Products Liability
This page is about the recalled Stryker hip implant lawsuits. This page was updated in 2024, but some of the original content remains outdated.
Settlements in the Stryker lawsuits that have been filed around the country are most long done for ASR cases, and the Stryker Rejuvenate hip stem and ABG II modular hip stems as well.
- Exactech hip replacement lawsuits are the big hip replacement claims in 2024
Styker Hip Lawsuit Updates
April 2024 Update: In the Circuit Court of the Third Judicial Circuit in Madison County, Illinois, a resident of Granite City has filed a lawsuit against Stryker Corporation. The complaint alleges that a hip replacement device manufactured by Stryker and implanted in 2008 was defective and unreasonably dangerous, leading to severe pain and necessitating its removal in December 2022.
It is one of the most barebones complaints we have ever seen in a product liability claim. This case was filed in January and then refiled now.
March 2022 Update: There have been many Stryker hip settlements. But there are still 105 Stryker Rejuvenate and ABG II hip implant lawsuits in the MDL class action. The latest big hip replacement lawsuit are Exactech lawsuits.
February 2019 Update: The MDL judge stayed these cases to allow Stryker and the plaintiffs’ lawyers the opportunity to work on a global settlement to these cases.
December 2018 Update: Stryker agreed to an expanded settlement program to compensate patients who underwent revision surgery after the initial settlement cut-off date, covering surgeries performed through December 19, 2016.
Overview of Hip Joint Anatomy
The hip joint, a crucial structure in the human body, connects the thigh (femur) bone to the pelvis and functions as a ball-and-socket joint. This allows for a wide range of motion, essential for activities like walking, running, and sitting. The acetabulum is the cup-shaped socket part of the joint, while the femoral head, a ball-like structure at the top of the femur, rotates within the acetabulum. This design provides both stability and flexibility to the hip joint.
Stryker’s Hip Replacement Systems
Stryker Corporation has developed various hip replacement systems, including the Rejuvenate and ABG II Modular Femoral Hip Stems, which have been identified as defective. These devices are part of a total hip replacement procedure that involves replacing the body’s natural hip joint with an artificial one typically made from metal, plastic, or ceramic.
A standard total hip replacement consists of four primary components: a femoral stem, a femoral head, an acetabular liner, and an acetabular shell. The femoral stem is implanted into the hollowed-out femur bone, the femoral head (either metal or ceramic) is attached to the top of the stem, and this assembly forms the hip joint that rotates within a plastic or ceramic acetabular liner fixed inside the metal acetabular shell.
Hip replacement surgery is typically recommended for patients who suffer from arthritis or extensive fractures. The following are indications for surgery:
- Osteoarthritis: this typically occurs around age 50 when the articular cartilage that layers the hip bones wears away, causing bone-on-bone movement, pain, and stiffness.
- Rheumatoid arthritis: this is a disease that is often hereditary and causes inflammation of the synovial membrane and damage to the articular cartilage.
- Traumatic arthritis: this can result from serious fractures or hip injuries, which may cause osteonecrosis and damage to the articular cartilage.
Implants typically follow the same “ball and socket” model: a socket (half-spherical cup) is implanted into the pelvis, which fits snugly next to a head (the ball). That head attaches to a spike that is cemented or drilled into the to the thigh bone (the femur). Traditionally, these implants have been manufactured from metal and/or plastic.
Modular vs. Monolithic Designs
Traditionally, femoral stems were designed as a single piece, or “monolithic.”
However, the Rejuvenate and ABG II systems introduced a modular design, consisting of two separate components: a cobalt-chromium neck piece and a titanium stem. The femoral stem portion, which is implanted into the femur, is made from a proprietary titanium alloy known as TMZF (titanium, molybdenum, zinc, and iron).
This alloy was patented by Stryker and marketed as being stronger and less rigid than other titanium alloys, with claims of resistance to corrosion and fretting.
Complications and Failures
Despite Stryker’s promotional materials asserting the superiority and safety of their TMZF alloy, significant issues with corrosion and fretting have been reported. The modular junction between the neck and stem of these devices has been prone to corrosion, leading to the release of metal ions into surrounding tissues.
This release can cause a range of severe complications, including tissue and bone damage, the formation of pseudotumors, and a condition known as metallosis. Metallosis is characterized by the accumulation of metal debris in the body, leading to inflammation, pain, and further tissue destruction.
Impact on Patients and Recall
The defective design and manufacture of the Rejuvenate and ABG II devices have resulted in numerous adverse events. Patients implanted with these devices often experience severe pain, discomfort, and the need for additional surgeries to remove and replace the faulty implants.
These revision surgeries are typically more invasive and complex than the original hip replacement procedures, involving higher risks and longer recovery times. The presence of metal particles or debris further complicates these surgeries.
Recognizing the significant problems associated with these devices, Stryker issued a recall for the Rejuvenate and ABG II systems in July 2012. This recall was prompted by the high incidence of adverse events reported by patients and physicians, including issues directly related to the modular junction’s fretting and corrosion. The FDA classified this recall as a Class II recall, indicating that the devices posed a risk of temporary or medically reversible adverse health consequences.
Background on These Lawsuits
Stryker has offered a variety of hip implant systems for the global reconstructive market. The ABG Hip System, Partnership Hip System, Secur-Fit Hip System, Omnifit Hip System, Accolade Hip System, and Restoration Hip System are all comprehensive systems of hip implants designed to address various patient needs and surgical requirements.
However, Stryker’s recall specifically relates to the Trident PSL and Hemispherical Acetabular Cups. These products have been found to be defective and frequently produce an audible noise when moving, such as a squeaking or popping sound. This issue can lead to serious complications, including bone fractures, pain, discomfort, potential shattering of the implants, and often necessitates additional replacement surgeries.
