Smith & Nephew Hip Replacement

Smith & Nephew is a UK-based medical device company that manufactures a number of hip replacement products. Some Smith & Nephew hip replacement devices, like the R3 Acetabular System and metal liner, have caused the need for a high number of required revision surgeries. Issues associated with these products have been the bases for lawsuits against the company. Several of Smith & Nephew’s hip replacement devices have been recalled due to this higher failure rate.

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Who Is Smith & Nephew?

Smith & Nephew is a company that manufactures medical devices in three main categories: advanced wound management, orthopedics and trauma, and sports medicine. The company started out as a pharmacy in 1856. Over the years, the company grew to have large-scale operations across the globe, designing and manufacturing medical devices. Today, Smith & Nephew is in over 100 countries and has over 15,000 employees. In 2021, the company boasted an operating profit of $593 million.

What Products Does Smith & Nephew Make?

Smith & Nephew’s product catalog contains more than 50,000 products. These products range from wound care products to orthopedic and sports medicine products. Among the Smith & Nephew products are knee and hip replacement devices. 

What Are Smith & Nephew Hip Replacement Devices?

Smith & Nephew manufactures thirty-six devices that are used for various orthopedic reconstructions. Approximately one-third of those devices are used for hip replacements.

Those devices are: 

  • ANTHOLOGYS Hip System
  • BHRS Birmingham Hip Resurfacing
  • R3 Acetabular System
  • REDAPT Revision Femoral System
  • SMFS Short Modular Femoral Hip
  • VERILASTS Technology
  • EMPERION Modular Hip System
  • SPECTRON Hip System
  • ECHELON Hip System
  • CONQUEST FX Femoral Hip Implant
  • TANDEM Hip System
  • REFLECTION Acetabular Cup System

What Is a Hip Replacement?

Hip replacement is a surgical procedure, also referred to as hip arthroplasty. An orthopedic surgeon will remove portions of the hip joint and replace them with artificial parts to perform the surgery. Manufactured products may replace a portion of the joint or the entire joint in the case of a total hip replacement. The synthetic replacement parts mimic natural hip joint function. Hip replacement is performed to relieve pain due to a diseased or damaged joint, improve the function of the joint, and increase mobility.

What Is the History of Hip Replacement Surgery?

Degenerative hip disease has been a condition humans have suffered from since our earliest history. However, before the ability to provide surgical repair in the modern era, hip replacement was typically treated through assistive devices such as crutches, ultimately leading to immobility for the patient. 

Hip surgery began in the early 1700s, with surgeons removing portions of the diseased hip, hoping bone growth would replace the diseased parts. Removing diseased portions of the hip continued into the mid-20th century. 

However, by 1840, doctors were looking for replacement materials that could be placed between joint surfaces, beginning with wood and fat tissue. This eventually led to the creation of the first replacement joint made of ivory and attached with metal screws. By the early 1900s, doctors were researching and using other materials and using them to cover the joint, trying to find the best solution for pain reduction and increased mobility. At this time, it was discovered that replacement, not just covering, portions of the bone would provide better results. By 1950, research combined to allow for the replacement of the joint with materials that provided for successful treatment, leading to the development of modern hip replacement. 

In the following decades, research and technological advances have led to surgical hip repair using less invasive treatments and better biologically compatible materials that resist wearing down. As a result, hip replacement surgery is one of the most commonly performed orthopedic surgeries in the modern era.

What Are Common Products for Hip Replacement?

Manufactured products that will fit the remaining bone structure are typically made from metal.

The most used metals are:

  • titanium alloys
  • stainless steel
  • high-strength alloys
  • alumina
  • zirconia
  • zirconia toughened alumina

In addition to metals, the joint itself may be made of ceramic, plastic, or a combination of these three components. Generally, surgeons will avoid using metal on metal surfaces due to complications that may arise. In 2016 the FDA passed a ruling that all metal-on-metal hip replacement devices must have FDA approval before going to market. No metal-on-metal devices have received approval for use since this ruling.

Different methods are utilized for bonding the replacement pieces to the existing bone. Cemented replacements use specialized glue or cement to attach parts, while uncemented attachments use a porous surface to allow the natural bone to grow and connect to the replacement product. The use of uncemented replacements requires time to allow for bone growth which requires limitations on patient activity during the recovery process. Doctors may choose either system or a system that combines the two attachment processes.

