maude adverse event report: microport orthopedics inc. evolution(tm) mp tibial base knee component MicroPort Orthopaedics has voluntarily recalled one of the components in its ADVANCE knee replacement system, according to Lexology. Unity Knee is clinically proven 1 with a strong correlation to patient satisfaction 2.Soft tissues are balanced to drive knee kinematics using modern surgical principles either manually or with the OMNIBotics™ robotic platform. MicroPort is a global medical device developer and manufacturer that is headquartered in Shanghai, China.It designs and produces products for a range of medical fields including cardiology, interventional radiology, orthopedics, electrophysiology, and surgical management. The recall has been in effect since August 7th. More articles on devices:Medtronic stock receives target price of $87.83: 3 pointsInVivo Therapeutics adds Ben Taub Hospital as INSPIRE study site: 4 things to knowZimmer Biomet jumps into robotics with MedTech acquisition: 5 things to know. A manufacturer may voluntarily recall a product when evidence is showing that it may be harmful to patients. MicroPort Orthopaedics have issued a voluntary recall on one of the components used in their ADVANCE® knee replacement system. A stemmed primary for both the femur and tibia, and a revision portfolio featuring a CCK with medial-pivot articulation. Here are four takeaways: 1. Knee Replacement Recalls. The manufacturer of the implant, MicroPort® Orthopedics, began noticing a large number of reported fractures of the Profemur Neck Varus/Valgus CoCR (Part #PHAC1254), made from June 15, 2009 to July 22, 2015. The recalled product is the PROFEMUR Long Cobalt Chrome 8 Degree Varus/Valgus Modular Neck, Part 1254. MicroPort Orthopedics Launches Evolution Stemmed CS Knee. 2. By the time everything is said and done, J&J will probably pay more than $4 billion to resolve its implant cases, Carl Tobias, a product-liability law professor at Virginia's University of Richmond, said at the time. The Evolution ® medial-pivot knee system addresses the limitations of traditional designs and today’s patient needs by delivering superior flexion stability, anatomic motion, and wear-limiting design characteristics through three primary knee options. exclude terms. 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The reason for the recall was "higher than expected revision rate due to component loosening," according to the report. MicroPort informed distributors and hospitals about the recall on August 7. © 2021 Questex LLC. MicroPort Orthopaedics is an orthopedic device company focusing on solutions for hip and knee replacements. The MicroPort Profemur Modular-Neck Hip Implant System is a modular hip replacement designed to be used in minimally-invasive surgery. Interested in LINKING to or REPRINTING this content? Choosing the Right Pre-Clinical Collaborative Research Organization (CRO). MicroPort Orthopaedics have issued a voluntary recall on one of the components used in their ADVANCE® knee replacement system. MicroPort began manufacturing the Profemur Modular-Neck System in 2013, after it obtained the franchise as part of it acquisition of Wright Medical Group’s OrthoRecon business. FDA slaps most serious label on MicroPort hip implant device recall. MicroPort Orthopaedics has voluntarily recalled one of the components in its ADVANCE knee replacement system, according to Lexology. According to the agency's database, there were nearly 1,300 recalls on knee replacement systems or components between 2003 and 2019. The FDA said that in August, MicroPort sent a letter to distributors and hospital staff that it would voluntarily recall the devices. All these devices have recalls for a variety of reasons and some of them are to do with simple things like packaging flaws or errors. These recalls have involved 6 manufacturers; most have been class II recalls (with class I being the most and class III being the least serious). Reproduction in whole or part is prohibited. The recall is designated as Class I, meaning the use of the product has a reasonable probability of serious adverse health consequences or death. 1. Written By: MicroPort Orthopedics Built on a 20 year, clinically-established heritage of patient satisfaction and survivorship. Taking that all into account, the agency is slapping the recall with a Class I`, which it usually reserves for problems with devices that could result in serious injury or death. 