Stryker is a leading medical technologies firm known in part for its extensive line of hip replacement systems. However, in recent years, complaints about flaws in the company's metal-on-metal designs have led to recalls of several Stryker hip replacement devices, including the Rejuvenate® and ABG II®. In this article, we outline information about affected Stryker implants and what to do if you were harmed by a faulty Stryker hip replacement system.
Below, you'll find answers to your questions about Stryker implant injuries. If you have additional questions, or you wish to speak to someone about your specific situation, please contact our office today to schedule a complimentary initial case consultation.
Q: Which Stryker hip implant devices are associated with serious complications?
A: Several Stryker implants have been linked to serious complications in hip replacement patients. The company's Rejuvenate and ABG II modular-neck hip systems were recalled in 2012 after it was discovered that the metal-on-metal design promoted corrosion and fretting that released small metallic particles into the surrounding tissue and bloodstream.
Additionally, in 2016, Canada and Australia recalled Stryker's LFIT V40 Femoral Head® over concerns that it's prone to breaking free of the stem implant. The LFIT V40 Femoral Head was designed for use with Stryker's Accolade TMZF®, Accolade 2®, Meridian®, and Citation® hip stems. These problems may also plague other Stryker hip replacement systems and components, such as the Exeter®, Reliance®, Definition®, and Restoration®.
Q: What is a modular-neck hip stem?
A: Modular-neck hip stems are components of a multi-piece total hip replacement system. Unlike monoblock hip systems that have a single-piece neck and stem, modular-neck hip systems have interchangeable pieces in different sizes that allow doctors to match the appropriately-sized piece to their patient's anatomy. In addition to a more tailored fit, these modular-neck hip stems were also considered to be longer-lasting and give patients a better range of motion.
Q: What is a femoral head?
A: A component of a multi-piece modular hip replacement system, a femoral head is the rounded, ball-like piece that attaches to the top of the neck of the femoral stem. While some femoral head pieces are made of metal alloys such as cobalt-chromium, others are ceramic.
Q: Why did Stryker develop the Rejuvenate and ABG II systems?
A: Replacing hips can't follow a one-size-fits-all system, which is why Stryker developed multi-piece modular-neck hip stem hip replacement systems, such as Rejuvenate and ABG II. The components of these total hip replacement systems came in a variety of sizes, allowing surgeons to select those that more closely matched their patient's natural anatomy. Stryker's Rejuvenate and ABG II hip replacement systems were also designed to last longer than similar systems and offer patients a greater range of motion.
Q: Why did Stryker develop the LFIT V40 Femoral head?
A: Stryker developed the LFIT V40 Femoral head for the same reason it developed its modular Rejuvenate and ABG II systems: to give doctors the ability to provide their patients with a hip implant component that's appropriately sized for their anatomy. The LFIT V40 Femoral head was also thought to be stronger and more resistant to daily wear and tear.
Q: Have any of these implant devices been recalled?
A: Yes. Stryker's Rejuvenate and ABG II modular-neck hip stems have both been recalled in the United States. The company voluntarily recalled both modular-neck hip stems in 2012 after post-market research showed the systems' metal-on-metal designs made them prone to fretting and corrosion that could cause extensive health problems.
Q: Why were the Stryker Rejuvenate and ABG II modular-neck hip stems devices recalled?
A: Stryker voluntarily recalled its Rejuvenate and ABG II modular-neck hip stems devices in 2012 due to the discovery of a design flaw that had the potential to cause serious health problems. The company's Rejuvenate and ABG II hip replacement systems feature a metal-on-metal design that was prone to corrosion and fretting at the junction of the femoral head and stem. This fretting and corrosion allowed small metal particles to spread and accumulate in the body which can lead to metallosis, a dangerous form of metal poisoning.
Q: Has the FDA taken action to recall the Stryker LFIT V40 Femoral Head?
A: No. While the Stryker LFIT V40 Femoral Head was recalled in both Canada and Australia due to safety concerns, as of December 2016, it has not been recalled in the United States. However, some orthopedic experts suspect that a Food and Drug Administration (FDA) recall is forthcoming.
Q: How do I know if I have one of the problematic Stryker hip devices?
A: Patients may not know exactly which implants were used in their hip replacement surgery but, fortunately, this information can be easily obtained from your orthopedic surgeon. If you had a total or partial hip replacement surgery in the past several years, and are concerned that problematic Stryker components may have been used, talk to your doctor. The Stryker Rejuvenate and ABG II systems are affected, as are the Stryker LFIT V40 Femoral Heads used in conjunction with the Citation, Meridian, and Accolade systems.
