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Defective Knee Implants
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Allegedly defective knee implants have been a cause of concern for medical professionals and patients alike, with some knee implant devices being the subject of recalls due to a high rate of complications, ranging from infection and trauma to loosening or poor implant positioning, along with a defective medical device. Among issues allegedly associated with knee implant failure are debonding of the joints, pain in and around the knee, decreased mobility and range and other problems often leading to revision surgery. Many defective knee implant lawsuits involve metal-on-metal devices.
Consumers Union has called on medical device companies such as Zimmer and Stryker to provide warranties that would cover the cost of replacing defective knee implants directly to those surgeons who perform replacement surgeries. As of February 2014, the policy and advocacy division of Consumer Reports asked that, "Medical device makers should be willing to provide a warranty that spells out how long they will stand by their products and a process for getting it replaced at no cost if the implant turns out to be defective."
About 1.2 million hip and knee surgeries are performed in the US each year and as baby boomers age, up to 4 million implants per year are predicted. Most knee implants are supposed to last from 15-20 years but the failure rate is estimated at 10 percent and often because the knee implant is defective, according to the American Association of Orthopedic Surgeons. Eight percent of knee replacements lead to costly and painful revision surgery.
Consumers Union urged medical device manufacturers, including Biomet, Inc., DePuy Synthes, Smith & Nephew, Stryker Corporation, Wright Medical Technology, Inc, and Zimmer Holdings to provide a warranty to include the following:
Zimmer, maker of the NexGen knee implant, markets the NexGen CR-Flex Fixed Bearing knee in both a cemented and uncemented version (that is, a version that uses an adhesive to connect the thigh bone and the devise and a version that allows the bone and devise to bond via natural bone growth). In both cases, the artificial knee was expected to last patients for at least 15 years, but some surgeons point to an allegedly higher-than-normal rate of failure for the uncemented CR-Flex Porous Femoral component.
Issues with the Zimmer NexGen CR-Flex Porous Femoral component allegedly include loosening of the implant and failure of the knee implant, which could require revision surgery for repair.
Symptoms of loosening of the knee implant include pain and limited mobility in the affected joint. Patients who believe they are having problems with their knee replacement are advised to have a bone scan (rather than an x-ray, which will not show loosening of the knee implant).
Lawsuits have been filed against Zimmer regarding various NexGen Knee implants alleging the NexGen high-flex knee implants are defective and associated with unnecessary injury to patients. As of September, 2013 there are 1,035 cases pending in the Zimmer NexGen knee implant Multidistrict Litigation (MDL 2272, US District Court for the Northern District of Illinois).
In August 2013 a lawsuit filed in Texas Eastern District Court (case no. 5:2013cv00095) claims the Zimmer NexGen knee implant is defective due to loosening. The plaintiff had to undergo revision surgery. A Nevada resident suffered the same complications, underwent revision surgery and filed a defective knee lawsuit (case no. 2:2013cv01975, Nevada District Court).
The Stryker ShapeMatch Cutting Guide is used during total knee replacement surgery to put the replacement components in place and guide the surgeon when marking the bone before the bone is cut. The Stryker ShapeMatch Cutting Guides are single-use devices used with the Triathlon Knee System. They were designed to allow for smaller incisions in the knee and to customize the surgery for each patient's anatomy.
Stryker ShapeMatch Cutting Guide
The Stryker cutting guides involve the use of an MRI prior to surgery so that a three-dimensional model of the knee can be made. The 3D model is used to determine the size and position of the knee implant. Once those are determined, the ShapeMatch technology is used to create a customized guide to aid the surgeon in making incisions and implanting the knee.
There are concerns, however, that the device can be misaligned, causing knee implants to be placed in the wrong position, resulting in joint instability, pain, limited mobility and fractures. The US Food and Drug Administration (FDA) noted when it announced a Class I Urgent Medical Device Recall of the Stryker ShapeMatch that it had received 44 reports of incidents linked to the ShapeMatch.
Zimmer "Gender Solutions" Natural Knee Flex System, Prolong Articular Surface, knee implants were recalled in 2009 due to difficulty inserting the polyethylene into the tibial baseplate. This issue could result in "intraoperative damage to the device," according to the FDA.
Zimmer Natural Knee Implant
In August 2003, the manufacturer of the Oxinium Pro-Fix II and the Oxinium Genesis II recalled the knee replacement products due to issues with the devices bonding properly. This failure reportedly resulted in infection, joint damage and muscle damage.
Smith & Nephew Knee Implants
In March, 2010 the FDA recalled Journey II Uni Tibial Baseplates after Smith & Nephew received complaints about baseplates breaking, which requires revision surgery. The Class II recall affected approximately 40,000 Journey II knee implants.
In January 2014 the Australian Governments Department of Health issued a safety alert, advising consumers and health professionals that Smith & Nephew has issued a hazard alert regarding the femoral implant component of the Journey Bi-Cruciate Stabilised (BCS) knee replacement system. This particular knee replacement system has been recalled by the Australian Therapeutic Goods Administration (TGA).
