The DePuy Knee Replacement system are different medical devices that are used to replace a part or all of the damaged knee joint. These medical devices are used to meet different patient needs such as knee revision surgeries, partial knee replacement surgeries, and total knee replacement surgeries. Depuy’s knee replacement products include Attune, Sigma, LCS Complete, and S-Rom Noiles. 

Knee replacement is designed to help relieve pain from joint trauma or osteoarthritis. This process, which dates back to the 1800s, substitutes a damaged knee joint with an artificial joint or implant. 

Prescription Name and Overview

An estimated number of 700,000 patients undergo knee replacement surgery in the US alone each year. It is estimated that by the year 2030, the number of knee replacement surgeries may reach up to 3.5 million.

Knee replacement surgery is an option for people with severe knee damage. When knee pain medicines, knee injections, and other treatments are no longer helping, a doctor may recommend a knee replacement surgery to relieve constant pain and allow a more mobile and active lifestyle. More than 90% of those who undergo knee replacement experience great relief from knee pain. 

A knee replacement procedure happens when the surgeon removes damaged cartilage, bone or the whole knee joint a of the injured knee joint and replaces them with a man-made surface of metal and plastic. By replacing the knee joint with artificial parts, surgeons hope that the patient would live a more normal life and be able to participate in daily activities that would lead to a better quality of life.

There are two types of knee replacement surgery:

1. Total Knee Replacement (TKR)-both sides of the knee joint are replaced
2. Partial Knee Replacement (PKR)- only a side of the joint is replaced in a smaller operation

DePuy Synthes claim that their knee replacement systems, most especially Attune, has “shown statistically significant improvements in patient recorded outcomes compared to certain leading brands.” They have also stated that “in a clinical study, physical therapists noted that Attune Knee patients had significantly greater range of motion compared to other leading knee replacement, both two and six weeks post-surgery.”

Generic Name and Overview

Knee replacements involve the surgical removal all or a portion of the knee joint that is not working properly and replacing it with an artificial joint. These kinds of surgeries are expensive. However, researchers have discovered that the actual manufacturing of the implant costs only 30% of the final cost, and the marketing and sales costs add 40% to the sales price. 

Companies have started to produce knee replacement implants that are designed to replicate existing implants with good results also. However, these are all still subject to FDA approval.

OTC  Name and Overview

Manufacturer

DePuy Orthopaedics (DePuy Synthes) is the largest medical and pharmaceutical products company in the world. It is the manufacturer of a wide range of  High-Flex knee implants called the DePuy Knee Replacement system. It is a subsidiary of the global health conglomerate Johnson & Johnson. 

According to the official website of DePuy Orthopaedics, they “provide one of the most comprehensive portfolios of orthopaedic solutions in the world with specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery, and sports medicine. Founded in 1895, DePuy Orthopaedics was the first commercial orthopaedics company in the United States.”

Labeled Indications

Knee replacement surgery is recommended when the knee joint is worn or damaged to the extent that mobility is limited and there is constant pain even when at rest. 

The most common condition for knee replacement surgery is osteoarthritis. Other conditions include:

• Rheumatoid arthritis
• Psoriatic arthritis
• Hemophilia
• Gout
• Bone dysplasias
• Avascular necrosis
• Knee injury or trauma
• Pain and loss of cartilage due to knee deformity

Active Ingredients

Knee Replacements don’t have any active ingredients since they are made of metal alloys, ceramic material, or strong plastic parts. 

What Is It Used For?

One of the first joints that gets overused through time is the knee. Along with other factors that are prevailing in our lives today such as obesity and inflammatory diseases, knee replacement surgeries has been a growing demand in the US. 

 DePuy Knee Replacement manufactures a system of devices that offer total knee replacement in three compartments: the medial compartment (inner knee), the lateral compartment (outer knee) and the patellofemoral compartment (front of the knee) where the whole joint is removed from the top of the tibia to the bottom of the femur. 

How Does it Work?

DePuy knee replacement products work to replace knee joints that have been “worn out” by age or damaged by other factors such as sicknesses and diseases, obesity, trauma, deformities, and other conditions. 

The knee joint is where the femur or thighbone, tibia or shinbone, and fibula meet. The kneecap or patella moves up and down against the femur and is located in front of the knee. The knee joint is connected by ligaments, cartilage, and muscles that help form the joint hinge and allows flexibility. During a knee replacement surgery, only the femur, tibia and patella are affected. 