Commonly used hip replacement product manufacturers include:

  • Smith & Nephew, Inc.
  • DePuy Synthes, a division of Johnson & Johnson
  • Zimmer Biomet
  • Stryker Orthopaedics
  • Wright Medical Group

When Would Someone Need a Hip Replacement?

Initially, treatment for degenerative joint diseases deals with the pain and other symptoms common for these types of joint problems. The initial treatment for pain management consists of steroids, anti-inflammatory drugs, painkillers, and local injections.

Your doctor may recommend hip replacement surgery if pain, mobility, and joint function significantly impact your health and lifestyle.

Before recommending surgery, doctors may have patients use other treatment options, such as:

  • pain medications,
  • physical therapy and exercise,
  • activity changes that will limit strain on the hip joint,
  • use of assistive devices like a cane, crutch, or walker.

If non-surgical therapies do not provide the needed return of function and pain reduction, and additional health conditions do not increase the surgical risk, your doctor may recommend surgery. You and your doctor will determine the best treatment approach for your situation.

What Diseases Could Damage the Hip Joints?

If all of these treatments fail, total hip replacement is the last resort to rehabilitate patients suffering from certain degenerative joint diseases.

These diseases may include:

  • Osteoarthritis as a result of antigen-antibody reaction
  • Traumatic arthritis as a result of inflammation after trauma
  • Avascular necrosis due to compromise in blood supply
  • Fused hip joint due to inflammatory scarring or any other cause
  • Slipped capital epiphysis due to shear stress
  • Fracture of the pelvis and diastrophic dysplasia.
  • A cancerous tumor(s) in the hip joint

What Do Hip Replacement Devices Treat?

The diverse varieties of hip components are also used for the treatment of other diseases, injuries, or other issues which may include:

  • Rheumatoid arthritis (an autoimmune attack)
  • Arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia;
  • Treatments of non-union
  • Femoral neck fracture (trauma)
  • Fractures of the trochanter of the femur along with head involvement
  • Fracture-dislocation of the hip
  • Correction of deformity

What Is Arthritis?

Arthritis is a condition in which the joints swell and are tender. There are a variety of different types of arthritis named based on what causes the joints to swell. Arthritis is usually characterized by pain in the joints as well as stiffness, both of which can worsen with age.

What Is Osteoarthritis?

Osteoarthritis is a type of arthritis that occurs when the cartilage, which is supposed to protect the ends of the bones and prevent them from rubbing against one another, wears down over time. This is the most common type of arthritis and it affects millions of people across the world. 

Which Joints Are Most Commonly Affected by Osteoarthritis?

Osteoarthritis typically occurs in the:

  • Hips
  • Knees
  • Spine
  • Hands

However, it can impact any joint in the body.

What Are the Symptoms of Osteoarthritis?

The most common symptoms of osteoarthritis include:

  • Bone spurs
  • A grating sensation
  • Swelling
  • Tenderness
  • Pain
  • Stiffness
  • Reduced flexibility

What Are the Risks of Hip Replacement?

All surgical procedures include some element of risk.

Hip replacement comprises some of the following risks before and after surgery:

  • bleeding
  • infection
  • blood clots
  • change in leg length
  • nerve damage
  • bone fracture
  • pain or stiffness
  • dislocation of the joint
  • loosening or wear of the artificial joint
  • unrelieved joint pain
  • embolism
  • second replacement surgery due to complications, malfunction, or wearing down of replacement pieces

What Are the Signs of a Failing Hip Replacement?

Although hip replacement surgery has become increasingly popular and successful, failure of the surgery does occur.

These failures can be caused by many factors, including:

  • injury
  • damage or wearing down of the manufactured products
  • loosening of the implant from the bone
  • bone loss
  • infection
  • malfunctioning product
  • surgical error

Indications that your hip replacement is failing may include the following:

  • damaged bone tissue
  • unrelieved joint pain
  • lack of flexibility and movement
  • difficulty walking
  • instability in the joint
  • hip dislocation

What Is the Smith & Nephew R3 Acetabular System?

The R3 acetabular system was introduced by Smith & Nephew in 2007. Smith & Nephew’s R3 acetabular system, combined with the company’s various hip stems, was designed to provide greater stability, a wider range of movement, and longevity.

A complete hip replacement system is comprised of:

  • Hip stem
  • Femoral head
  • Liner
  • Acetabular cup

The R3 acetabular system is an acetabular cup with a liner.

What Is an Acetabular Cup?

