DePuy, a leading maker of knee and hip replacement systems, has faced more recalls for knee components and systems than any other manufacturer of artificial knees. The company has several lines of knee systems and parts, designed for different patient needs, for revision surgeries, for partial replacements, and for total replacements.
The company touts its innovative and advanced knee systems that are updated regularly with new designs and materials, but it also has high revision rates for its products and has issued many recalls because of defects and harm caused to patients. If you have had a knee replacement surgery with any DePuy product, talk to your doctor about the potential risks and any recalls that may pertain to you. You may also want to contact a lawyer to help you decide if DePuy is liable for any harm you have suffered.
DePuy Knee Replacement Systems
DePuy Synthes, often referred to just as DePuy, is a major subsidiary of Johnson & Johnson. It is one of the largest manufacturers of hip and knee replacement systems, medical devices used to replace part or all of damaged hip or knee joints. The company makes components for partial knee joints, complete joint systems, and revision systems, which are used to replace older, worn or dysfunctional artificial knee joints. DePuy’s knee replacement products include:
- Attune. The Attune line of knee systems includes the company’s latest and most advanced complete artificial joints. It includes a revision system. The design of the knee system is supposed to provide greater mobility and stability with a rotating platform. Attune knees are made of metal and plastic parts.
- Sigma. Sigma is also a line of complete knee joints and revision systems. It was developed from an earlier product, the P.F.C. Total Knee System. It includes knees that have fixed bearings and those with mobile bearings. The Sigma systems are supposed to give surgeons a range of choices for many individual needs. The Sigma line also includes a partial knee system for patients who do not need a complete system.
- LCS Complete. The LCS Complete is a knee system that uses an artificial patella, or kneecap, instead of a rotating platform or bearing, but does have a newer version with a rotational bearing. It includes both metal and plastic components and was designed to be used for patients with arthritis.
- S-ROM Noiles. This complete knee system, which can be used for revisions as well, uses a hinge and rotation design. It is intended for use in patients with instability in soft tissues or with deficiencies or damage in the surrounding bone.
DePuy Recalls Before 2015
Recent recalls of DePuy knee systems and components have made the news in the last two years, especially as victims of the harm caused by these systems have begun to file lawsuits against Johnson & Johnson. However, the company has faced many more recalls before these most recent issues occurred.
In 2007, for instance, one of the company’s P.F.C. knee systems was recalled because of a poor seal on an inner component. This allowed oxygen to enter the joint, which over time would lead to damage. In 2009 the P.F.C. Sigma knee included a femoral component that was found to have cracks in some of the systems. Several lot numbers had to be recalled.
In 2014 a recall was issued for over 100 S-ROM Noiles hinge systems because of defective packaging and potential issues with sterility. Later that year two big recalls were issued for components of the Attune Intuition knee. One part was susceptible to cracking. Another alert, which led to nearly 8,000 parts being recalled, was issued because of disturbing reports of fractures in knees that left pieces of the system in patients.
DePuy Attune Recall
In 2015 a much bigger recall of Attune knee systems eclipsed all of these earlier issues, resulting in thousands of systems and components being taken off the market. A recall was issued in July of 2015 for a surgical tool used with the Attune system. It had been found to break apart in some cases, while in use, with the potential to leave part of the tool in the patient’s body. If the surgeon does not notice this has happened, the patient may later suffer from pain, inflammation, tissue damage, and knee system failure.
DePuy Revision Rates and Recalls
Other recent issues with DePuy knee systems have led to increased rates of revision surgeries. Revision surgery is done when an artificial knee component or system fails and needs to be replaced. This may occur if the knee system has reached the end of its expected life, with normal wear and tear causing it to break down, but revisions are also needed when knee systems fail prematurely or causes damage or pain.
Several DePuy knee systems have been found in recent years to cause higher numbers of revision rates than are expected. The high revision rates indicate that something is wrong with the system or a component, and can lead to a recall. In 2015 several thousand LCS Complete knee system inserts were recalled because of exceptionally high revision rates in Australia.
In the U.S. in 2017 higher revision rates were being reported for a Sigma implant. Called the Sigma HP PFJ cemented trochlear implant, this component was implicated in the high number of revisions in patients who had received the knee system. The implant had the potential to cause the joint to come out of alignment, to become unstable, or to become dislocated, all issues that can lead to the need for revision surgery. DePuy issued the safety warning, recalled existing parts, and then discontinued the implant.
Many people who have had DePuy components and knee systems used to treat damaged, arthritic knee joints have suffered serious consequences from faults and revision surgeries. It is important to be aware of recalls if you have a DePuy knee but also to speak up if your knee has caused you pain or lack of mobility. Some of the people who have been harmed by this company’s products are filing lawsuits, claiming that DePuy failed to warn them or their surgeons about the risks or the potential flaws in their artificial joints.