Another Strike for Stryker: Your Guide to Stryker Hip Implant Recalls and Recoveries

Stryker hip implants have a history of high failure ratesYour goal was to get back to the activities that you loved. You wanted to participate fully in all aspects of your life, but your hip pain was getting in the way of your time with your family, your hobbies, and your work or retirement plants.

Recognizing that you didn’t have to live with the limitations of hip pain, you took action, you found a surgeon and you consented to hip replacement surgery. Now, you may be one of the people who have been hurt by a Stryker hip implant, and you may have questions about what this means about your rights and about your future.

Danger Associated With Specific Stryker Hip Implants

The Federal Drug Administration (FDA), Health Canada (Canada’s FDA equivalent), and the Australian Therapeutic Goods Administration (Australia’s FDA equivalent) have all raised concerns about certain Stryker hip implants. Additionally, Stryker Orthopaedics has issued a voluntarily recall.

FDA Recall

In July 2012, a recall was issued for two Stryker hip implants. Specifically, the following modular hip stems were recalled because of a concern about fretting and corrosion:

  • Rejuvenate®
  • ABG II®

Fretting and corrosion can result in…

  • A loosening of the hip implant.
  • Nerve damage.
  • Bone complications.
  • Metal poisoning, also known as metal toxicity.
  • Physical pain.
  • Other serious health problems.

The Stryker Rejuvenate and ABG II modular implant were designed using dissimilar metals. It was no surprise that these hip replacement systems started having problems and were recalled from the market within two years of being launched.

Stryker Recall

As of November 14, 2016 the FDA has not issued additional recalls. However, in August 2016, Stryker voluntarily recalled LIFT™ Anatomic CoCr V40™ Femoral Heads that were made prior to 2011. These metal products are the balls that attach to the hip stems in a hip replacement procedure. They have been used with Stryker hip implants, including the…

  • Accolade® TMZF®
  • Accolade 2®
  • Meridian®
  • Citation®
  • Exeter®
  • Reliance®
  • Definition®
  • Restoration®
  • Accolade Rejuvenate®
  • ABG 2®

Stryker issued the recall because the lock which could connect the LIFT™ Anatomic CoCr V40™ Femoral Head to the hip stem may fail or break and cause significant health complications, such as:

  • The femoral head separating from the hip stem.
  • Fractured hip stem.
  • Metal entering the bloodstream and resulting in metal toxicity.

Thus, the failure of the medical device can result in pain, dangerous falls, and life-threatening conditions.

Health Canada and Australian Therapeutic Goods Administration Action

In August 2016, Health Canada announced a recall of LFIT Anatomic COCR V40TM and COCR LFIT femoral heads, manufactured before 2011. This is not the first time that Health Canada has acted before the FDA on a Stryker hip implant recall. It also recalled Rejuvenate® several months before the FDA took action in July 2012.

In September 2016, the Australian Therapeutic Goods Administration also took action. While this agency did not issue a recall, it did issue a hazard alert to warn the public of the potential danger of seven models of the LFIT hip femoral heads with head diameters from 36 mm to 44 mm.

The safety alert warned patients and their surgeons that the failure of the LFOT femoral head could result in:

  • Loss of mobility.
  • Pain.
  • Inflammation.
  • Adverse local tissue reaction.
  • Dislocation.
  • Joint instability.
  • Broken bones.
  • Leg length discrepancies.

And it could result in the need for revision surgery.

As of March 2017, the FDA has not issued a similar warning, nor has it issued a recall. However, people in the United States who have these types of implants face the same risks as people in Canada and Australia.

Why Stryker Should Have Known Better

Stryker and other hip manufacturers knew long ago that using metal in certain hip replacement components was going to cause problems.

As long ago as 1993 a study was published indicating that hip replacement systems using titanium cobalt and chromium experienced corrosion. The results demonstrated that using metal alone or metal in combination with ceramic in hip replacement systems had a high risk of causing corrosion in the body. Additionally, the study showed that the corrosion increased the longer the components remained inside the patient’s body. The results showed that as much as 35% of some metal hip components corroded. Unfortunately, this didn't deter Stryker or other hip replacement manufacturers from using metal in hip components.

As recently as 2013, a medical journal article discussed the metal corrosion problems with Stryker’s Rejuvenate hip systems. The article found that due to the restricted environment in which the hip replacement sits, it is exposed to movements and stresses that cause the oxide films to fracture. The tapered head of the device that connects the ball onto the net is prone to corrosion from the way the body and components move. It was believed that the two metal alloys of cobalt and chromium were resistant to corrosion in the body. This, however, proved to be false because corrosion was witnessed in the head-neck taper where the titanium or cobalt-chromium neck contacts the cobalt-chromium femoral head.

How to Know If You Have a Recalled or Defective Hip Implant

It can be scary to read the information above and to wonder whether you have a defective implant already in your body. Accordingly, it is important to:

  • Check the FDA website regularly for updated recall and safety alert information.
  • Monitor the news to find out about voluntarily recalls or action taken in other countries.
  • Contact your surgeon. Find out exactly what was used in your surgery.

Additionally, it is important to be aware of hip implant failure symptoms and get to the doctor as soon as you experience any symptom of concern.

