Stryker Hip Replacements: Failures, Recalls & Safety Concerns

Stryker hip replacements, especially the LFIT V40 femoral heads and certain adjustable parts like the Rejuvenate and ABG II, have had safety concerns because of problems in their design and materials. These issues can lead to serious hip replacement complications such as corrosion, harmful metal buildup in the body and wear and tear of the replacement parts.

Metal-on-metal (MoM) hip implants like the recalled Stryker implants, have a high failure rate. They often become loose, increasing friction that may lead to many issues, including metallosis. Metallosis is a type of metal poisoning that happens when the surfaces of the implants wear down over time.

Stryker LFIT V40 Corrosion and Metallosis

Stryker’s LFIT V40 taper system combined cobalt-chromium (CoCr) femoral heads and titanium alloy stems. This pairing can cause a problem called galvanic corrosion, leading to faster wear of the components. It led to a 2016 recall of more than 42,000 units manufactured before March 2011.

A 2014 study in the Journal of Arthroplasty found that material loss from the CoCr heads could reach 4.3 cubic millimeters, primarily due to corrosion between the parts.

Lawsuits claimed that the Stryker LFIT V40 experienced higher-than-average taper lock failure, which is when the implant fails at the hip joint because the femoral head has gotten loose. This can lead to problems like tiny metal particles and ions being released, which may cause metallosis.

Metallosis can damage bone and other tissue near the implant, potentially leading to severe conditions like tissue damage or death.

Stryker ABG II and Rejuvenate Hip Implants

A global Stryker hip implant recall affected the company’s ABG II and Rejuvenate Modular Hip Systems in 2012 due to risks of fretting (tiny shards of metal entering the bloodstream, tissues and bones) and corrosion at the modular neck junction.

This caused tissue reactions, pain, swelling or bone loss, potentially requiring revision surgery — removing and replacing the joint. Patients with these implants had to be monitored closely, especially if experiencing pain or swelling. Surgeons and healthcare providers were told to follow up with affected patients.

Faulty MoM implants can cause localized issues like pain, lowered mobility and inflammation. This inflammation may harm nearby soft tissues and ultimately result in the implant’s failure.

These local complications can escalate if left unaddressed, and metal ions may enter the bloodstream, triggering widespread health effects.

Studies looking for links between metallosis and cancer have had mixed results.

It’s important to catch metallosis symptoms early on. See a doctor immediately if you have these issues.

When your doctor looks for problems with the implant or signs of metallosis, they may order X-rays or other imaging and blood tests.

If your MoM hip fails due to metallosis, the only treatment is revision surgery. This involves removing and replacing the defective implant with a new hip replacement.

The FDA’s fast-track approval process, the 510(k) Premarket Notification Process, allowed Stryker’s hip implants to reach patients without extensive safety testing. As failures mounted, regulators tightened restrictions, and lawsuits followed. Increased oversight and legal action ultimately forced companies to abandon metal-on-metal hip replacements in the United States.

FDA Actions & Safety Regulations

Stryker opted for a quicker FDA 510(k) fast-track process to win approval for the Rejuvenate and ABG II devices. With this approval route, companies only need to show that their medical device is similar to an existing one in the U.S. Extensive clinical trials aren’t required.

High failure rates and serious health problems from metal-on-metal (MoM) hip replacements made by several different manufacturers were reported frequently in the 2010s.

In February 2016, the FDA required companies to stop selling these devices unless they received special approval, effective May 2016. This lengthy and challenging approval process helps ensure the implants are safe and effective.

There are no FDA-approved MoM total hip replacement devices in the U.S., but there are two approved metal-on-metal hip resurfacing devices.

Lawsuits, Settlements & Global Responses

In addition to referencing the adverse effects of MoM implants, lawsuits claimed that Stryker knew that the combination of metals used in these devices, TMZF titanium alloy and cobalt-chromium, had caused issues with earlier products. Stryker hip replacement lawsuits claimed that the company continued using these designs despite their knowledge.

Stryker lawsuits over injuries from the ABG II and Rejuvenate hips were consolidated into multidistrict litigation (MDL) in 2013. MDLs consolidate several similar lawsuits into one to make the legal process more efficient.

Cases over the Stryker LFIT V40 taper device were combined in a separate MDL in 2017.

Those who underwent hip replacement surgery before May 18, 2016, may have received a metal-on-metal implant. Your doctor should be able to tell you for sure.

If you have a Stryker or another brand of metal-on-metal hip implant, it’s important to have regular check-ups with your orthopedic doctor. Early detection can help avoid significant complications or the need for additional surgery later on.

If your symptoms get worse, reach out to your surgeon right away. Getting help can prevent severe problems, ensure your implant works appropriately and keep you healthy.

Online Resources for People With Metal-on-Metal Hips

The FDA and many other agencies, hospitals and non-profits provide information for patients with MoM implants. If you are unsure if you received a metal-on-metal hip implant or have any questions, please consult your doctor.