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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.



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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."

cipro4articleAbout 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:
  • Covers the full cost of replacing the flawed device, including the device, surgeon and hospital costs as well as related patient out-of-pocket costs.
  • Establishes a clear system for patients to use, including a toll-free phone line and a registration number to track the claims process, with physicians charging the device company, not the patient.
  • Does not eliminate the patient' right to sue if they use a warranty.
  • Provides the patient with a full explanation if a warranty claim is denied and an appeals process for denials.
  • Does not disqualify patients across the board if they have specific diseases or illnesses that are not related to the failure of the device.

Zimmer NexGen

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).
 

Stryker ShapeMatch Cutting Guide

hipreplacementsurgeryknee 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.

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 Natural Knee Implant

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.
 

Smith & Nephew Knee Implants

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.

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 Government' 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).
 

DePuy Knee Implants

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.
 

Symptoms of Defective Knee Implant

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.
 

Defective Knee Implant Lawsuits

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 Legal Help

If you or a loved one has suffered damages or injuries from a Defective Knee Implant, please click the link below and your complaint will be sent to a Medical Device lawyer who may evaluate your claim at no cost or obligation.

 


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DEFECTIVE KNEE IMPLANT LAWSUITS


DEFECTIVE KNEE IMPLANT LEGAL ARTICLES AND INTERVIEWS

Tentative Settlement Reached in Zimmer NexGen Knee-Implant MDL
Tentative Settlement Reached in Zimmer NexGen Knee-Implant MDL
February 15, 2018
Los Angeles, CA: Zimmer, the maker of NexGen knee replacements and the defendant in a defective products multi-district litigation (MDL) has reached a preliminary settlement with the plaintiffs in the longstanding MDL. READ MORE

DePuy Faces Yet Another Lawsuit Concerning its Attune Knee Replacement System
DePuy Faces Yet Another Lawsuit Concerning its Attune Knee Replacement System
January 28, 2018
Jackson, MI: Whenever an individual files a defective knee implant lawsuit, the focus is normally – and correctly – on the failed component due to an alleged design, or manufacturing defect. But a companion issue just as devastating as the failure of the implant is, for the patient, a requirement for revision surgery to eradicate the problematic implant and replace it with another one. Revision surgery is usually, a more complex procedure. READ MORE

Tracking Systems in the U.K Key to Care for Hip Implant Patients, But Non-Existent in the U.S.
Tracking Systems in the U.K Key to Care for Hip Implant Patients, But Non-Existent in the U.S.
January 26, 2018
Santa Cruz, CA:The study, published in the Bone & Joint Journal, finds that the rate of metal-on-metal (MoM) hip implant patients undergoing revision has increased over time. Researchers at the Universities of Oxford and Bristol have suggested the observed differences are in part due to increased patient surveillance. In the U.S., patient surveillance is pretty much left up to the patient. READ MORE

READER COMMENTS

Posted by

on
science has failed on knee replacement implants patients are human beings that need corporations to fulfill competent designs for safety and durability my experience with surgeons so far has been chaos this is not something new knee replacement has been around forever i cannot have this surgery because of all the lawsuits where are the minds that create and design perfection people needing this surgery are also victims of this corruption surgeons are putting these deflective implants in people deflective implants are the new normal corporations surgeons FDA have all failed to do their work my research has made me lose hope lose my capacity to live my life fully quality of life is leaving me fast I was an extr0dinary person who loved life and lived with purpose all over the world if there is any hope for success with these implants let me know regrets are an awful way to live and to deal with death sorry is not good enough making this right is the only proper way for all involved thanks DAM

Posted by

on
I had separate total knee replacements in 2013. Because I was not walked until 15 hours had passed after the second surgery, I developed blood clots and almost died. I begged not to be sent home and returned within an hour or two. (Surgery was delayed, and physical therapy closed. Regular nurses refused to walk me because they did not have an order.) In July 2021, I learned that blood clot scars had caused pulmonary fibrosis, which I am now battling! In addition, I developed lymphedema and entered stage 3 before learning about my condition. Now, nothing can be done to relieve pain and swelling except for manual drainage, compression hose and night garments that cost $2,500.00. Insurance does not pay for garments. Originally, my doctor said I had no problem—all would be well. Swelling and popping were normal, Last Fall I discovered that both knees were loose, due to pads that were completely flat. After my pulmonary fibrosis is under control, I must have surgery on both knees to replace pads—6 months recovery time. My life has been miserable since having knee replacement nine years ago. I walk with a cane and sometimes use a walker. Pain and swelling continue, and a piercing pain now radiates throughout my knees. Are these common occurrences? I recently requested and received copies of replacement devices (not given to me after surgeries) and was told that notifications of recalls sometimes fall “between the cracks.” Is this true? How do I learn if my pads were recalls? Do I have any recourse? Will my pain ever stop? Will I walk more effectively after new pads have been inserted? I was sold a compression pump but have been told it can be dangerous to use. Is this true? Where can I obtain consistent answers? Experiencing constant pain in Tennessee!