The R3 acetabular cup component consists of an enhanced porous ingrowth surface to satisfy the needs of both primary and revision hip surgery. It has an optimized locking mechanism and the ability to accommodate polyethylene, metal, or ceramic liners. A study on the safety and efficacy of the new StikTite porous ingrowth surface claims to provide a superior “scratch-fit” due to its greater coefficient of friction and less micromotion. The high porosity StikTite and lower porosity Roughcoat surfaces provide excellent “biologic fixation.” The StikTite coating is designed to provide proper fixation and enhance stability. This not only helps hold the weakened bone but also allows the normal growth of the bone. The R3 Acetabular Cup is designed for multiple weight bearing. The multi-bearing cup is engineered in a way to reduce wear and increases the life of the apparatus. The cup can support CoCr, OXINIUM, and Biolex femoral heads and can hold larger cups for a greater range of movements. The internal surface is lined by Cross-linked polyethylene (XLPE) to reduce friction and enhance stability and resilience. The R3 acetabular system allows the surgeon to select the material according to the need of patients.

What Are the Important Features of an Acetabular Cup?

Important features of an acetabular cup include:

  • Accommodation of Larger femoral heads for a greater range of movements.
  • Complementation between neck geometry and liner allows maximum head/shell ratios for optimal functioning.
  • The liner equally surrounds the head from all sides, thus enabling the enhanced range of motions which ultimately reduces the risk of joint subluxation, nerve impingement, and prosthetic loosening—all contributors to revision surgery.

Recent modifications to the R3 acetabular system include multi-hole shells with Constrained Liners and Big Femoral Heads.

What Is a Liner?

The Liner is an articular surface between the head of the femur and the acetabular cup. A good liner should be resilient, tough, erosion-free, and provide enough room for the femoral head. Smith & Nephew recommends the liner be made of Polyethylene (XLPE or PEX) which is thicker at the apex and load-bearing areas. According to a 5 year study, the head penetration of a second-generation XLPE liner remained low at 5 years, and the wear rate calculated after the first year was “low in all directions”. The liner is also engineered in a way to allow repositioning during the surgery.

Did the Smith & Nephew R3 Acetabular System Cause Side Effects?

Because of the metallic liner in the R3 acetabular system, many patients did experience negative side effects such as pain, metallosis, and the need for revision surgery due to device failure. 

Did the Smith & Nephew R3 Acetabular System Cause Pain in Patients?

Pain is a very common complication of hip replacement using the R3 acetabular system, especially in younger patients. Almost 20% of patients complain of post-operative pain at the site of implantation. The pain is usually associated with signs of inflammation i.e. redness, tenderness, swelling, warmth, etc.

What Is Metallosis?

Metallosis is the deposition of metal debris resulting in increased plasma concentration of metals. Metallosis is caused by shaving off metals by friction. In a recent study, it was demonstrated that almost all patients suffer from severe metallosis after 10 years of having a metal-on-metal implant. The larger cup size increases the likelihood of developing severe metallosis.

When Is Revision Surgery Due to Device Failure Needed?

There are a variety of problems that can lead to revision surgery. Mechanical failure, infection, and recurrent hip dislocation can all prompt a doctor to consider revision surgery. The revision surgery is often more dangerous than the initial surgery and can further damage the area of the implant.

Which Smith & Nephew Hip Implants Have Been Recalled?

Several Smith & Nephew hip implant devices have been subject to FDA recall including the R3 Acetabular system in 2012, Birmingham Hip Resurfacing (BHR) system in 2015, and the Modular SMF and Redapt Revision Hip systems in 2016.

The recalls were voluntarily issued after a large number of injury reports identified device loosening, dislocations, metallosis, and early failure rates that were two or more times greater than expected.

Were Metal Components Responsible for Failures?

Problems with the Smith & Nephew R3 and BHR devices have occurred mainly due to the metal-on-metal (MoM) construction. Though MoM design is intended to be a more durable option, severe problems have resulted from the possible grating of metal surfaces against one another. Grating of the metal surfaces has allowed for local tissue destruction and systemic metal poisoning in some Smith & Nephew hip implant recipients.

The MoM construction likely played a large role in the need for recall of the R3 Acetabular and metal liner and the Birmingham Hip Resurfacing devices.

Why Were Smith & Nephew Hip Replacements Recalled?

