The knee is one of the most important joints in the body, allowing people to walk around freely and enjoy life. However, injury or arthritis can cause crippling pain that leaves a person incapacitated.
When the pain becomes too severe, sometimes a total knee replacement is the only option. Since the first knee replacement was performed in 1968, advancements have been made to implant designs and surgical techniques. Unfortunately, unexpected complications are not out of the ordinary.
That’s what happened to thousands of patients who underwent a total knee replacement with the DePuy Synthes Attune Knee Replacement System, according to the FDA. Reports of loosening and high failure rates in patients around the United States have prompted a closer look at the implants.Patients who require revision knee surgery due to the damage caused by the defective knee implant may be eligible to file a defective medical device lawsuit against the manufacturer. To connect with potential plaintiffs, law firms can work with Broughton Partners, a case-generation service and legal marketing company that provides qualified defective knee replacement leads. The leads your law firm will receive are case-ready and have been fully inspected for legitimacy. If your law firm wants to help more victims of defective knee implants, call Broughton Partners today and start receiving more defective hip replacement leads.
Reasons for Knee Replacement Surgery
The Agency for Healthcare Research and Quality reports that more than 600,000 knee replacements are performed every year in the United States alone. Knee replacement, also known as knee arthroplasty, is a procedure done after non-surgical treatments no longer manage the pain.
According to the American Academy of Orthopaedic Surgeons, these are the most common causes of knee pain that require knee replacements:
- Osteoarthritis: As people get older, the cartilage in the knee wears away. This results in bones painfully rubbing against one another.
- Rheumatoid arthritis: This is a disease in which inflammation damages the cartilage in joints. Eventually, inflammation can lead to cartilage loss.
- Post-traumatic arthritis: After knee surgery, damage can occur around the joint and worsen over time.
During knee replacement surgery, cartilage is removed before metal components are added to the surface of the joint. The kneecap is also typically resurfaced with plastic material. A spacer is then inserted between the metal components to provide an easier surface for the material to glide.
Knee and Hip Replacements: Becoming one of the leading causes of medical device recall lawsuits
- The majority of faulty knee and hip replacement products released on the market gained approval through the 510(k) program.
- Metal on metal devices have been proven to have a significantly higher failure rate and cause more severe injuries to patients who have been implanted with them.
- DePuy Orthopaedics— owned by Johnson & Johnson— was forced to recall its Articular Surface Replacement (ASR) XL Acetabular system in 2010 after it was found that approximately 13% of patients who received the device required revision surgery within the next five years. The device utilized metal on metal components.
- Similar devices made of ceramic components last 15 years on average before any complications or problems with the devices arise.
- By March of 2013, DePuy was facing over 14,000 lawsuits due to conditions and injuries caused by the Articular Surface Replacement (ASR) XL Acetabular system.
- DePuy was also forced to recall its LCS Duofix Femoral Component in Australia. The device is a knee prosthetic that was also comprised of metal on metal components and patients reported many of the same complications as the device that patients receiving the Articular Surface Replacement (ASR) XL Acetabular system reported.
- Zimmer Holdings Inc. was also the subject of several high profile recalls of hip and knee implants.
- The Durom Cup— an all metal hip implant— was recalled after it was reported that the device had failed prematurely in 6% of the patients who were implanted with the device. Initially, Zimmer blamed the failures on the “incompetence of the surgeon” implanting the devices.
- By July of 2008, Zimmer recalled the Durom Cup, claiming that the instructions it provided to surgeons implanting the devices were subpar.
- Zimmer’s NexGen CR-Flex knee replacement experienced similar failures and was pulled from the market when 9% of patients implanted with the device reported pain and other severe complications.
- In April of 2012, Stryker Corporation released a statement issuing a recall of its Rejuvenate and ABG II modular-neck hip stem systems, citing safety concerns and recommending that patients contact their surgeons for regular monitoring of potential complications. In many cases, the devices will need to be removed in order to prevent serious or life-threatening complications.