Posted by

on
I have read comments on the defective DePuy Attune knee replacement and they don’t begin to tell the full story of all the pain and loss of ability to have a good life due to the horrible pain and medical help one has to receive after the use of this device. I have now have had four knee surgeries, the first two were the defective DePuy Attune which had to be replaced less than two years after the original surgery. The next two were full revision surgeries taking twice the surgical time and recovery time and leaving me in permanent pain and only able to spend time off my legs that both hurt like a tooth ache and no relief from the pain due to allergic reaction to all pain meds. Not only that but now on blood thinners due to clotting caused from surgeries and will be on it for life. This story does not even begin to paint a picture of all I have been through that began with the first implant six years ago. I had enjoyed a full and busy life until the DePuy Attune took it away from me.

Posted by

on
I was just wondering if anyone has got any settlements yet. I had a Stryker knee implant and the post came loose just 3 months after my surgery! Most excruciating pain I ever had! I have already retained an attorney.

Posted by

on
I have pain my knee was replaced in 2016 my knee clicks it an swells I have a burning pain they said it is ok bullshit they put a 800 hundred buck brece on my knee

Posted by

on
Top this.... 1st knee replacement with a DePuy (recalled). 2nd total knee revision done with a Stryker TS Poly (recalled). 3rd knee surgery for infection, plastic parts replaced and size changed. Since that change my patella has dislocated and now "they" can only suggest full fusion and/or amputation. Good Doctors? How about UC Davis and Stanford? Does anyone even care?

Posted by

on
I also have a Smith and nephew oxinium implant knee. The hardware is junk
Never stopped hurting , swelling , barley walking.. bastard orthopedic admitted nothing , won't even admit it's a problem .radiologist. said knee looks like extreme trauma , shave you been in car crash ? No I have not ,just bad hardware ,and horrible doctor

Posted by

on
Knee replaced in 2012, and never stopped swelling and hurting. Dr was a jerk and says nothing wrong. Stryker knee

Posted by

on
I have a total knee replacement in April19,2017..i been having pain recently I went to have an xray and result was a loosening in my upper implant.

Posted by

on
I HAD A TOTAL KNEE REPLACEMENT IN JUN. 2016 IT WAS A STRYKER AND THE DR. HAD TO GO IN AGAIN 2ND TIME AND A 3RD TIME AFTER THAT HE HAD ME TO SEE ANOTHER DR. HE DID A CULTURE AND FOUND OUT I HAD A BAD INFECTION AND HAD TO HAVE A REVISION SURGERY DONE WITH ANTIBIOTIC SPACER ADDED IN MY KNEE ,THAT TOOK 3 MONTHS ON IV ANTIBIOTICS AND AT NURSING FACILITY, . IN NOV 2016 I HAD THE SPACER REMOVED AND ANOTHER KNEE REPLACEMENT PUT IN AND I STILL CAN NOT WALK CORRECTLY AND ITS BEEN ALMOST 2 YEARS. SOMETHING IS NOT RIGHT. THE DR. TOLD ME IF I WAS NOT ANY BETTER FROM DEC 2016 TO JAN 2018 MY LAST APPT. I WAS GONNA GET ANY BETTER

Posted by

on
I had my knee replacement in nov. 2015 , have had nothing but problems. In PT I was told it will get better. Pt ended still pain. Went back to work in Jan.2016 still with pain and stiffness swelling.. and knee is always clicking. Los my job in February because it was to much on my knee. I had to stand for 8 hours a day 5 days a week. This was to much on my knee. When I walk my knee clicks outward and is very noticeable. I can’t walk long it swells up and becomes very stiff.. if I sit in a kitchen type chair for more then 5 minutes, when I get up it is stiff. When I also walk it has given out on me. I fell down my steps due to it giving out.. my device is Stryker Triathlon system.

Posted by

on
STRYKER KNEE REPLACEMENT 12-30-2017 WAS A PROBLEM DAY ONE KNEE ALWAYS COLLASPED NUMEROUS TIMES SEVERE PAIN FOR 10 MO. I HAD SEVERAL FALLS, BACK RIB DISLOCATED AND FRACTURED WRIST NOW. KNEE GRINDS & POPS WHEN WALKING. NOT SATISFIED DR REFUSES RT KNEE REPLACEMENT AGAIN. FUNNY HE SWITCHED TO DEPUY. HE THINKS PT AGAIN WILL FIX IT AN IT WILL NOT STOP MALFUNCTIONING MY BALANCE IS UNEVEN KNEE IMPLANT MAKES MY LEFT LEG SHORTER. THE NERVE DAMAGE WILL NEVER GO AWAY.

Posted by

on
I had a total knee replacement surgery in 2007 the manufacture is Smith and NephewOxinium technology. In 2009 started having constant pain swelling and instability which caused me to fall and therefore incur other injuries and embarrassment. I eventually had knee replacement surgery in 2016 Any information on what I can do now would be helpful

Posted by

on
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.

Posted by

on
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

Posted by

on
I had my knee replaced last year. It is almost like it is worse. It is clicking and popping worse than before the surgery.

Posted by

on
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 ??

Posted by

on
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 .

Posted by

on
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.

Posted by

on
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

Posted by

on
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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