The three parts of a knee implant include:

• Femoral component- This metal component is attached to the end of the femur and has a groove that lets the patellar component to smoothly move up and down as the knee moves.
• Tibial component- This two-piece metal and plastic component is flat and is attached to the tibia. The metal part is placed on top of the shinbone and has a stem that is inserted into the shinbone for support and stability. The plastic part works as a buffer between the metal tibial component and the metal femoral component.
• Patellar component- This plastic component is shaped to match the dome-shape of the kneecap or patella. The alignment of the patellar component to the femur is crucial for the femoral component to properly function and is held in place by the quadriceps tendon and patellar tendon.

Usually, these three components are cemented in place, but some doctors allow the bone to grow into the implant by using a cementless technique. This increases stability but may only be used on young and healthy patients who have a strong bone structure around the knee.  

All knee replacement procedures consist of a component that attaches to the thigh bone, another that attaches to the shin bone, and one that attaches to one of the two lower leg bones. 

What are the Approved Uses?

Total knee replacement is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. 

The DePuy Knee Replacement products are approved for:

• Attune- this line of knee systems bears the company’s latest and most advanced complete artificial joints and knee revision system. The Attune line of knee systems are made of metal and plastic parts. Its design promises to provide mobility, stability, and faster healing. DePuy Attune Knee System is intended for cemented use as a total knee replacement system. Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.
• Sigma- this line of complete knee artificial joints and knee revision system was developed from the earlier product, PFC Total Knee System. In order to give surgeons some choices for unique patient needs, they have offered knee replacements that have fixed bearings and mobile bearings. This line also offers a partial knee system for patients who do not need to change the complete knee joint. 
• LCS Complete- the original line of this knee system uses an artificial kneecap in lieu of a rotating platform or bearing.  Recently, a new version of the RCS Complete released one with a rotational bearing. This line was designed for patients who suffer from arthritis and includes components made of both metal and plastic.
• S-Rom Noiles- this complete knee system can be used in total and revision surgeries. It has a hinge and rotation design that is designed for patients with instability in tissues or with damage in the surrounding bone. 

Production Anecdotes / History

In 1985, a travelling pharmaceuticals salesman named Revra DePuy founded the DePuy Manufacturing in Warsaw, Indiana. He started by producing a fiber splint to replace the wooden barrel staves that were used for setting broken bones. 

In 1998, Johnson & Johnson acquired Depuy and has been operating under Johnson & Johnson Medical organization. It operates in United Kingdom, Germany, France, Japan, and Australia. 

Today, DePuy has more than 200 orthopedic products. It is a leading designer, manufacturer, and distributor of orthopedic products and devices. Separated by five divisions, (DePuy Orthopaedics, DePuy Acromed, DePuy ACE, DePuy CMW, and DePuy International), it agreed to merge with Synthes in 2011, and became the world’s largest corporation. 

Precautions

Some risks of complications include:

• Infection in the wound or the new prosthesis
• Blood clots
• Poor wound healing
• Bone fracture during surgery
• Bleeding
• Heart attack, stroke, or lung complications

Other common complications are:

• Swelling and stiffness
• Pain and soreness
• Nerve and tissue damage
• Blood clots
• Joint infection- this is considered rare and happens in less than 2% of the patients but is considered one of the most serious complications
• Loosening of the implant- may be caused by defective product or poor positioning during surgery. This is a primary cause for revision surgery
• Metallosis- this is a rare but possible complication of knee replacement surgery. Also called metal poisoning.

Long-Term Use Considerations

A knee replacement surgery has risks for complications. These considerations include:

• Deep joint infections
• Fracture of the bones where the joint is attached
• A loosening of the artificial joint
• A decreased range of motion in the operated knee joint
• Shifting in the joint
• Dislocation of the knee replacement
• Metallosis or metal poisoning 
• Sinking of the joint into the soft bone tissue of the leg
• Bleeding under the skin
• Blood clots in the deep veins or Deep Vein Thrombosis (DVT)
• Pulmonary Embolism
• Nerve and artery damage
• Allergic reactions to the metal components in the implant
• Implant failure

Drug Interactions

Drug interactions happen when a substance that you are taking changes or disrupts a drug or a medical implant and its intended function. Interactions may be harmful to you, increase your risk for serious side effects, or inhibit a drug from functioning properly. Always consult a doctor if you are going to start a medication with a new drug. 

Can Interact with the Following

Following a knee surgery, there are medications given to provide after-care and minimize pain, nausea, prevent blood from clotting inside the veins, and reduce the risk of infections. Always ask your doctor if you are taking other medications other than the ones that are prescribed for you after your surgery.

Can’t Interact with the Following

Some medications that may be given may have interactions with other drugs. It is important that you ask your doctor if the vitamins, over the counter medicines, herbal supplements, or other medications you are taking may interact with your knee replacement after-care medications.

Long-Term Side Effects

As with other surgeries, a knee replacement surgery carry some side effects. Some side effects come from the body’s reaction to the implant, some from the body’s reaction to the operation, and some from the device’s reaction inside the body. 

