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Stryker LFIT Anatomic CoCr V4TM Femoral Head

Patients who had a hip replacement operation in the Pittsburgh and surrounding Ohio Valley areas and then suffered from serious complications, including pain, immobility, metallosis, and catastrophic hip failure, may be eligible to file a personal injury lawsuit.

The question is: Did your doctor use a component called the Stryker LFIT Anatomic CoCr V4TM femoral head? Some patients don’t know right away, but that’s okay. The Stryker hip lawyers at Chaffin Luhana can help investigate your case to find out.

Why does it matter? Because Stryker recently notified orthopedic surgeons that this particular component was potentially defective, especially if manufactured before 2011. In some cases, the femoral head actually disassociated from the stem, creating a medical emergency, with patients having to undergo extensive revision surgery.

The Pittsburgh lawyers at Chaffin Luhana are currently investigating cases in which the Stryker LFIT Anatomic CoCr V4TM femoral head failed to perform as expected, leaving patients facing additional surgeries as well as months of pain, suffering, and unexpected medical costs. Families may be able to recover these and other expenses in court.

What is the LFIT V40 Femoral Head?

It used to be that hip replacement devices consisted of only a couple parts, but that has changed in recent years. Now, most manufacturers create so-called “modular” systems that contain a number of smaller parts from which surgeons can choose. The goal is to create a more customized hip implant that is meant to improve function and fit in individual patients.

Today, hip replacement systems may include these parts and more:

  • Femoral head
  • Femoral stem
  • Femoral neck
  • Liner
  • Acetabular shell or socket

The Stryker LFIT V40 is a type of femoral head. This is the component that actually fits into the hip socket—or in the case of a hip replacement, the acetabular shell. You can imagine the hip joint as a ball-and-socket type of joint. When it wears out because of osteoarthritis, surgeons insert a new “stem” into the thigh bone (the femoral stem), attach the femoral head to the stem, and insert the head into the socket, or acetabular shell.

Stryker advertised its LFIT V40 femoral head as a component that would reduce the risk of problems, including dislocation, while maximizing movement and flexibility. They also assured doctors and patients that the materials used—cobalt and chromium—along with the technology used to design the component, would reduce risk of friction and corrosion.

Other hip implants made of metal materials—including Stryker’s Rejuvenate Modular and AGB II Modular-Neck Hip Stems—have been taken off the market because with wear and tear, they deposited metal fragments into the surrounding tissues of the joint, causing inflammation, pseudotumors, swelling, and subsequent joint loosening and ultimate failure.

The Stryker LFIT V40 femoral head was supposed to be of superior design, but recent reports have suggested that it, too, can shed metal fragments into the hip joint, creating damage that can lead to hip replacement failure and the need for revision surgery.

The Stryker LFIT Anatomic CoCr Femoral Heads are used with a number of hip implant femoral stems, including the following:

  • Stryker Accolade TMZF
  • Stryker Accolade 2
  • Meridian
  • Citation

Stryker LFIT V40 Femoral Head Increases Risks of Hip Failure

In 2014, a handful of patients filed hip replacement lawsuits in New Jersey state court alleging that the Stryker Accolade TMZF hip system—which includes the LFIT anatomic V40 femoral head—was defectively designed and manufactured.

These cases were filed about the same time as hundreds of other cases concerning Stryker’s Rejuvenate and ABG II hip replacement systems—which were recalled in 2012. But these few involved the LFIT femoral head, which had not yet come to the attention of most doctors as potentially problematic.

Plaintiffs claimed that these hip implant systems that included the LFIT V40 caused metallosis—a condition in which there are elevated levels of cobalt and chromium in the bloodstream—as well as inflammation, pain, and damage to the surrounding tissues and bone.

Then, in July 2016, another plaintiff filed a new lawsuit against Stryker in the U.S. District Court for the Southern District of New York. She alleged in her complaint that she had endured a catastrophic failure of her Stryker hip implant. She blamed it on the femoral head, which was part of the MDM X3 Mobile Bearing Hip System that she received.

It was only after these lawsuits were underway in court that Stryker warned doctors of the potential risks.

Stryker Warns Doctors of LFIT V40 Femoral Head Hazards

At the end of August 2016, Stryker sent doctors an “urgent medical device product field action notification” warning that the LFIT Anatomic CoCr V40 femoral heads manufactured prior to 2011 could be hazardous.

Specific problems associated with these components included, according to Stryker:

  • Disassociation of the femoral head from the hip stem
  • Fractured hip stem trunnion (area where the stem connects to the head)
  • Excessive metallic debris

They also reported that these hazards could create symptoms like loss of mobility, inflammation, dislocation, joint instability, pain, and more, and advised doctors to watch patients for these signs of problems. They asked doctors to check their inventory, and quarantine any remaining femoral heads “pending return to Stryker.”