- All metal on metal devices presents the risk of metalosis— which occurs when toxic metals enter the bloodstream. Patients who have received any of these defective products must undergo routine blood monitoring to prevent complications that can arise from metal ions that have entered the body due to the grinding of metal parts against one another.
- In addition to metalosis, patients have reported tissue death, bone decay, intense pain and swelling and tumors at or near the site of the implanted device.
Attune Knee System History
In December 2010, the Attune Knee System was approved by the U.S. Food and Drug Administration under the agency’s 510(k) approval process.
This is a special expedited approval process in which a manufacturer must prove that the device is “substantially equivalent” to a product already on the market legally. According to the FDA, “a claim of substantial equivalence does not mean the new and predicate devices must be identical.” A device must only be equivalent in design, use, and others.
Devices approved under 510(k) do not need to conduct clinical trials or provide evidence of safety before approval.
Orthopaedics said the DePuy Attune Knee System was substantially equivalent to eight other products on the market at the time, such as the Sigma Patella and Zimmer NexGen CR Knee System.
The knee replacement system was originally designed to address the unmet needs of patients around the world. On the Synthes website, the tagline for the system is “A knee that can help patients get back sooner.”
Components of the DePuy Attune System
The DePuy Attune System isn’t just a single device. Instead, it is made up of several components including:
- Attune Gradius Curve: This component is made to work with the femur and tibia. It helps minimize unnatural sliding.
- Glideright Articulation: This aspect deals with the interaction between the kneecap and the femur.
- Sofcam Contact: The Sofcam component helps stabilize the knee when walking.
- Logiclock Tibial Base: This component is attached to the tibia and is essential for stability. It comes in different sizes and offerings to match the femoral size.
- AOX Polyethylene Insert: The spacer is made of proprietary material marketed as offering excellent wear resistance and long-term stability.
Reasons for a Knee Replacement or Knee Revision Lawsuit:
- Loosening or fracture of the implanted knee device
- Chronic swelling and pain even months after the initial surgery
- Instability or stiffness resulting in difficulty walking
- Post fracture, breakage, or premature wear of the polyethylene components
- Weakening of the bones around the implant, also known as osteolysis
- Deep joint or periprosthetic injection requiring follow up surgery
- Poor wound healing
- Reduced range in motion or stiffness in the knee
- Blood clots
- Bone fracture during surgery
- Damage to nerves or blood vessels
- Manufacturers have a responsibility to produce safe and reliable products that are realistically marketed to meet consumers’ expectations. When a medical device manufacturer knowingly sells a knee implant that can result in premature failure, frequent pain or additional surgeries, the manufacturer should be held liable.
Many Knee Replacement Manufacturers Are Dealing With Lawsuits
Zimmer is not the only company facing civil action because of its faulty knee replacement devices. A DePuy Attune Knee, which has a five-year failure rate of nearly 68 percent, is also the target of several investigations. Other companies have issued recalls on many of their devices, too, and are facing multiple insurance claims and civil lawsuits. While all jurisdictions and cases are different, knee replacement failures have seen plaintiffs receive upwards of $50k plus medical expenses. Some have been reported into the millions of dollars for pain and suffering alone. A few of these manufacturers include:
- Exactech’s Optetrack Knee
- Stryker’s Scorpio CR and PS components, Unicompartmental Knee System, and Duracon Total Knee
- Smith & Nephew’s Oxinium Genesis II, Profix II, and Journey Uni Tibial Baseplate components
- Biomet’s Vanguard CR.
- We must also tell you that many of these companies who are having difficulty with their artificial knees are experiencing similar problems (and civil injury lawsuits) with their hip replacement systems — and for the same reasons.