The Stryker Hip Implant lawsuits allege product liability, negligence, and failure to warn claims against Stryker Corporation, Stryker Sales Corporation, and Stryker Orthopaedics, the manufacturer. Plaintiffs assert that the company failed to provide adequate warnings about the risks associated with these implants and did not take appropriate measures to ensure their safety. These legal allegations can be summarized as: “We trusted you to take care of us. And you didn’t.”
Which Stryker Hip Implants Are Defective?
Under pressure from the FDA, Stryker has recalled two devices from their Stryker Trident hip implant series—the Trident Acetabular PSL and the Trident Hemispherical Cups. These products are used for the “socket” portion of the hip replacements.
What Is Wrong With The Stryker Hip Implants?
The recalled Stryker Hip Implants, introduced in 2003, are ceramic. Ceramic implants are a departure from other hip implants then on the market. Up until that time, most hip implants were made with metal and plastic. The ceramic parts were initially recalled because of concerns about sterility from Stryker’s Ireland manufacturing facility. To date, no evidence has been uncovered to point to any significant sterility dangers to patients. Stryker also has a New Jersey facility that manufactures these components, and the company has not recalled those products. However, all of these ceramic components are defective for other reasons.
Regardless of the sterility issue, many of these devices are implanted and have manufacturing defects that have or may cause problems and injuries. These devices are extremely prone to producing audible noises with movement—squeaks and popping sounds are common. Whereas noise rarely happens with hip implants generally, Stryker’s products have an estimated 7% chance of causing frequent noise, according to one investigation. This is significantly higher than any other product on the market.
Many doctors are concerned that the squeaking may be a prelude to other problems with the implants—the ceramic material may break into shards, or the implants may wear out or cause pain and discomfort. In many situations, patients may have no choice but to undergo a subsequent hip replacement surgery, which can cost around $45,000, and carries with it a host of dangers, particularly for older patients. In fact, one reason many patients chose Stryker’s products is that they were told the ceramic devices were more durable and would not need to be replaced in the patients’ lifetimes.
Of course, the squeaking itself is oftentimes loud and regular enough to cause serious social problems. Many patients have posted videos on YouTube of the noises their Stryker hips make, reminiscent of an un-oiled “Tin Man.” Take a look at this YouTube video for some idea.
Timeline Of Events And FDA Warnings To Stryker
February 3, 2003: FDA approves Stryker’s Trident hip replacement system.
January 2005 to April 2007: Company receives a large number of complaints from patients about their Trident hip implants, yet takes no significant action.
March 15, 2007: FDA sends a warning letter over defecting practices in its Ireland manufacturing facility. “This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act (21 U.S.C. § 351(h)), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation.”
November 28, 2007: FDA sends a second warning letter to Stryker. “[C]ustomer complaints have been received for squeaking/noisy ceramic on ceramic hip joints.”
January 22, 2008: Under pressure from the FDA, Stryker initiates a voluntary recall. “As a result of the deviation from internal specifications, the Company is initiating a voluntary recall of Trident PSL and Hemispherical Acetabular Cups manufactured in its Cork facility.”
November 25, 2014: Stryker Corporation agreed to a $1.43 billion settlement to resolve thousands of lawsuits involving its Rejuvenate and ABG II hip implants.
What Is The Status Of The Hip Implant Litigation?
Numerous Stryker Hip Implant cases have been filed in New Jersey state courts because Stryker’s manufacturing facility is located there (and, Stryker is based out of Michigan, which is oftentimes a terrible place to file a lawsuit). The Supreme Court of New Jersey ordered on March 31, 2009, that those cases, and any future Stryker Hip Implant cases filed in New Jersey state courts, are to be transferred and centralized to the Superior Court, Law Division, Atlantic County before Judge Carol Higbee. Settlement amounts have been reached in many of these caess.
What is the Settlement Value of the Stryker Cases
The settlement value of the DePuy ASR hip replacement is expected to be in the $200,000 to $600,000 range. Candidly, the early settlements of the Stryker hip cases have not been as much. This is because the Stryker hips are not metal-on-metal and the science on this is now painfully clear to everyone. Accordingly, we are far more optimistic about Rejuvenate cases.
Other Styker Lawsuits
Below are other recent lawsuits agains Stryker in recent years:
Tritanium Acetabular Shell Lawsuits
Stryker faces ongoing litigation involving the Tritanium Acetabular Shell, which has been reported to loosen after implantation. This loosening can cause significant hip and groin pain, often requiring patients to undergo revision surgeries. These lawsuits stem from patients experiencing instability and severe discomfort due to the device’s premature failure.
ShapeMatch Cutting Guide Lawsuits
Another set of lawsuits involves Stryker’s ShapeMatch Cutting Guide, used in knee replacement surgeries. The FDA issued a nationwide recall of this device due to software defects that resulted in inaccurate cutting guides. These inaccuracies have led to severe health complications, including joint instability, fractures, chronic pain, and the need for additional revision surgeries.
LFIT Anatomic CoCR V40 Femoral Head Lawsuits
Stryker’s LFIT V40 Femoral Head has also been the subject of numerous lawsuits. This device, recalled in 2016, has caused high levels of metal ions in patients’ blood, leading to metallosis and significant tissue damage. Many patients required revision surgeries to address these issues, and while some cases have been settled, ongoing litigation continues for unresolved claims.
Accolade V40 Lawsuits
The Accolade V40 hip replacement implant has prompted further litigation due to its premature failure and associated complications. Patients have reported issues such as metallosis, tissue damage, and severe pain, necessitating additional medical interventions and surgeries. These complications have led to numerous lawsuits as patients seek compensation for their suffering. We have not seen a newly filed lawsuit in this litigation in some time.