Stryker LFIT V40 femoral heads have caused severe injury and inconvenience to patients who had the device surgically implanted to improve their hip mobility.
The device was intended to alleviate discomfort associated with rheumatoid arthritis, non-inflammatory degenerative joint disease (such as osteoarthritis and avascular necrosis), femoral neck fractures, and deformity correction. LFIT stands for low friction ion treatment and is intended to allow for reduced friction and less wear with all components of the device.
For a full hip replacement, the V40 is used in conjunction with the following hip stems.
- ABG II Monolithic Femoral Stem
- Accolade® TMZF Femoral Stem
- Accolade II® Femoral Stem
- Citation TMZF HA Stem
- Exeter® V40™ Femoral Stem
- Hipstar® Femoral Stem
- Meridian® PA Femoral Stem
- Rejuvenate® Monolithic Stem
- Reliance® PF Femoral Stem
- Restoration™ Femoral Hip Stem
What is wrong with the V40 femoral head?
Structure of the artificial hip joint.
There were a total of eight sizes of the V40 femoral head that were affected. LFIT V40 femoral heads manufactured between 2001 and 2011 were found to have contributed to taper lock failure in a number of patients who filed complaints with the company.
Taper lock failure occurs when the femoral head connected to the femoral neck becomes compromised, resulting in excruciating pain.
The potential harms from taper lock failure include:
- Loss of mobility
- Pain
- Inflammation
- Adverse local tissue reaction
- Dislocation
- Joint instability
- Bone fractures around the components
- Leg length discrepancy
- Need for revision surgery
Furthermore, the metal components can rub up against each other, causing high levels of metal to drift into the bloodstream known as metallosis.
Symptoms of metallosis:
- Rash
- Neurological and psychological changes
- Thyroid issues
- Cardiomyopathy
- Fatigue
A woman in Massachusetts filed a lawsuit against Stryker after contracting metallosis from a V40 femoral head.
She received a hip replacement device during surgery in 2007 that included the V40 femoral head. She experienced extreme discomfort around her hip joints following surgery. Though testing came back negative for infection, there were high levels of metal in her bloodstream.
Further testing indicated she would need revision surgery to remedy the problem. Her doctor concluded her symptoms were directly related to metallosis from the hip replacement. She also had trunnionosis (corrosion) in her hip joint which caused extensive soft tissue damage to the compromised site.
Her story is similar to many of the Stryker lawsuits that have been consolidated into multidistrict litigation in Massachusetts. Hip replacement is already a major surgery. It requires weeks of healing, so undergoing yet another surgery to replace the device is a major inconvenience and can have a big impact on one’s work and personal life.
The LFIT V40 is not an isolated incident. Another Stryker hip replacement product, Rejuvenate, was taken off the market when the ceramic component of the device was found to deteriorate and put users at risk of contracting metallosis.
Voluntary Recall
In August 2016, Stryker Corporation issued a field action notice stating they received higher than usual complaints about V40 femoral heads in patients who had the device implanted in their body. Thousands of implants were subsequently recalled due to taper lock failure.
That same month, Stryker sent out a recall letter to patients who had the V40 implanted. The recall letter outlined the following hazards of the device:
- Disassociation of femoral head from hip stem
- Fractured hip stem trunnion
- Excessive metallic debris
- Insufficient ROM
- Insufficient soft tissue tension
- Noise
- Loss of implant: bone fixation strength
- Excessive wear debris (polymeric)
- Implant construct with a shortened neck length
Those hazards could manifest into the following patient harms:
- User annoyance
- Loss of mobility
- Pain requiring revision
- Inflammatory response
- Adverse local tissue reaction
- Dislocation
- Joint instability
- Revision to alleviate hazardous situation
- Pain associated with implant loosening
- Periprosthetic fracture
- Leg length discrepancy
In November 2016, the Food and Drug Administration issued a Class 2 device recall on the V40 for posing temporary or medically reversible adverse health consequences.
The first bellwether case for the V40 femoral lawsuit head will take place in September 2019.
Stryker is based out of Kalamazoo, Michigan and pulls in billions of dollars each year with its products. The company specializes in joint replacement implants in trauma surgeries and typically markets directly to doctors and healthcare facilities. Since the consumer market is not Stryker’s target audience, it is important for physicians to be fully aware of the complications associated with the devices they use during surgery.
Questions about a Stryker Hip Replacement Lawsuit? Contact a Johnson//Becker Lawyer for a Free Case Review.
If you or a loved one have experienced any of the aforementioned complications following hip replacement surgery where a Stryker LFIT V40 femoral head was used, you may want to speak with the lawyers at Johnson//Becker. We are currently accepting new hip replacement lawsuits across the country, and you may be entitled to financial compensation.
We offer a Free Case Evaluation. Please contact us using the form below or by calling us at (800) 279-6386.
We would be honored to speak with you and respond promptly to every inquiry we receive.
Free Case Evaluation
To contact us for a free review of your potential case, please fill out the form below or call us toll free 24 hrs/day by dialing: (800) 279-6386.