DePuy Knee Lawsuit: Devices Involved in Lawsuits
DePuy knee replacement systems are one of the most popular knee replacement systems available on the market. The DePuy Synthes Companies of Johnson & Johnson of make several components for partial knee replacement and revision surgeries, and total knee replacement systems.
People have knee replacement surgery for many reasons, mostly to relieve pain caused by osteoarthritis or other forms of joint pain such as rheumatoid arthritis or psoriatic arthritis. Other causes of debilitating pain are tears in the meniscus or in ligaments. Knee replacement is usually a last-resort procedure, usually stemming from years of constant debilitating pain unable to be managed by medication.
Knee replacement surgery is usually a significant surgery that requires a great deal of post-op pain and recovery. Weeks of physical therapy are often needed because of the surgery, and most people find they require mobility aids for an extended period after the surgery is completed. During a knee replacement surgery, a doctor replaces parts of the knee joint surfaces with metal or plastic components designed to mimic the natural movement of the knee. One of the most common surgeries result in a hospital stay, and the need for knee replacement surgeries is expected to rise significantly. For example, the number of knee replacement surgeries rose 93% between 2001 and 2011.
In the past decade there has been several DePuy knee replacements recommended to patients undergoing knee replacement surgery. DePuy has seen an increase in the sales of many of their orthopaedic products. In 2015, DePuy Synthes made $1.4 billion dollars of the sale of orthopaedic knee replacements, securing DePuy’s position at the forefront of companies manufacturing knee replacements available to consumers in the United States.
However, according to data available from the U.S. Food and Drug Administration, DePuy recalled 277 knee related components or devices within a 10-year time period between 2003 and 2013; 4 recalls were the most serious type possible, a class I recall. Now many of those defective knee replacements are involved in litigation as recipients seek compensation for life altering damages, multiple revision surgeries, and more.
DePuy Attune Knee System Recall
The Attune Knee system was released in 2013 after an extensive 6-year clinical research project conducted by DePuy. The result, the Attune Knee, was supposed to provide a superior level of increased stability and motion in its recipients.
However, as the Attune knee quickly rose in popularity, becoming one of the company’s most popular devices, the frequency of complaints involving the device increased. Most notably involving a piece of the device that could be defragmented and dislodged in its recipients.
Different Kinds of DePuy Knee Implants
Fixed Bearing Knees—now the most popular knee implant in the U.S. These devices have a structural component in the artificial knee that supports friction and weight, and which remains in a fixed position.
Rotating Platform Knees—designed to provide more natural movement. The structural bearing can rotate in the same way as the original knee. Rotating knees models reduce stress and wear on the implant components.
High-Flexion Knees—DePuy’s high flexion technology allows the implant to bend well beyond the range of traditional knee implants. According to DePuy, high knee flexion movement occurs when a person kneels, squats or crosses their legs.
Total Knee Replacements—total knee replacement surgeries involve several implant components to restore function of a severely damaged knee. Surgeons resurface the bones of the femur and the tibia, then attach plastic, ceramic or metal implants. DePuy markets several total knee replacement systems.
Partial Knee Replacements—Surgeons perform partial knee replacement surgery when only one or two parts of the knee are diseased or damaged. Partial knee replacement surgery allows patients to retain more of their original knee.Implant Fixation a Crucial Issue in Failing Devices
There a few different fixation used to connect knee implant components to the bone. When an implant loosens, as some reports indicate involving the ATTUNE knee system, a patient will require revision surgery.
Cemented Fixation—Implants are commonly held in place with fast-curing bone cement.
Cementless Fixation—Implants may be “press-fit” onto bone, which relies on new bone growing into the surface of the implant. These implants are textured or coated so new bone can grow into the surface of the implant.
Hybrid Fixation—In hybrid fixation, the femoral component of an implant is inserted without cement, and the tibial and patellar components are inserted with cement.
DePuy Sythnes Implant Technology
DePuy’s most popular knee replacement products include the Sigma Total Knee System, LCS Knee System and the ATTUNE Knee System. In March 2014, DePuy Synthes announced two new technologies related to their ATTUNE knee system. These included a rotating platform design and the anatomic patella.
DePuy Attune Rotating Platform design should reduce stress and wear on the implant. The rotating platform allows the bearing to rotate as the knee flexes, allowing for more natural motion than traditional dome-style patella components, reducing soft tissue interaction and irritation.
DePuy has developed more than a dozen knee systems, including high-flexion devices that provide a greater range of motion than standard knee implants. DePuy knee implants are manufactured by DePuy Orthopaedics, part of the DePuy Synthes family of companies, owned by Johnson & Johnson. There have been recalls, regular complaints, and lawsuits filed against the medical device company due to personal injuries, lack of testing, and lack of warning about the potential risks of receiving a knee implant.
DePuy Synthes Proximal Femur Defects Cause Early Failure
A new lawsuit indicates that the DePuy Synthes proximal femur plate is defective, leading to catastrophic early failure and repeated refracturing during four months.
Carolyn Rokosz filed the complaint July 19 in the Southern District of Iowa. She indicates that the proximal femoral plate’s defective design caused considerable pain and her femur to refracture two more times, necessitating surgeries, when it failed. She names DePuy Synthes and its parent company, Johnson & Johnson, as defendants in her complaint.
DePuy Synthes Proximal Femur Failure
Following a fall that fractured her femur, she underwent an implantation procedure with the DePuy Synthes femoral plate on May 13, 2016. Two months later, she suffered from considerable leg pain. On July 20, 2016, an x-ray revealed significant hardware failure of the Synthes femoral plate and refracture. On July 22, 2016, her leg “gave out and she fell on her knee,” leading to a fixation surgery to remove and replace the defective femur plate. Less than two months later, she fell again. An x-ray showed that the bone had refractured once again, resulting in further surgery for internal fixation of the femur non-union and removal of the second implant hardware. According to Rokosz’s lawsuit, the manufacturers knew that outcomes like hers were unreasonably likely to occur. However, they actively concealed these significant risks to protect their profits for patients’ health.
“All of the injuries and complications suffered by Ms. Rokosz were caused by the defective design, warnings, construction and unreasonably dangerous character of the DePuy Synthes femoral plate in her May 13, 2016,” Rokosz’s lawsuit states. “Had defendants not concealed the known defects, the early failure rate, the known complications and the unreasonable risks associated with the use of the Synthes femur plate, Ms. Rokosz would not have allowed any Synthes Femur plate to have been implanted in her body.”
Rokosz indicates that she must undergo further medical testing, treatments, medical monitoring, and invasive exploratory surgeries. She also suffered from metallosis, a dangerous form of blood poisoning, due to the defective metal femoral implant.
This is far from the first time that Johnson & Johnson and DePuy have found themselves in hot water over a defective metal implant. The companies are facing multitudes of lawsuits from patients who have suffered horrific injuries when the companies’ defective Attune knee and ASR and Pinnacle hip implants have failed prematurely, often leading to additional risky surgeries and irreparable harm. The companies not only continued to market these products long after learning of their substantial defects, they didn’t even perform human clinical trials before releasing them on the unsuspecting masses.