Hip replacement injuries and faulty replacement devices are one of the most common issues in the medical community. As much promise as hip replacement surgery offers some people, it causes others a great deal of pain and suffering. Many manufacturers of hip replacement devices have experienced problems, and Smith & Nephew is no exception.

Smith & Nephew is based in London and manufactures replacement systems for shoulders, knees, and hips. They are the fourth largest manufacturer in the United States, despite having a number of issues with their various replacement devices. Recalls on their devices have been initiated voluntarily by Smith & Nephew, as well as by the FDA.

Two of the most recent recalls involved the Smith & Nephew R3 Acetabular system in 2012 and the Birmingham Hip Resurfacing (BHR) system in 2015.  Both recalls were voluntary but may have resulted in thousands of hip implant failure cases.

The recalls were issued in response to problems with the device loosening, causing infection, dislocating, trigging metallosis, and failing completely. The average rate of early failure of hip replacement devices is just under 3%, but the R3 Acetabular has a more than 6% failure rate and the BHR rates may be higher.

How Do Metal Components Destroy Surrounding Tissue?

Smith & Nephew’s hip implant devices include a cup made from plastic, ceramic, or metal, a femoral head made from the company’s proprietary metal blend or ceramic, and a liner made from the proprietary metal or plastic. The problems occur mainly with the metal-on-metal (MoM) device models. Though MoM construction is intended to be a more durable option, many have experienced issues due to the possible grating of metal surfaces against one another.

Hip implant devices with metal liners made by Smith & Nephew are constructed of a cobalt-chromium blend. This blend has also been used in other replacement devices and is known to release metal chromium and cobalt ions into the body which may be absorbed into the bloodstream.

The ions from these metals are considered carcinogenic and have been linked to DNA damage and blood poisoning. Cobalt is also known to cause heart muscle disease. Research has shown the device itself does not cause metal toxicity in the body, but other complications can eventually lead to toxicity or metallosis. Even patients who initially respond well to the system could eventually have problems and require revision surgery.

When localized damage occurs in the tissue near the device, it leads to the destruction of muscle and bone of the joint. As the bone and muscle are destroyed, the device loosens and may fail. This can also cause a great deal of discomfort and a lack of mobility in users and may ultimately require revision surgery.

As a reason for voluntary recalls issued for the R3 Acetabular system, the Birmingham Hip Resurfacing system, and the Modular SMF and Redapt systems, Smith & Nephew cited higher-than-expected adverse event or failure rates.

What Smith & Nephew Hip Implant Lawsuits Are There?

Smith & Nephew has faced thousands of lawsuits regarding the R3 Acetabular device, starting in 2013, most of which were quietly settled before 2015.  The company has also faced hundreds more lawsuits for the Modular SMF, Redapt, and Birmingham or BHR devices and still more may be expected. Patients with Smith & Nephew hip implant devices are encouraged to notify their doctors if they experience any issues with pain, discomfort, lack of mobility and range of motion, flu-like symptoms, or other complication. 

What Smith & Nephew Hip Replacement Lawsuit Settlements Were There?

While the exact settlement amounts of the earlier lawsuits against Smith & Nephew aren’t known, in 2015, the company had set aside as much as $203 million dedicated to covering the costs of further lawsuits.

What Smith & Nephew Hip Replacement Class Action Lawsuits Are There?

There aren’t any current class action lawsuits against Smith & Nephew regarding their hip replacement devices, but there is multi-district litigation (MDL), which is lawsuits from different locations consolidated and then transferred so that one judge can hear all of the cases at once. This is typically done to speed up the litigation process when cases are more complex. In the Smith & Nephew MDL, the individual lawsuits were filed in 2017 and were consolidated into an MDL in 2019 and are still ongoing. As of April 2019, there were 609 cases in the MDL.

Should I Consider a Smith & Nephew Hip Replacement Lawsuit?

If you underwent a hip replacement surgery and received one of the recalled Smith & Nephew hip replacement devices and were harmed by it or had to undergo revision surgery early as a result, you may have a case. You should talk to your doctor to be certain that your hip replacement is one of the recalled models by Smith & Nephew and that your pain and revision were caused by the hip replacement device’s premature failure or defect.

How Do I Find a Smith & Nephew Hip Replacement Attorney?

Seeger Weiss’ lawyers are experienced in representing plaintiffs in lawsuits against medical device corporations. Contact Seeger Weiss to schedule a free consultation to determine the strength of your case against Smith & Nephew. You won’t have to pay anything unless your case is successful.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.


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