A federal judge in June 2014 ruled that an Ohio plaintiff could proceed with a DePuy Orthopaedics lawsuit. The woman alleged that defects in the DePuy bone cement product led to a premature revision of her knee replacement. The judge further ruled that the woman can seek punitive damages against DePuy due to a plausible lack of compliance with the manufacturing and labeling requirements for the FDA-approved device.
DePuy Knee Implants
Symptoms of a defective knee implant include pain in the knee, swelling at or near the knee joint, decreased mobility and a change in ability to walk. Some knee implant failures might require revision surgery, in which the replacement device is itself replaced. Revision surgery often comes at great cost and with longer recovery times than the initial surgery because the joints must be resurfaced.
Symptoms of Defective Knee Implant
Lawsuits have been filed against the makers of various knee implant products alleging patients were harmed by devices that were defectively designed, in some cases requiring painful and costly revision surgery. If you have had a revision surgery to replace a knee implant device, you may be eligible to file a lawsuit.
Defective Knee Implant Lawsuits
Defective Knee Implant Legal HelpIf you or a loved one has suffered similar damages or injuries, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.
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After a lifetime of knee pain, I finally had my right knee replaced in 2014. I was very concerned about joint replacement failure, I already went thru a Stryker hip replacement failure.
My surgeon was confident about the Zimmer Persona (cemented version), that would work great for me. Immediately I noticed issues and had extreme pain, and was told that was normal. The pain never got better, my range of motion was not good, I even went thru an MUA three months after the original surgery, but afterwards my knee froze up again, and was very painful to get it past 100 degrees.
At the 3-month post op appointment, my surgeon wasn't concerned about my pain or range of motion. He stated that it may be as good as it was going to get. I didn't see him again until my one year follow-up appointment.
I still had to walk with a cane, and could only put weight on my knee for a few minutes before the pain was unbearable. He It was verified that tibial component was loose. In just over a year I went thru a revision.
I requested my medical records & surgical notes, it stated that the bone cement (no brand) did not adhere to the bone. I had to call the office to find out the brand of bone cement, which was Zimmer.
I have searched for information on bone cement recalls, and contacted several online medical sites trying to find out if there is a recall, but I have not been able to find out anything on Zimmer bone cement, and if there has been any recalls.
12-15 knee replacement and 1-16 second surgery now iwill have to have revision surgery oxinium Genesis 11 and oxxinumprofix 11 by Smith &nephew
I had my knee replaced last year. It is almost like it is worse. It is clicking and popping worse than before the surgery.
In Oct 2014 I had a total knee replacement that used the verilast Legion system ( the one supposed to last 30 years ) I started having issues after just 5 months and naturally the doctor could find nothing wrong with his ( as he put it ) great job on my knee. It would swell grind lock pop and give way almost every day and every time I walked any distance I>E> 500 feet. going up or down stairs it would either lock in position or just give ut causing a fall or me to grab hold of the hand rail to keep myself upright. after numerous trips to my original doctor I contacted the surgeon every doctor I talked to said to call in Salt lake City. He explained to me that he sees this all the time and it is an easy fix just a couple hours of surgery. I had the 2nd surgery. the Dr. removed the pad in between the upper plate and the lower plate and replaced it with a much larger ( 6 mm or 1/4 inch ) pad and found the original pad to be ( as he said ) severely banged up. He refused to say that the original surgeon made a gross mistake or anything but the pad was banged up. this was a whole 358 days after my 1st, surgery ( the knee is supposed to last 30 years pre Smith and Nephew) mine did not last as year before I had to have it revised. The bad part is like many states that put laws in to protect their Dr.s Utah has a review panel for malpractice and ( surprise surprise) they found that I have no Merit to sue the doctor nor the manufacturer for anything. ( they have not ruled that anyone has merit to sue a Dr, or company for the last 12 years that I can find records for this review pane. Their decision is final and there is no appeal Process. So I either find a class action suit and add my name to it or just go on about my business ( as the panel chairman suggested.) does anyone know of a suit against Smith and Nephew for the verilast system ??
I alma sliger-clark had a knee replacement sept,2010, it was never safe I would fall with no warning ,I was almost a recluse for 5 yrs. it was an Exactech knee replacement .I've stayed in contact with the company that made this component ,they have done nothing but ignore me .I could not go shopping,work in my yard,do my house work ,nothing for the fear of falling .
Had a Stryker Triathlon total knee replacement in August 2014. Having major complications that the doctor cannot explain such as popping, clicking and grinding with any movement of knee, unstable, nerve/muscle damage, chronic pain and numbness.
I have the DuPuy knee implant and I had it done in 2011 it's flours years later and I have so many problems from mine.. I wish I never had it done.. I have been looking for someone to help me with it I know mine is on the recall list.. But no one will help me I had the Dr that done the surgery not tell me that he guess he put the wrong side knee in and I had another Dr to tell me that I could be allergic to the metal... I have alot of swelling and pain popping and cracking in the knee I can't walk but for short periods of time.. I can't do anything that I use to be able to do... I want some e to Please listen to what I'm telling someone I can't deal with this anymore
I had a knee replacement in 2010 the knee replacement never worked right it would take me down the knee cap could click in right the knee replacement was always loose .I continued going to the dr .trying to get it right I had to have it completely replaced again this yr. of march 2015.
I hope you don't ignore me the brand of my replacement was EXACTECH
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