arthroplasty tka full text. A class ii recall has been issued for the zimmer persona personalized knee system after it was linked to reports of loosening and radiolucent lines, which could require the need for revision surgery free confidential lawsuit evaluation. Zimmer polar persona tka emea study full text view. Zimmer persona knee implant recalled for loosening risk. Predecessor to the persona system, the nexgen knee system is the most widely used and clinically proven total knee system in the world. An abbreviated surgery demonstration for patient specific instruments. We took the elements that made the nexgen knee and natural knee ii systems so successful and looked for ways to further enhance those designs. However, adverse event reports suggest that a substantial number of these implants may fail within a few years. Zimmer marketed the persona system as a versatile solution.
March 12, 2015 fda categorized zimmer persona knee recall as class ii recall. The latest two attempts are the zimmer persona knee system and the depuysynthes attune knee system. Mar 23, 2015 the zimmer persona knee was marketed as a personalized knee replacement, which was designed to come as close as possible to the remarkable mechanics of the human body. The study will require each site to obtain irb approval prior to study enrollment. All potential study subjects will be required to participate. The schmidt firm, pllc is currently accepting zimmer persona injury cases in all 50 states. Apr 25, 20 the latest two attempts are the zimmer persona knee system and the depuysynthes attune knee system. Zimmer nexgen knee was approved by the fda in 1994, and since that time more than three million nexgen knees have been implanted worldwide.
Zimmer persona knee lawsuit 2018 update personal injury. Because zimmer is considered the leading maker of knee replacement items, it is their duty and responsibility to make. Persona total knee arthroplasty outcomes study full text. The devicemaker has received an unusually high number of complaints involving premature loosening of the implant and poor fixation. When zimmer initially released the zimmer persona knee replacement system, it promised that the replacements would address the needs of numerous patients suffering from a variety of conditions and injuries. Zimmer persona implant 2 questions joint replacement. Dec 09, 2014 os says i am getting a zimmer persona and encouraged me to look it up on their website if i wanted to read about it which, of course, i did. Zimmer persona knee lawsuit 2018 update approximately,000 knee replacement surgeries are performed every year in the united states. Zimmer biomet zbh launches persona partial knee system. May 21, 20 zimmer polar total knee arthroplasty tka the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Patient qualifies for primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following. A component of a knee replacement product known as the persona total knee replacement system has been recalled by the manufacturer. Those patients may have the right to receive compensation.
Os says i am getting a zimmer persona and encouraged me to look it up on their website if i wanted to read about it which, of course, i did. In 2015, zimmer, maker of the persona personalized knee system, announced it was voluntarily recalling a component in the knee replacement device, the persona trabecular metal tibial plate. New approach to total knee replacement zimmer creates. Nexgen cr trabecular metal tm monoblock implants cat. The system is touted as being a more personalized and anatomically accurate knee implant by its manufacturer zimmer biomet. Portions of the zimmer persona total knee replacement system is being recalled by its manufacturer.
Faqs about zimmer persona knee implants more than 4. Zimmer persona knee lawsuit knee replacement lawyer. Knee replacement total knee arthroplasty partial knee. Persona the personalized knee is designed to help the surgeon accomplish these goals by combining alignment accuracy with a simple, straightforward technique. The knee replacement system by zimmer was the primary driver in increased sales for the company in 2014.
Hcp content posted june 24, 20 in aaos 20 and persona knee. Zimmer polar total knee arthroplasty tka full text view. Zmh, a global leader in musculoskeletal health, today introduced persona the personalized knee system, at the 20. This persona knee replacement system is designed restore mobility to restricted or immobile knee joints. It was promoted as a personalized knee with a better custom fit to match each patients unique biomechanics. Zimmer persona metal plate recall lawsuit parker waichman llp. The zimmer persona knee replacement devices are a newer zimmer knee product line which were designed to be longer lasting while mimicking natural action of the knee. Its our most comprehensive system, including more anatomically accurate components with finer increments to help you personalize the fit for each patient and restore the unique identity of every knee. Zimmer polar total knee arthroplasty tka the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Porous femoral components, manufactured by zimmer, inc. The study design is a prospective, multicenter, study of the commercially available persona fixed bearing knee implants. The instruments and technique assist the surgeon in restoring the center of the hip, knee, and ankle to lie. Patients who have had a knee replacement using the persona implant may need further surgery to avoid the risk of product failure or to correct problems caused by the loosening of the implant. Zimmer biomet is the leading company in partial knee arthroplasty pka 2 with over 40 years experience, offering a comprehensive range of anatomic and innovative solutions.
Faqs about zimmer persona knee implants database of. Zimmer recalls persona knee implant in march 2015, zimmer inc. But data now indicates that certain zimmer kneesnamely. These appear to be a further evolution of knee devices, but they remain offtheshelf implants. Jun 24, 20 introducing persona the personalized knee system.
Find zimmer nexgen knee profiler by zimmer circa 2008. Osteoarthritis, traumatic arthritis, polyarthritis, andor severe chondrocalcinosis of the patellofemoral joint. Studies have shown that 15%39% of patients who undergo total knee surgery are not satisfied with the outcome. Two prominent chicago surgeons are calling for a recall on zimmers nexgen knee. Zimmer patient specific instruments supported implant systems.
In 2015, zimmer, maker of the persona personalized knee system, announced it was voluntarily recalling a component in the knee replacement. Zimmer launches a new era in knee replacement with persona. Zimmer biomet announces global launch of the persona. The persona system, built on the worlds most successful knee replacement system, has knee replacement implant sizes in the smallest increments, giving your surgeon the most comprehensive selection to choose fromall in order to best fit you to provide a superior fit and feel. Zimmer biomet announces global launch of the persona partial. Register to receive a free european market report suite for orthopedic large joint devices report synopsis and brochure. A zimmer persona knee recall was announced by the fda on march 12, impacting all lots and sizes of the persona trabecular metal tibial plate used during knee replacement procedures throughout the.