In June 2012, medical device manufacturer Stryker recalled two artificial hip implant products. This voluntary withdrawal came after the US Food and Drug Administration (FDA) received numerous adverse event reports from injured patients. The recalled implants include the Rejuvenate and the ABG II systems from Stryker’s THR (total hip replacement) line. After the global Stryker hip recall, the FDA issued their own warning about metal-on-metal orthopedic implants. Unfortunately, like many FDA product safety warnings, by the time they issued a statement, thousands of patients were already injured.
FDA Convenes Safety Panel During First Stryker Hip Recall
The FDA typically announces a device or drug recall is when it’s determined to be either defective or potentially harmful. Some companies preemptively withdraw their devices, like the Stryker hip recall involving the ABG II and Rejuvenate systems. Other times, the FDA intervenes in order to protect American consumers.
Due to a series of recalls involving metal-on-metal implants, the FDA hosted a June 2012 panel regarding patient safety. The hearing allowed surgeons and researchers to educate the public about potential complications and injuries linked to metal-on-metal hip implants. Because several device manufacturers issued voluntary market withdrawals, the FDA didn’t issue a ban or blanket recall. However, many panel members called for additional post-market safety studies on artificial hip and knee replacement systems. They also recommended doctors inform patients about potential metal-on-metal implant problems.
Metal-on-Metal Implants More Dangerous Than Others, Says FDA
Afterwards, the FDA published the panel’s findings, including risks from metal-on-metal implants. (These are the same complication risks that triggered the voluntary Stryker hip recall that month.) The document states: “All artificial hip implants carry risks including wear of the component material.” Because hip replacements are foreign objects surgically implanted to replace a functional body part, wear and tear is normal. But the FDA specifically warns against metal-on-metal implants due to increased injury risks compared to other artificial hips.
They explain that physical activity with a metal-on-metal implant causes the metal ball and cup to rub against one another. These two pieces regularly grating together releases metallic debris into the bloodstream as well as surrounding tissue. Doctors performing revision surgeries often discover wear and corrosion between these two metal-on-metal components. The longer such grinding happens, it releases more metal ion particles that can damage bone and/or tissue surrounding the implant. This condition is called an “adverse local tissue reaction” (ALTR) or an “adverse reaction to metal debris” (ARMD).
This complication typically requires revision surgery to fix. Surgeons must remove the old implant and replace it with a new one. Unfortunately, revision surgery comes with additional risks because it’s often more complex than the initial total hip replacement surgery. The complication risks are especially high for older patients, who may have a longer and more painful recovery.
The Stryker Rejuvenate and ABG II system implants are listed on the FDA’s 2016 medical device recalls.
Understanding The Dangers of Stryker Hip Implants
The two THR systems included in the 2012 Stryker hip recall aren’t typical metal-on-metal implants. Stryker manufactures its modular device necks using a proprietary blend of cobalt and chromium, then coats them with titanium. This process supposedly makes Stryker devices corrosion-resistant. Preventing corrosion helps protect patients from toxic ions and debris, which are often released when metal components grate together.
This very issue led to the voluntary Stryker hip recall in 2012. And in 2016, the company issued yet another Stryker hip recall involving LFIT V40 Femoral Head implants. Corrosion and “fretting” are two major risk factors for developing metallosis, or metal poisoning. According to Stryker’s 2016 Urgent Field Safety Notice, this risk also includes excessive metallic debris.
But metallosis symptoms, though terrible, aren’t the only reason for concern. Other injuries listed in FDA adverse event reports include:
- Disassociation of femoral head from hip stem
- Fractured hip stem trunnion
- Insufficient soft tissue tension
- Loss of implant: bone fixation strength
- Excessive wear debris
- Implant construct with a shortened neck length
Another possible complication from excessive metal debris in the joint space is osteolysis, also known as bone loss. In addition to those risks, any patients with metal sensitivity may suffer a severe and dangerous allergic reaction after implantation.
“Given the potential risks associated with fretting and corrosion at the modular neck junction, Stryker Orthopaedics decided to take this voluntary action,” said Stuart Simpson, Vice President and General Manager of Hip Reconstruction in a statement about the Stryker hip recall.
What the Stryker Hip Recall Means for Currently Implanted Patients
The company’s 2012 Stryker hip recall notified healthcare professionals about the device’s dangers. However, the FDA urges anyone with a Rejuvenate or ABG II modular-neck stem to contact a surgeon about revision options. Patients implanted with the LFIT Anatomic CoCr V40 Femoral Head are also affected by a May 2016 Stryker hip recall. If you had orthopedic surgery but don’t know the brand of implant used, it’s probably listed in your medical records. Don’t wait until you’re already suffering painful side effects to speak with your doctor about implant revision surgery. By then, it may be too late and you could develop life-threatening complications from a defective Stryker hip implant.
What You Can Do
If you or a loved one have a metal-on-metal implant from the Stryker hip recall, you may qualify for compensation. In fact, Stryker set aside $1.4 billion to settle multiple class action lawsuits against these defective total hip replacement systems. Unlike many mass torts, plaintiffs are encouraged to present their individual circumstances in order to qualify for different settlement levels. The base settlement is set at $300,000 per hip, but may increase depending on the plaintiff’s specific complications.
Think you may have an eligible Stryker hip recall claim? Learn about Stryker hip recall lawsuits and get your free claim evaluation today. An attorney in your area who’s familiar with Stryker hip recall litigation will contact you to discuss your case.
Mandy Voisin
Mandy Voisin is a freelance writer, blogger, and author of Girls of the Ocean and Star of Deliverance. As an accomplished content marketing consultant, mom of four and doctor's wife, Mandy has written hundreds of articles about dangerous drugs and medical devices, medical issues that impact disabled Americans, veterans' healthcare and workers' compensation issues since 2016.