Q: If I received one of these Stryker hip devices, do I need to have revision surgery?
A: Not all patients with Stryker hip implants will experience the adverse effects associated with failing devices. Still, revision—and even reconstructive—surgery may be necessary to remove a dangerous implant and correct any related damage. If you have questions about the safety of your Stryker implant, talk to your doctor.
Q: How can I tell if my Stryker hip implant is failing?
A: Here are some symptoms associated with faulty implants:
- Are you having trouble walking?
- Are you experiencing pain in the implant area?
- Do you notice a “slipping” sensation in the replaced hip joint?
If you have a Stryker hip implant and develop any of these symptoms, contact your doctor as soon as possible. Your doctor will be able to examine you and determine if your Stryker hip implant is failing, and what—if any—corrective actions and treatments are necessary.
Q: What symptoms are commonly associated with a failing Stryker hip stem?
A: According to the FDA, the symptoms of all-metal hip system failure include:
- Swelling in the hip or groin areas
- Pain in the hip area
- Severe pain when moving or walking
- Strange lumps in the tissue around the affected hip
- Dislocation (identified by a “slipping” feeling in the joint)
- Squeaking or popping sounds when moving
Q: What are the adverse side effects associated with a failing Stryker hip stem?
A: When a Stryker metal-on-metal hip stem starts to fail, there can be disastrous consequencesfor patients. A failing hip stem can loosen or dislocate; spontaneously break free of the femoral head; or cause infections, bone death, or metallosis—a type of metal poisoning caused by the accumulation of metallic particles in the body.
Q: What symptoms are commonly associated with a failing Stryker LFIT V40 Femoral Head?
A: The most common symptoms associated with a faulty Stryker LFIT V40 Femoral Head include swelling, inflammation, and severe pain. A failing Stryker femoral head can also cause:
- Difficulty walking
- Adverse skin reactions at the implant site
- Joint instability
- Elevated levels of metals in the bloodstream
If you have a Stryker LFIT V40 Femoral Head implant and experienced any of these symptoms, contact your doctor right away.
Q: What are the adverse side effects associated with a failing Stryker LFIT V40 Femoral Head?
A: If you have a failing Stryker LFIT V40 Femoral Head can cause numerous adverse effects. Some of the most serious are:
- Metallosis (metal poisoning)
- Tissue and bone damage
- Non-cancerous tumors
- Spontaneous disassociation (when the femoral head breaks free of the stem)
Any of these complications can lead to a series of other serious health issues, such as infections or loss of mobility.
Q: What is metallosis and how is it linked to Stryker hip implants?
A: Metallosis is a type of metal poisoning that can occur when metal particles and fragments accumulate in the blood, tissue, and bones. This is a common condition among hip replacement patients who had the recalled Stryker Rejuvenate and ABG II systems. One of the main reasons the company recalled the Rejuvenate and ABG II is because the systems' metal-on-metal components were found to deteriorate, corrode, and “fret” with wear, allowing toxic metal shavings to spread throughout the body.
Q: What are the symptoms of metallosis?
A: Patients with Stryker metal-on-metal hip replacement implants should watch out for the following symptoms, as they may indicate metal poisoning, also known as metallosis:
- Discoloration of the tissue at the surgical site
- Swelling and inflammation at the surgical site
- Severe pain in the replaced hip joint
- Loosening of the implant
- Sensory changes
- Impaired kidney function
- Skin changes
Contact your doctor if you experience any of these symptoms.
Q: Why are people filing lawsuits against Stryker?
A: More than 4,000 patients have filed lawsuits against Stryker, alleging the company failed to design its Rejuvenate and ABG II systems to resist fretting and corrosion. The lawsuits also allege that Stryker manufactured, marketed, and sold a defective product, and neglected to warn patients of the devices' high failure rates.
Q: What are the risks associated with revision surgery?
A: Patients with faulty Stryker hip implants may need two types of surgery to correct the problem: revision surgery to remove and replace the recalled implant; and reconstructive surgery to repair any damage caused by the defective device, such as necrotic tissue, broken bones, and other issues. Both of these surgeries are usually more painful and invasive than the original hip replacement surgery, and may require a longer recovery period. Also, patients who need additional surgeries subjects them to increased risks of infection.
Q: Who is Broadspire and what is their role in the Stryker Rejuvenate and ABG II hip implant recalls?
A: Broadspire is a third-party risk management company hired by Stryker to handle claims related to its Rejuvenate and ABG II recalls. A division of Crawford and Company, one of the world's largest insurance claims adjusters, Broadspire contacts claimants to ensure they were actually implanted with the recalled devices, and then offers reimbursement for out-of-pocket costs associated with the failed implants, such as doctor visits, lab work, revision or reconstructive surgeries, and rehabilitation.