Reports of Attune Loosening and Failure
Not long after this culminated in a widely publicized study published in the Journal of Knee Surgery in September 2017. Researchers examined FDA reports on the Manufacturer and User Facility Device Experience (MAUDE) database related to Attune devices. Hundreds of reports involving the Attune system were found. The Attune Knee System was approved and the FDA began receiving reports of failure in the devices.
After looking through the evidence, the researchers said they had “encountered a high rate of debonding of tibial implant–cement interface.”
In an examination of three hospital databases, researchers found 15 cases of tibial loosening in the Attune system. They also found 21 reports of tibial loosening in the MAUDE database just two months before the study concluded.
A response to the study was also published in the journal by Michael A. Mont of the Department of Orthopaedics at the Cleveland Clinic. Mont warned that the scope of the issue was not yet known and further investigation into the matter was warranted.
History of Knee Replacement Recalls
In both 2007 and 2008, DePuy was ordered to issue recalls on their P.F.C. knee systems. The recall was issued due to a defect in the knee replacement joint that would cause the artificial joints to quickly wear out and eventually break.
In 2009, the P.F.C. Sigma knee system was forced to recall over a femoral component that could cause severe side effects to patients.
In 2014, DePuy issued three recalls for three different knee replacement devices. The first recall was issued for the 100 S-ROM Noiles hinges due to packaging defects and safety concerns related to sterility. Later in 2014, DePuy’s Attune Intuition knee system issued two recalls for one component that had a high risk of cracking and another component that could fracture and leave parts of the device in a patient.
In 2015, thousands of DePuy’s Attune knee systems had to be pulled off the market due to a surgical tool that was reportedly breaking and leaving pieces inside patients’ surgical sites. There was a wire spring coil in the Attune Knee Tibial Articulation Surface Instruments that was prone to damage. Doctors were unaware that this component was breaking and thousands of patients were at risk of complications. The Class II Device Recall dealt with more than 3,000 units.
In 2017, DePuy was forced to recall their Sigma HP PFJ cemented trochlear implant. This component caused a high rate of knee replacement revision surgery. Patients have reported that these defective parts may become dislocated and misaligned.
Lawsuits After Primary and Revision Total Knee Arthroplasty: A Malpractice Claims Study Analysis
As the number of total knee arthroplasties (TKAs) increases, the number of associated complications will also increase. A study by The National Center for Biotechnology Information identified common causes of and financial trends relating to malpractice claims filed after TKA.
The study identified 69 primary and 8 revision TKAs in the malpractice carrier’s database. All cases were performed between 1982 and 2012; all claims were closed between 1989-2015. The most frequent factor leading to lawsuits for primary TKA was chronic pain or dissatisfaction in 12 cases, followed by nerve palsy in 8, postoperative in-hospital falls in 5, and deep vein thrombosis or pulmonary embolism in 3. Medical complications included acute respiratory distress syndrome, cardiac arrest, and decubitus ulcers. Contracture was most common after revision TKA (three of eight cases). Mean indemnity was $325,369, and the largest single settlement was $2.42 million. The average expense relating to the defense of these cases was $66,365.
Orthopedic surgeons should continue to focus attention on the prevention of complications and on preoperative patient education. Preoperative counsel regarding the risks of incomplete pain relief could substantially reduce the number of suits relating to primary TKAs.
Faulty Knee Replacement Lawsuits
In response to the complications suffered by many knee replacement recipients, lawsuits have been filed against joint replacement device manufacturers.
One case we’re familiar with was filed by a woman after she received a Zimmer Biomet NexGen knee device in 2009. Within two years she began suffering painful complications and needed revision surgery. During the procedure, she then suffered intraoperative bleeding. This forced her to transfer to another hospital for yet another operation – one that never would have been needed had her original artificial knee worked as promised
Often, multiple replacement procedures – accompanied by painful recovery – are necessary to correct an original knee replacement surgery. Hundreds of injured plaintiffs have filed lawsuits claiming their devices did not work as promised. So far, well over 600 such civil suits have been filed against NexGen manufacturer Zimmer, seeking compensation for medical expenses, rehabilitation, home health care, loss of income, pain, suffering, and temporary or permanent disability.