Symptoms of Hip Implant Failures and Complications

Symptoms of metal toxicity include:

  • Impaired kidney function or kidney failure.
  • Hearing problems or visual disturbances.
  • Weakened or enlarged heart (cardiomyopathy).
  • Thyroid problems such as weight gain, fatigue, neck pain, or loss of sensation.
  • Psychological problems, including depression, paranoia, or cognitive disability.
  • Rashes or skin color changes.

Symptoms of other problems include:

  • Swelling.
  • Pain.
  • Loss of mobility.
  • Weakness.
  • Noises coming from the hip implant.

Once you recognize the risks and the symptoms of a problem then you can develop a plan to protect your health.

But What If There Are No Symptoms?

Fortunately, the FDA has released a set of guidelines to follow to help determine if your metal hip replacement components are causing you harm by poisoning your body.

One of the FDA guidelines deals with soft tissue imaging. This type of imaging study will help determine if there are metal artifacts present in the area surrounding your hip. Metal artifacts are simply large pieces of metal created when friction causes metal debris to shed from the hip implant. A doctor or radiologist can tell if you have metal artifacts because the imaging will be distorted due to the presence of the metal pieces.

Your surgeon may order an MRI, CT scan, or ultrasound to test for metal artifacts. The MRI is typically considered the gold standard for this type of test. If you are able to have an MRI performed, the FDA recommends an MRI with Metal Artifact Reduction (MARS). This addition of MARS makes the MRI much more reliable and easier for the radiologist to determine if you have metal debris from the hip implant. If an MRI isn't available for you, then a CT scan can be used to determine if your implant is still properly positioned. The CT scan, although typically not as sensitive as an MRI, can also indicate the presence of metal by being distorted. Ultrasounds are less likely to produce valuable information, but they are a viable alternative if you cannot have an MRI or a CT scan.

Blood tests may also be useful in detecting smaller pieces of metal that can cause catastrophic injuries even if they can’t be seen in imaging studies. Blood is often tested using an ICP-MS (inductively coupled plasma mass spectrometer) at a CLIA-certified lab (Clinical Laboratory Improvement Amendments). Specifically, blood should be tested for the presence of cobalt, chromium, and titanium.

Revision Surgery May Not Be the Answer

If you facing a revision surgery for a failed component, then it is important to ask your surgeon many questions about why the device failed and what new device is going to be implanted in its place.

Hip revision surgery may be medically necessary, but it may not erase the significant damage that you have suffered. Revision surgeries still have all of the risks of regular hip replacement surgeries, which include the risks of suffering:

  • An adverse reaction to the anesthesia.
  • A heart attack.
  • Excessive bleeding.
  • Blood clots.
  • Infection.

A revision surgery can also result in additional risks. This type of surgery may be more invasive and challenging than an initial hip replacement surgery, because the defective hip replacement must be removed and there may be damage that makes implanting a new hip replacement more difficult. Even with surgery, damage to soft tissues, bone, and muscle may be inevitable.

Why People Are Suing Stryker

Many cases against Stryker allege that the manufacturer willingly released a defective product into the marketplace, while others claim that the design of the implant was faulty and should have been corrected before manufacture.

Stryker hip replacement lawsuits specifically raise a number of claims, including:

  • The device was not properly tested before being made available to the public.
  • The device was marketed as a “perfect fit” for young patients, giving doctors and patients a false security in its use for minor patients and an undeserved preference above other devices.
  • The synthetic joint has a tendency to corrode, deteriorate, and fail before the industry average length of use.
  • The manufacturer did not adequately warn doctors and patients about potential harmful side effects, such as metal toxicity and bone fractures.
  • The nature of the system makes it likely to release heavy metals into recipients’ bodies.
  • The manufacturer was aware—or should have been aware—that the product was inherently more dangerous than similar devices because of its premature failure rate.
  • The manufacturer chose to market the device without properly informing consumers about its particular risks.

The purpose of these lawsuits is to award compensation to injured victims who will likely need to undergo additional procedures and unnecessary pain and suffering. If successful, these victims can also hold the manufacturer accountable for its mistakes, preventing them and other disreputable companies from putting consumers at risk.

Filing Your Lawsuit

If you have been hurt by a defective Stryker hip implant, then you may have the right to file a lawsuit. As of November 2016, there is not a class action case pending against Stryker. However, there is multidistrict litigation pending and state courts also have consolidated cases. Multidistrict and state court consolidation of cases helps ensure that lawsuits are heard efficiently and that court rulings are consistent.

Do not trust Stryker to settle a claim with you fairly; instead, contact an experienced attorney who can make sure that all of your rights are protected and that you get the fair recovery that you deserve. Fair damages may include compensation for past and future physical pain, emotional suffering, loss of enjoyment of life, lost income, hospitalizations, medications, doctors’ appointments, rehabilitation costs and any other expenses that are directly linked to complications from a defective hip replacement.

Your time to file a case is limited by law. It is therefore important to take action as soon as possible.

We were committed to helping people injured by Stryker hip replacement products after the 2012 FDA recall, and we continue our commitment today by helping those who have been hurt. Please contact us today to find out more about your rights and about how we may be able to help you with your recovery.
 

Matthew L. White
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Founder & Partner of Louisville Personal Injury Law Firm Gray & White Law