21 July 2016. In June, U.K. orthopedics giant Smith & Nephew ($SNN) said it would pull some hip implant sizes and related components from the market after data from the U.K.'s cost-effectiveness watchdog found that smaller sizes of the system had higher revision rates than expected. Posted by: Hood National Law Group, in: Defective Products. In February, device magnate Johnson & Johnson ($JNJ) said it would add $420 million to its $2.5 billion legal stockpile to resolve claims over recalled hip implants. Use a + to require a term in results and - to All Rights Reserved. The FDA announced a Class I Recall — the most serious type of recall — on yet another hip implant device. Past recalls have centered on devices that do not bond with the bone correctly or were manufactured differently than required specifications. Copyright © 2021 Becker's Healthcare. 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According to the FDA alert, MicroPort Orthopedics received “reports of an unexpected rate of fractures after surgery related to” its PROFEMUR Long Cobalt Chrome 8 … 2. Enclose phrases in quotes. 1-7 The three options offered are: Cruciate-Substituting (CS), Cruciate-Retaining (CR), and Posterior Stabilized (PS). MicroPort Profemur Recall. What To Do If You Suffered Complications Due To This Hip Implant Unity Knee, developed by a global team of designer surgeons, incorporates implant and instrument designs focusing on MCL isometry and medial joint line … The reason for the recall was "higher than expected revision rate due to component loosening," according to the report. Catalog Number EIS4-P10L: Device Problem Noise, Audible (3273): Patient Problems Pain (1994); Loss of Range of Motion (2032): Event Date 02/27/2013: Event Type Injury : Manufacturer Narrative This is the same event as 3010536692-2015-01940 , -01941 -01943. 3. MicroPort Uses Cookies. The Evolution® NitrX™ medial-pivot knee features a titanium niobium nitride (TiNbN) coating that has been shown to reduce the release of cobalt (Co), chromium (Cr), nickel (Ni), and molybdenum (Mb) ions common in standard CoCr implants. The Evolution Revision Tibial System allows for this flexibility by offering surgeons a range of options including modular keels, augments, multiple stems, offset adapters, and more.” “In addition to its EVOLUTION Revision Tibial System, MicroPort Orthopedics also announced the launch of its EVOLUTION BioFoam Tibia,” says the news release. The company asked healthcare professionals to review the notice, locate all the product mentioned in the letter, stop using or distributing the devices and return the recalled product to its Arlington, TX-based distribution center. On October 2, 2015, the U.S. Food and Drug Administration (FDA) posted a Safety Alert regarding the MicroPort Profemur hip recall. The FDA has announced a Class I Recall for the modular neck component of a hip joint replacement system made by Shanghai, China-based MicroPort Orthopedics. The Shanghai-based company's MicroPort Orthopedics' Profemur Long Cobalt Chrome 8 Degree Varus/Valgus Modular Neck devices, which replace damaged portions of … The U.S. Food and Drug Administration keeps a recall database for medical devices. The Shanghai-based company's MicroPort Orthopedics' Profemur Long Cobalt Chrome 8 Degree Varus/Valgus Modular Neck devices, which replace damaged portions of the hip joint during surgery, could fracture following a procedure and cause symptoms such as sudden pain, instability and difficulty walking, the FDA said in a statement. MicroPort Orthopedics provides a full Evolution® medial-pivot contiuum of care, offering a primary knee with both cemented and cementless options. All rights reserved. The component being recalled is the ADVANCE HA Coated Tibial Bases. 4. View our policies here. Learn about the key factors that are essential to creating a collaborative and productive working relationship to advance pre-clinical drug discovery programs. EVOLUTION® BIOFOAM® Tibial System Traditional 510(k) Tab 006: 510(k) Summary of Safety and Effectiveness 006-1 MicroPort Orthopedics Inc. 5677 Airline Road Arlington, TN 38002 ortho.microport.com 510(k) Summary of Safety and Effectiveness In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Recall of EVOLUTION MP TOTAL KNEE SYS - TIBIAL BASE KEELED NON-POROUS STANDARD COCR According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MICROPORT ORTHOPEDICS LTD. MicroPort is not the only company dealing with hip implant-related woes. A new