Who Is Stryker?
Founded in 1941, Stryker is a long-standing company providing products and services to the medical community. Today, Stryker is a Fortune 500 company and one of the world’s leading medical technology producers. Stryker has locations in over 75 countries across the globe and 46,000 employees. Their annual sales were estimated at $17 billion in 2021.
What Products Does Stryker Make?
Stryker’s product catalog contains more than 57,000 products. Their products span many categories, including orthopedics, medical and surgical, neurotechnology, and spine. Among the Stryker products are hip replacement devices.
What Are Stryker Hip Replacement Devices?
Stryker manufactures multiple devices for partial and total hip replacement.
Those devices are:
- ABG II Modular Neck Stem
- Accolade II
- LFIT V40 Femoral Head
- Modular Dual Mobility
- Rejuvenate Modular Neck System
- Restoration Modular
- Secur-Fit Advanced
- Trident II
- Tritanium Acetabular Shell
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 the natural hip joint. 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
- 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:
- Stryker Orthopaedics
- DePuy Synthes, a division of Johnson & Johnson
- Zimmer Biomet
- Smith & Nephew
- Wright Medical Group
When Would Someone Need a Hip Replacement?
Initially, treatment for degenerative joint diseases deals with the pain and other symptoms common to these 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 joint pain and 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 worldwide.
Which Joints Are Most Commonly Affected by Osteoarthritis?
Osteoarthritis typically occurs in the:
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
- 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:
- 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
- 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:
- damage or wearing down of the manufactured products
- loosening of the implant from the bone
- bone loss
- 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 Stryker ABG II Modular Neck Stem?
The ABG II Modular Neck Stem was introduced by Stryker in 2009. Stryker’s ABG II Modular Neck Stem was a system offering choices of 8 left hip stems, 8 right hip stems, and 10 modular neck pieces. The differing products enabled physicians to identify the best combination of parts to be used to mimic an individual patient’s personal anatomy. The design was intended to provide better stability and be easier for surgeons to implant. Originally, the product was marketed toward younger patients with the belief that the product would last longer, resisting metal corrosion and typical wear and tear.
The neck pieces of the system were made with chromium and cobalt, while the stems were coated with titanium. The ABG II Modular Neck Stem was designed to be a cementless implant product and used along with one of the femur head products also provided by Stryker.
Did the Stryker ABG II Modular Neck Stem Cause Side Effects?
Because of the metallic surfaces of the neck and stem of the ABG II Modular Neck Stem, many patients did experience adverse side effects such as:
- tissue damage
The complications from the use of the ABG II Modular Neck Stem implants required a significantly higher than the typical need for revision surgery due to device failure.
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. A recent study demonstrated almost all patients suffer from severe metallosis after 10 years of having a metal-on-metal implant.
What Are Pseudotumors?
Pseudotumors are tumor-like growths that occur in the tissue surrounding a prosthetic implant. They can be solid or partially liquid masses and can mimic the effects of an infection in the tissue. If pseudotumors develop in the tissue they destroy the tissue in the area and require revision surgery to repair the damage. Pseudotumors are reported to occur in up to 3% of typical hip replacement surgeries.
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. Unfortunately, revision surgery is often more dangerous than the initial surgery and can further damage the implant area.
Which Stryker Hip Implants Have Been Recalled?
Several Stryker hip implant devices have been subject to FDA recall, including the ABG II Modular Neck Stem and Rejuvenate hip implants in 2012. At the time of the recall, all manufacturing and sales of these products were discontinued.
In addition to these recalls, the Accolade TMZF hip stem faced repeated recall events between 2009 and 2013 due to packaging and manufacturing errors.
In 2008 the FDA sent a warning letter to Stryker for additional hip implant products, the Trident PSL and Hemispherical Acetabular Cups. While Stryker maintain the products were safe, a recall was issued after failing additional quality testing completed by Stryker.
Below is a list of hip replacement systems recalled by Stryker:
- ABG II
- Meridian TMZF Stem
- Citation TMZF Stem
- Accolade TMZF
- LFIT V40 Femoral Head
- Tritanium Acetabular Shell
Were Metal Components Responsible for Failures?
Problems with the Stryker ABG II Modular Neck Stem 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. Grinding of the metal surfaces has allowed for local tissue destruction and systemic metal poisoning in some Stryker hip implant recipients.
The MoM construction likely played a significant role in the need for the recall of the Stryker hip implant products.
Why Were Stryker Hip Replacements Recalled?
Hip replacement injuries and faulty replacement devices are one of the most common issues in the medical community. Unfortunately, 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 Stryker is no exception.
Stryker is based in the United States and manufactures replacement systems for knees, and hips. They are the largest manufacturer in the United States, despite having several issues with their various replacement devices. Recalls on their devices have been initiated voluntarily by Stryker.
Two of the largest recalls involved the Stryker ABG II Modular Neck Stem and the Rejuvenate hip implants in 2012. Both recalls were voluntary but may have resulted in thousands of hip implant failure cases. The recalls were issued in response to problems mostly caused by complications caused by metal-on-metal components.
How Do Metal Components Destroy Surrounding Tissue?
Stryker’s hip implant devices include femoral stems, acetabular cups, and neck stems that are either made from metal or coated on a metal surface. Research has shown that metal-on-metal (MoM0 junctions for joint replacement products can cause a significantly increased risk of device failure. 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 manufactured by Stryker are typically constructed of cobalt, chromium, or titanium. This combination of metals has also been used in other replacement devices and is known to release metal 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 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 destroys the joint’s muscle and bone. The device loosens and may fail as the bone and muscle are destroyed. 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 Stryker hip implant devices, Stryker cited higher-than-expected adverse events or failure rates.
What Stryker Hip Implant Lawsuits Are There?
Stryker has faced thousands of lawsuits regarding their hip replacement products, particularly in regards to the ABG II and Rejuvenate implants. Hundreds of additional lawsuits have been filed for the LFIT V40 Femoral Head.
Currently, complications from the Tritanium Acetabular Shells are being investigated for litigation. Therefore, patients with Stryker 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 Stryker Hip Replacement Lawsuit Settlements Were There?
In 2014 Stryker paid over $2 billion in settlements for the ABG II and Rejuvenate system lawsuits. However, as of October 2022, there are still 81 lawsuits pending in Minnesota Federal Court as multidistrict litigation for these systems.
The LFIT V40 Femoral Head lawsuits were filed in Minnesota and New Jersey. The New Jersey suits were formed into multicounty litigation. Although a confidential settlement was reached regarding the lawsuits for the LFIT V40 Femoral Head in 2018 there are still 581 lawsuits pending mass litigation in Minnesota.
What Stryker Hip Replacement Class Action Lawsuits Are There?
There are no current class action lawsuits against Stryker regarding their hip replacement devices. However, multi-district litigation (MDL) and multi-county litigation (MCL) suits have been created. This type of litigation occurs when lawsuits from different locations are consolidated and then transferred so that one judge can hear all of the cases at once. This is typically done to speed up litigation when cases are more complex. The MDL and MCL lawsuits for the ABG II, Rejuvenate, and LFIT V40 have reached initial settlements. However, all still have cases pending.
Should I Consider a Stryker Hip Replacement Lawsuit?
If you underwent hip replacement surgery and received one of the recalled Stryker hip replacement devices and were harmed by it, or had to undergo an early revision surgery 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 Stryker and that your pain and revision were caused by the hip replacement device’s premature failure or defect.
How Do I Find a Stryker 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 Stryker. 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.