Stryker Orthopaedics has produced several metal-on-metal (MoM) hip implants that do not function as they should, leading to massive recalls and lawsuits. Stryker is the manufacturer behind the Rejuvenate and ABG II hip stems, both of which were recalled.
Stryker has produced metal-on-metal (MoM) hip implants that do not function as they should, leading to massive recalls and lawsuits.
In the fall of 2014, Stryker agreed to pay $1.43 billion to settle thousands of lawsuits concerning its ABG II and Rejuvenate hip stems. Under the settlement, each plaintiff could receive as much as $600,000 in damages.
Now, Stryker’s V40 femoral heads (which are used in MoM hip replacements) appear hazardous enough to warrant an alert from the company warning against potential side effects, such as loss of mobility, pain, inflammation, and dislocation.
If you received a Stryker hip implant and have experienced unforeseen side effects, and you require(d) revision surgery as a result, please contact us today to learn your rights. You may qualify for a lawsuit that could help you pay medical bills and other expenses related to your Stryker device.
About the Stryker Corporation & Stryker Orthopaedics
Dr. Homer Stryker founded The Orthopedic Frame Company (which would become the Stryker Corporation) in his hometown of Kalamazoo, Michigan in February 1946. Dr. Stryker was an orthopedist and inventor who developed the mobile hospital bed, the oscillating saw (a cast-cutting device), and the walking heel, among other key innovations.
In 1977, his company went public. In 1979, it acquired the Osteonics Corporation, which manufactured hip, knee, and other orthopedic replacements. Dr. Stryker passed away the following year, in 1980, at the age of 85. His children and grandchildren would continue to steer the company.
In 1998, Stryker acquired Howmedica, Pfizer’s orthopaedic division, and renamed it Stryker Orthopaedics. (This is one of about two dozen major acquisitions the company has made over the past 20 years.) In 1999, Stryker Corp. annual sales surpassed the $2 billion mark. In 2002, they topped $3 billion. In 2005, nearly $5 billion.
By 2015, Stryker Corp. employed more than 20,000 people worldwide and generated annual sales of $10 billion.
Metal-on-Metal Hip Implants Have “Unique Risks”
The trouble with metal-on-metal (MoM) hip implants is that when the metal ball and socket rub against each other, metal particles can be released into the bloodstream, leading to cobalt chromium poisoning. For that reason, many orthopedics companies have ceased production of MoM implants.
Moreover, health agencies around the world have expressed concern with these implants.
In the spring of 2010, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) issued a warning about MoM hip replacements. In this alert the MHRA advised patients to get blood tests and imaging to ensure they didn’t have metal poisoning. Two years later, the MHRA issued a follow-up with guidelines on monitoring and caring for MoM hip patients.
In 2012, Health Canada issued an alert containing important safety information for MoM hip replacement surgeons and patients. This alert noted:
In recent years, there has been an increase in awareness of pain, implant loosening and significant soft tissue reactions thought to be the result of increased levels of metal (cobalt and chromium) ions in the surrounding joint tissue. Soft tissue reactions can range from fluid collection to more extensive necrotic and “pseudotumor” reactions and can necessitate device revision.
Health Canada also reported that “14.2% of revised MoM hip implants exhibited soft tissue reactions.”
Furthermore, the U.S. Food and Drug Administration (FDA) states on the Metal-on-Metal Hip Implants section of its website, “Metal-on-metal (MoM) hip implants have unique risks in addition to the general risks of all hip implants.”
The FDA advocates the following measures for any patient experiencing symptoms that suggest their implant is not functioning as it should:
- Joint aspiration (removing fluid from around the joint)
- Soft tissue imaging
- Blood tests, including checking metal ion levels
The FDA adds that MoM patients should be extra-aware of their general health, as some medical literature suggests MoM hip implants can lead to systemic reactions elsewhere in the body.
Among these potential reactions are skin rash and hypersensitivity, cardiomyopathy, neurological changes, renal function impairment, depression or cognitive impairment, and thyroid dysfunction.
Stryker Issues Accolade V40 Hazard Alert
In October 2016, Stryker Orthopaedics issued a hazard alert warning doctors and patients of potential side effects that may be caused by seven models of Stryker V40 femoral heads, which are used in metal-on-metal (MoM) hip replacement procedures.
The side effects outlined in the Stryker alert include the following:
- Loss of mobility
- Adverse tissue reaction
- Joint instability
- Broken bones
- Leg length discrepancy
- Need for revision surgery
Though the alert is not technically a recall, it could certainly discourage surgeons and patients from pursuing total hip replacements that include a Stryker V40 femoral head.
The Accolade V40 has been recalled in Canada and Australia. Still, there are an estimated 44,000 hip implants (globally) that utilize this potentially defective femoral head.
Stryker Settles Hip Implant Lawsuits for $1.4 Billion
In 2012, Stryker recalled two metal hip implants, the Rejuvenate Modular and the ABG II Modular-Neck hip stems. The company did so over concerns that the parts could fret or corrode, resulting in pain, swelling, and inflammation in the surrounding tissue.
Stryker agreed to pay $1.43 billion to settle lawsuits concerning its ABG II and Rejuvenate hip stems.
The recalled neck stems allegedly caused serious health problems such as pain and inflammation, premature hip implant failure, and metal poisoning—which can lead to systemic issues affecting the heart, nervous system, and thyroid.
The 2012 Stryker recalls spawned lawsuits from thousands of patients, many of whom would have to undergo yet another difficult surgery and recovery due to a defective implant.
In the fall of 2014, Stryker agreed to pay $1.43 billion to settle lawsuits concerning its ABG II and Rejuvenate hip stems. Under the settlement, each plaintiff could receive as much as $600,000 in damages.
In a similar lawsuit in December 2016, a Texas jury awarded $1 billion to six plaintiffs who needed revision surgeries because of painful side effects caused by their DePuy Pinnacle hip implants. (DePuy is a division of Johnson & Johnson.)
Hold Stryker Accountable
If you or a loved one has experienced metal poisoning, dislocations, pain, inflammation, or broken bones because of a faulty hip implant, and require(d) revision surgery as a result, please contact us today to learn your rights.
You may qualify for a lawsuit that could help you recover medical bills, lost wages, and other expenses related to your device’s unforeseen side effects.