study has pitted customized knee implants against off-the-shelf implants. View our policies by, Becker's 2021 Enterprise Imaging Virtual Event, Becker's 2021 Orthopedic, Spine + ASC Virtual Event, Becker's 2021 Physician Leadership Virtual Forum, Becker's 2021 April DSO + Dental Virtual Forum, Becker's 2021 Emergency Medicine Virtual Forum, Becker's 2021 Data and Innovation Virtual Event, Becker's 2021 Nursing Leadership Virtual Forum, Becker's June 2021 Women’s + Diversity Leadership Virtual Forum, Becker's June 2021 Health IT + Revenue Cycle Management Virtual Forum, Spine surgeon gets 10-year prison sentence for healthcare fraud, 'Dr. Medical devices like knee replacement products can generally be recalled in three different ways. The parts were manufactured from June 15, 2009 to July 22, 2015, and distributed … 3 Speen Street, Suite 300, Framingham, MA 01701. At the heart of many artificial knee lawsuits are design or manufacturing problems. MicroPort® uses its own and third-party technical, personalization and analysis cookies which under no circumstance process personal data but do capture browsing habits for statistical purposes. The company is asking physicians continue their usual follow-up processes and also inform patients of symptoms that could lead to revision surgery. Subscribe to FierceBiotech to get industry news and updates delivered to your inbox. For this reason, when entering our website we request your consent to use same. 3. China's MicroPort earned the FDA's most serious designation over a recall of devices used in hip joint replacement surgery after reports surfaced that showed the products could be endangering patients' lives. accessgudid - evolution (m684etpkn3sl1)- evolution® mp tib keeled nonpor size 3 standard left The recall affects all lots of the PROFEMUR Long Cobalt Chrome 8 Degree Varus/Valgus Modular Neck, Part 1254. In the present recall, the modular neck known as the PROFEMUR Neck Varus/Valgus CoCR, part number PHAC1254 is the specific part being voluntarily recalled by MicroPort due to high failure rates and resulting safety issues with the implant. MicroPort’s Evolution®Medial Pivot Total Knee Replacement is designed to recreate natural motion and maintain better stability than traditional knee replacements by: Recreating the function and feeling of a healthy knee 2, 3; Resisting uncomfortable shifting and sliding; Increasing control throughout a … MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION (R) CS/CR FEMORAL HOLDER/DRIVER KNEE INSTRUMENT. But the company doesn't expect the move to impact its 2015 guidance, it said at the time, as the products only comprised about 1% of its global hip implant revenue in 2014. Meanwhile, patients with the devices should continue to follow-up with their doctors as prescribed by their surgeon, and should seek treatment immediately if they experience any sudden onset of severe hip pain, difficulty walking, trauma to the hip or leg, or tingling or loss of feeling in their leg, the FDA said in its notice. Knee Replacement Recall Process and Causes. By continuing to browse or by clicking “Accept All Cookies,” you agree to the storing of first- and third-party cookies on your device to enhance your experience, analyze site … The component being recalled is the ADVANCE HA Coated Tibial Bases. For instance, I found one dated June 2016 which was a voluntary recall due to "Profemur(R) neck, Item Number PHA01222 (Short AR VV2 Ti Neck) was labeled as Item Item Number PHA01212 (Short AR VV1 Ti Neck). The resulting paper, “In Vivo Tibial Fit and Rotational Analysis of a Customized, Patient-Specific TKA versus Off-the-Shelf TKA,” appears in the May 25, 2018 edition of the Journal of Knee Surgery. The manufacturer has recalled all lots of their ADVANCE® HA Coated Tibial Bases due to a higher than expected revision rate due to component loosening. The recall includes 10,825 modular-neck components known as the Profemur Neck Varus/Valgus CoCR Part 1254, made from June 15, 2009 to … Interested in linking to or reprinting our content? The manufacturer has recalled all … MicroPort Profemur Hip Recall. The affected lots of the modular neck were manufactured and distributed from mid-June 2015 to the end of July 2015. Recalls are extremely rare. On October 2nd, 2015, MicroPort Orthopedics issued a Class I recall for thousands of hip implant parts that can potentially fracture and lead to serious complications. 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