Though this letter wasn’t seen as an official recall, because Stryker is asking for the devices to be returned, it is commonly referred to as the Stryker LFIT recall. As of this writing, consumers have not yet been notified of an official recall for the component.

Canada and Australia Warn of Stryker Femoral Head Defects

About the same time that Stryker sent its letter to orthopedic surgeons, Health Canada announced that the company had received “higher than expected complaints” of failures associated with the LFIT Anatomic CoCr V40TM femoral heads manufactured prior to 2011.

On September 27, 2016, the Australian government released a hazard alert warning consumers and health professionals of the risks associated with the Stryker LFIT femoral heads. They noted that failures related to this component could result in loss of mobility, pain, inflammation, dislocation, joint instability, and even broken bones around the component.

They advised consumers to be aware of the issue, and to contact their doctors should they experience any of these symptoms. In turn, they advised orthopedic surgeons to watch out for these hazards in their patients, and to report problems with the devices to the Therapeutic Goods Administration (TGA), Australia’s health products regulation group.

Studies Indicate Problems with Stryker LFIT V40 Femoral Head

In addition to the lawsuits and the government warnings, scientific studies have also raised concerns about the Stryker LFIT V40 femoral head, particularly when it comes to corrosion.

  • In a 2014 study, researchers noted that corrosion resulted in cases of pain, negative tissue reactions, pseudotumors (non cancerous growths), and osteolysis (bone destruction) around the hip implant. The corrosion was also noted to be a potential cause of “spontaneous disassociation” of the femoral head from the stem.
  • In a 2015 study, researchers described “trunnionosis” (corrosion between the metal surfaces at the head-neck connection) as a potential factor in causing pseudotumors and related hip-implant problems. They noted that “with at least one cobalt chromium component frequently present in hip arthroplasty prostheses, the incidence of this mode of adverse wear may be higher than previously thought….”
  • In a recent 2016 study, researchers describe nine cases of total hip implant failure related to metal wear debris around the “trunnion” (connection between the femoral head and stem). Doctors found elevated levels of cobalt and chromium in the patients, as well as tissue damage. They all had to go through revision surgery to fix the implant.
  • In a 2016 study review, researchers acknowledged that trunniosis was “a growing cause of total hip arthroplasty failure.” In some studies, it’s been reported to cause up to 3 percent of all revisions, and it’s believed to be caused by modular junction wear, corrosion damage, and metal ion release.

Types of Stryker LFIT V40 Femoral Head Injuries

When the Stryker LFIT V40 femoral head causes corrosion in the hip joint, the surrounding tissue is damaged and becomes swollen and inflamed. This causes the entire implant to loosen, and some of the components, including the femoral head, can weaken and become worn down.

Potential outcomes of this wear and tear include the following:

  • Catastrophic hip implant failure
  • Spontaneous disassociation of the femoral head from the stem
  • Metal poisoning
  • Pseudotumors
  • Tissue damage
  • Osteolysis (bone damage)

Patients who may be experiencing these dangerous changes in their hip implant may suffer the following symptoms:

  • Pain (sometimes severe)
  • Difficulty walking
  • Elevated levels of cobalt and chromium in the blood
  • Swelling and inflammation

The worst outcome is the spontaneous dislocation or “disassociation” of the head and the stem, it often creates an emergency medical situation, in which the patient requires immediate medical attention. This is where the implant actually breaks in the narrow area where the head connects to the neck.

Revision surgery is the only option when this occurs, and unfortunately, it’s often complicated and extensive. The doctor may have to remove the stem, which has usually grown into the bone at the time of surgery. Removal carries a risk of serious potential complications, including a fracture of the femur (thighbone). In rare cases, the femur has to be broken, the stem removed, and the femur put back together with wires and cables.

Meanwhile, the metal ions and fragments in the blood cannot be removed, and may continue to cause additional pain and swelling.

Pittsburgh Stryker LFIT V40 Femoral Head Lawyers Ready to Help

If you or a loved one received a Stryker LFIT V40 femoral head component as part of your total hip replacement system, and then experienced a catastrophic failure, or symptoms of loosening or metallosis, you may be entitled to compensation. Patients shouldn’t have to shoulder the costs for revision surgery, recovery care, lost wages, and more on their own.

Call today for a free and confidential case evaluation at 1-888-316-2311. Chaffin Luhana Pittsburgh attorneys represent individuals in West Virginia, Western Pennsylvania, and Eastern Ohio.

 

 

 

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