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 in thousands of patients who underwent a total knee replacement with the DePuy Synthes Attune Knee Replacement System. Reports of loosening and high failure rates in patients around the United States have prompted a closer look at the implants. Patients are beginning to blame DePuy for making a defective product by filing lawsuits in court.
If you or a loved one received a DePuy Knee implant and have experienced loosening, pain, or other symptoms, please contact our DePuy Knee replacement lawyers for a free case consultation.
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, 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 cartilage in joints. Eventually, the 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 a plastic material. A spacer is then inserted between the metal components to provide an easier surface for the material to glide.
DePuy Knee Replacement Side Effects
Patients who report adverse health effects after receiving a DePuy Attune Knee System often experience the following symptoms:
- Instability when placing weight on the affected area
- The knee moving backward or sideways
- Fluid buildup leading to inflammation and swelling
- Chronic pain
- Feeling of heat in the knee that begins several months after surgery
If you have experienced any of these symptoms after undergoing surgery for a DePuy Synthes Attune Knee System, do not hesitate to contact our class action attorneys for a free, no-obligation consultation to discuss filing a DePuy knee replacement lawsuit.
DePuy Attune Knee System History
- 2007 & 2008 – DePuy recalled their P.F.C. knee systems due to a defect in the knee replacement joint that would cause the artificial joints to wear out quickly and break.
- 2009 – The P.F.C. Sigma knee system was recalled over a femoral component that posed severe side effects to patients.
- 2014 – DePuy issued three recalls for three different knee replacement devices. One recall was for 100 S-ROM Noiles hinges over packaging defects and safety concerns related to sterility. Another recall was over a component that was at risk of cracking. The third recall was issued over a component that could fracture and leave parts of the device in a patient.
- 2015 – Thousands of DePuy’s Attune knee systems had to be recalled due to a surgical tool reportedly breaking and leaving fragments inside patients. A wire spring coil in the Attune Knee Tibial Articulation Surface Instruments 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.
- 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.
Components of DePuy Attune System
The DePuy Attune System isn’t just a single device. Instead, it is made up of several components. Here are five major elements, according to DePuy Synthes:
- 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 from a proprietary material marketed as offering excellent wear resistance and long-term stability.
Reports of DePuy Attune Loosening and Failure
Not long after the DePuy Attune Knee System was approved, the FDA began receiving reports of failure in the devices.
This culminated in a widely publicized study published in the Journal of Knee Surgery in September 2017. Researchers examined FDA reports in the Manufacturer and User Facility Device Experience (MAUDE) database related to Attune devices. Hundreds of reports involving the Attune system were found.
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 in just the 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.
DePuy Knee Replacement Recall
So far, there has not been a recall of the Attune system, despite reports of high rates of failure. In 2015, a component of the system was recalled after DePuy found that a wire spring coil in the Attune Knee Tibial Articulation Surface Instruments was prone to damage.
The Class II Device Recall dealt with more than 3,000 units.
DePuy Knee Replacement Lawsuit Filed
Shortly after the release of the study citing loosening in the Attune system, a 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 the 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 a 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 device’s premature failure.
Compensation in a DePuy Knee Replacement Lawsuit
Lawsuits are currently being investigated and filed on behalf of patients who were harmed by defective Attune Knee Replacement devices. The types of compensation that you may have a legal right to seek include:
- Present and future medical expenses
- Lost income and reduced future earning capacity
- Pain and suffering
- Emotional distress
- Loss of quality of life
- Loss of intimacy or “consortium” with loved ones
More lawsuits are expected to be filed against DePuy and Johnson & Johnson related to the Attune Knee Replacement System. Anyone affected by the system is encouraged to contact a qualified attorney to find out more about the next steps.
Looking to File a DePuy Knee Lawsuit?
Those who have been forced to undergo revision surgery after being implanted with the DePuy Knee device can contact the experienced lawyers at The Eichholz Law Firm. Our DePuy Knee lawyers will fight to get you the compensation you deserve.
For a free case evaluation, call (855) 551-1019 or fill out an online contact form.
- 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 January 26, 2021.
- Depuy Synthes. “ATTUNE® Knee System”, Johnson & Johnson, https://www.depuysynthes.com/hcp/knee/products/qs/ATTUNE-Knee-System. Accessed January 26, 2021.
- FDA. “Class 2 Device Recall ATTUNE” Articulation Surface”, U.S. Food and Drug Administration, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137734. Accessed January 26, 2021.
- FDA. “MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ATTUNE BAL SIZER DISTRACTOR KNEE INSTRUMENT/TRIAL”, U.S. Food and Drug Administration, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4259356. Accessed January 26, 2021.
- FDA. “Medical Device Recalls”, U.S. Food and Drug Administration, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&event_id=&productdescriptiontxt=¢erclassificationtypetext=&recallnumber=&postdatefrom=&postdateto=03%2F02%2F2014&productshortreasontxt=&firmlegalnam=DePuy&knumber=&pnumber=&PAGENUM=500. Accessed January 26, 2021.
- FDA. “Medical Device Recalls”, U.S. Food and Drug Administration, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&event_id=&productdescriptiontxt=¢erclassificationtypetext=&recallnumber=&postdatefrom=&postdateto=&productshortreasontxt=&firmlegalnam=DePuy&knumber=&pnumber=&PAGENUM=500. Accessed January 26, 2021.
- FDA. “Summary of Safety and Effectiveness Attune Total Knee DePuy Orthopaedlics”, U.S. Food and Drug Administration, https://www.accessdata.fda.gov/cdrh_docs/pdf10/K101433.pdf. Accessed January 26, 2021.
- Jared R. H. Foran, MD. “Total Knee Replacement”, OrthoInfo, https://orthoinfo.aaos.org/en/treatment/total-knee-replacement/. Accessed January 26, 2021.