Q: Why should I contact an attorney instead of filing a claim with Broadspire for reimbursement of my medical bills?
A: There are several reasons why patients with recalled hip implants shouldn't work with Broadspire without first consulting an experienced personal injury attorney.
For example, Broadspire was hired by Stryker to look out for the company and may not have your best interests in mind. Additionally, while Broadspire can reimburse patients for out-of-pocket expenses related to the recalled hip implants, it doesn't offer compensation for non-economic pain or suffering damages, such as disability, reduced quality of life, or emotional distress.
A settlement from Broadspire may provide much-needed financial relief, but it's important to note that these settlements are usually significantly less than what patients could obtain if they hire an attorney and take their case to court.
What should I do if my Stryker hip implant has failed?
A: First, talk with your doctor about what corrective measures are required.
- Will you need hip revision or reconstructive surgery?
- Will it be just one surgery or several?
- How long will your injuries and the corrective surgeries keep you out of work?
Once you have the answers to these questions, it's time to consult an experienced personal injury attorney who can discuss the details of your case with you and offer advice on how best to proceed. Also, if you're considering filing a lawsuit against Stryker, it's important to avoid signing any documents given to you by attorneys for the company until you've had a chance to review them with your legal counsel.
Q: Have Stryker Rejuvenate and ABG II hip implant lawsuits been filed?
A: Yes, thousands of patients have filed lawsuits against Stryker. These suits allege the company failed to properly test their Rejuvenate and ABG II hip replacement systems; warn patients of the risks of these devices; or respond to patient concerns. In 2013, Stryker settled the first four Rejuvenate/ABG II lawsuits for an undisclosed amount. In 2014, the company also agreed to pay $1.43 billion to settle an additional several thousand lawsuits.
Q: Have Stryker LFIT V40 Femoral Head lawsuits been filed?
A: Yes. Although Stryker has not issued a recall for their LFIT V 40 Femoral Heads, patients who've suffered serious injuries and side effects—such as taper lock failure—have already filed lawsuits against the company, alleging that Stryker failed to sufficiently test the devices or warn patients of associated risks.
Q: Is there a class action against Stryker?
A: No, there isn't a class action case against Stryker, nor is there one in the works. In 2013, the New Jersey Supreme Court consolidated Stryker Rejuvenate and ABG II Modular Hip Stem cases, designating them multidistrict litigation to be handled by Bergen County Judge Rachelle L. Harz. Multidistrict litigation promotes consistency by ensuring that similar cases are heard by an experienced judge in the same courtroom.
Q: How long do I have to file a Stryker hip implant lawsuit?
A: While the statute of limitations varies throughout America, in most states, victims have two years to file a personal injury lawsuit. In Stryker hip implant cases, this two-year period begins on the date the hip replacement systems were recalled; or the date you discovered there was a problem with your Stryker implant. Filing a lawsuit during the statute of limitations is extremely important. Potential plaintiffs who wait too long to file may risk having their case thrown out, simply because the statute of limitations had expired. Do you have a question about the statute of limitations in your state? Call McGartland Law today.
Q: How much does it cost to file a Stryker lawsuit?
A: The potential cost of filing a Stryker lawsuit is a common concern among hip replacement patients who fear they don't have enough money to take their case to court. Fortunately, most personal injury law firms handling Stryker hip replacement cases work on a contingency basis.This means you aren't billed until the case is resolved, which allows you to pay your attorney with money from your settlement, rather than paying for legal services upfront and out of pocket. To learn more about working on contingency, call the legal team at McGartland Law.
Q: How long will a Stryker lawsuit take?
A: The length of a personal injury lawsuit can vary dramatically, depending on the details of the case. Lawsuits can take days, weeks, months, or even years to resolve. If you're concerned about just how long your Stryker lawsuit could take, sitting down and discussing the details of the case with an experienced attorney should give you a better idea of what to expect.
Q: What damages can I recover in a Stryker lawsuit?
A: The damages that plaintiffs can pursue in a Stryker lawsuit are similar to those recoverable in other types of personal injury cases, such as compensation for medical costs related to the recalled devices—including doctor visits, treatments and revision surgeries—as well as lost wages for the time you missed from work and loss of earning capacity if the hip revisions will keep you out of work permanently. Patients can also seek non-economic pain and suffering damages related to loss of mobility, reduced quality or enjoyment of life, and more. For more information, contact the offices of McGartland Law.