Some of these are:

• Complications from the Anaesthesia- when a person has another serious health problem, such as lung or heart disease, complications from anaesthesia may arise.
• Bleeding- sometimes, after surgery, pooling of blood can occur under the skin and cause swelling. 
• Blood clots- one of the long-term risk of knee replacement surgery is when blood clots form in the deep veins of the legs. This is called Deep Vein Thrombosis or DVT. Further problems arise when this clot breaks free and travels to the lungs or brain and blocks the flow of blood there. 
• Nerve and Artery Damage- there are some rare cases when a surgeon may accidentally cut a nerve or blood vessel in the site of the surgery. Another procedure is necessary to repair this damage. However, there may be a permanent loss of feeling or movement in the area if the nerve does not heal properly. 
• Metallosis- this happens when metal pieces rub against each other and break off tiny metal pieces into the knee joint and bloodstream. This causes the femoral and tibial pieces to wear down from high usage and causes metal poisoning.
• Allergic Reactions- in some people, implants can trigger an allergic reaction to metal. This produces symptoms like swelling of the area where the implant was placed, rashes, blisters, weakness, headaches, loss of function in the implant area and headaches. 
• Implant Failure or Loosening of the implant- may be caused by defective product or poor positioning during surgery. This is a primary cause for revision surgery

FDA Warnings (History Of)

DePuy Orthopaedics, the largest medical and pharmaceutical products company in the world has issued a recall of some of their implant components since 2008. In 2010, the FDA warned DePuy about reports that they have marketed their items without approval, though one of these items was later on approved and some were taken out of the market. 

In 2011, DePuy voluntarily recalled some of their products when the FDA sent them a warning letter stating that the marketing and selling of these products were not approved by the FDA. There were also findings that DePuy altered several devices and were currently marketed as safe and effective. 

DePuy Synthes claim that their products are longer lasting alternatives to other knee replacement components. However, reports of failures and adverse reactions have piled up in recent years, reaching to up to 1,500 reports on the Attune Knee Replacement product only. Other DePuy products have also faced complaints and lawsuits so that in 2014, FDA started to issue a recall on the S-ROM Noiles hinge system. 

Products that have been recalled, penalized and have received multiple lawsuit include:

• TruMatch Personalized Solutions
• PFC Sigma Knee System with titanium components
• PFC Sigma Knee System components, sizes 2.5, 7, and 8
• PFC Sigma Knee System 30mm-40mm thick inserts
• Femoral heads that include a 14/16 taper
• Femoral heads with offsets greater than +12
• LPS Diaphyseal Sleeve
• LCS Duofix Femoral Component

Other Common Side Effects

• Loosening or instability of implant
• Device components’ shifting of position
• Tibial subsidence (an implant sinks into the tibia)
• Bending, breaking, and other implant deformities
• Infection of the wound
• Stiffness of the knee
• Deep infection of the joint replacement, needing additional repair surgery
• Bleeding in the knee joint
• Ligament, artery or nerve damage
• Blood clots or Deep Vein Thrombosis
• Pain
• Bone breakage on the bone involving the operation

Lawsuits

There have been serious complications after a DePuy knee replacement surgery. While the DePuy Knee Replacement devices were marketed to give people with severe knee pain and knee damage a chance to live normal lives, complaints have piled up from patients who have been suffering from device malfunctions. 

Johnson & Johnson marketing executives claim that their DePuy Attune knee replacement device can last more than 15 years of use. Sadly, the devices have been failing within 6 months of use. 

These instances have led to serious patient injuries, product recalls and lawsuits. Researches have indicated a need for caution in using DePuy High-flex Knee replacement devices for the side effects from using these devices could lead to a more serious health problem. 

In September 2017, a lawsuit was filed in the Circuit Court of Tuscaloosa County by Cunningham Bonds LLC against Johnson & Johnson and its subsidiary, DePuy Synthes on the allegation that they created a defective device. 

The firm states a statement that “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 revision surgeries are often more painful and invasive than the initial replacement surgery.”

More lawsuits are expected to be filed as the devices have been implanted to thousands of patients already. Many of those implanted had to go through complicated revision surgeries to correct the device failure. 

https://www.drugwatch.com/knee-replacement/depuy-attune/

https://www.drugdangers.com/manufacturers/depuy-orthopaedics/

https://medlineplus.gov/kneereplacement.html

https://www.depuysynthes.com/patients/knee/pre-total-knee-replacement-surgery?utm_source=DShome&utm_medium=Banner

https://www.recallreport.org/recalls-and-alerts/depuy-knee-replacement/

https://www.drugdangers.com/knee-replacement/

https://www.medicalnewstoday.com/articles/310636.php