Zimmer was also the defendant in a lawsuit filed by the Securities & Exchange Commission, which alleged the company bribed surgeons with paid consulting agreements to use their products. Zimmer had to pay almost $170 million to settle those charges.
Lawsuits Filed Against Knee Replacement Manufacturers
Manufacturers claim that the average lifespan for knee replacement systems is approximately 15 years. However, many patients report premature device failure between two and five years after implantation, according to the Academy of Orthopaedic Surgeons.
In response to serious complications from defective knee implants, many patients have filed knee replacement lawsuits against manufacturers of the devices. Generally, these lawsuits claim the device’s manufacturer failed to properly design, manufacture or market its device. In many cases, victims alleged the manufacturer neglected to make sure the knee replacement device was safe and would perform the way the manufacturer claimed it would.
Common knee replacement devices and manufacturers:
- DePuy Synthes Attune© Knee System
- Zimmer© NexGen© CR-Flex
- Biomet Vanguard© CR
- Smith & Nephew Journey BCS©, Oxinium Genesis II©, Profix II©, Journey Uni Tibial©
- Stryker Triathlon© Total Knee System, Scorpio CR© and PS© components, Unicompartmental Knee System, Duracon© Total Knee
Attune Knee System Lawsuit
Shortly after the release of the study citing loosening in the Attune system, a law firm filed the first lawsuit against DePuy Synthes over claims that the device prematurely failed. The lawsuit was filed in September 2017 in the Circuit Court of Tuscaloosa County by Cunningham Bounds LLC. The lawsuit alleges that Johnson & Johnson and its subsidiary DePuy Synthes created a defective device. The firm cited the study in the Journal of Knee Surgery as evidence of high failure rates.
“In most cases, the only medical solution for patients who experience a premature failure of their Attune Knee System is to undergo revision surgery to remove the implant and replace it,” the firm wrote in a press release. “These revision surgeries are often more painful and invasive than the initial replacement surgery.”
Thousands of patients have already been implanted with the Attune device. Some have had to undergo complicated revision surgery to correct the premature failure of the device.
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- FDA. “Class 2 Device Recall ATTUNE” Articulation Surface”, U.S. Department of Health & Human Services, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137734. Accessed April 4, 2019.
- FDA. “MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ATTUNE BAL SIZER DISTRACTOR KNEE INSTRUMENT/TRIAL”, U.S. Department of Health & Human Services, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4259356. Accessed April 4, 2019.
- Depuy Synthes. “ATTUNE® Knee System”, Johnson & Johnson, https://www.depuysynthes.com/hcp/knee/products/qs/ATTUNE-Knee-System. Accessed April 4, 2019.
- FDA. “Summary of Safety and Effectiveness Attune Total Knee DePuy Orthopaedlics”, U.S. Department of Health & Human Services, https://www.accessdata.fda.gov/cdrh_docs/pdf10/K101433.pdf. Accessed April 4, 2019.
- Jared R. H. Foran, MD. “Total Knee Replacement”, OrthoInfo, https://orthoinfo.aaos.org/en/treatment/total-knee-replacement/. Accessed April 4, 2019.
- Eric Peters. “Patient-surgeon consensus needed in determining candidates for knee replacement surgery”, https://www.news.vcu.edu/article/Patientsurgeon_consensus_needed_in_determining_candidates_for. Accessed April 4, 2019.
- The Journal of the American Academy of Orthopaedic Surgeons, Authors: Patterson DC1, Grelsamer R, Bronson MJ, Moucha CS, From the Department of Orthopaedic Surgery, Mount Sinai Health System, New York, NY, “Lawsuits After Primary and Revision Total Knee Arthroplasty: A Malpractice Claims Analysis”