Biomet Hip Replacement: Complications & Controversies

The Biomet Magnum metal-on-metal hip implants had an issue with early wear and tear. This breakdown releases harmful metal particles, causing adverse tissue reactions and higher metal levels in the blood. The increased risk of implant failure resulted in revision surgeries and lawsuits against Biomet. Following this, there has been a decline in metal-on-metal hip devices in the U.S.

The Link Between Biomet Hip Implants & Metallosis 

Metal-on-metal hip implants — including those made by Biomet — can sometimes cause a problem known as metallosis. Daily activities like walking or running create friction in the implant’s metal parts. The friction releases small metal particles into the nearby tissues, which can build up over time. This buildup of metal particles is metallosis.

Metallosis can develop even when the surgery is performed correctly, and it is not always easy to predict who will experience it.

Metallosis and other issues with MoM implants have led to more people needing follow-up hip surgeries to remove and replace faulty implants. These failures may affect patients for years after their initial surgeries.

What Did Biomet Know About These Risks?

Several developments suggest Biomet should have taken action as its M2a metal-on-metal hip replacements failed more often than expected.

While it’s unclear what Biomet knew before selling these implants, many problems became apparent only after years of use.

Research on Biomet’s metal-on-metal hip replacements revealed serious complications. These findings on Biomet and other MoM devices led the U.S. Food and Drug Administration (FDA) to enforce stricter safety regulations. Ultimately, these rules forced Biomet and other companies to withdraw the devices from the market.

What Studies Have Found About Biomet Metal-on-Metal Hip Replacements

Research on Biomet hip replacements revealed serious issues, like unexpected failure rates and metallosis.

Recent research on metal-on-metal (MoM) hip implants has revealed other risks, such as tissue damage and cancer.

Why Did the FDA Issue Metal-on-Metal Hip Warnings?

The FDA and health officials around the world raised alarms about Biomet’s metal-on-metal hip implants because of serious safety issues. These concerns were part of a larger problem affecting many similar hip devices in the industry.

In February 2016, the FDA issued a ruling requiring manufacturers of metal-on-metal total hip implants to stop selling their products unless they obtain FDA approval. To get this approval, they must prove that their implants are safe and effective. Any changes to the implants or their manufacturing also need FDA approval and annual reporting to keep the FDA updated.

Biomet and other MoM hip manufacturers issued recalls and withdrew these products from the market. They also stopped manufacturing metal-on-metal implants.

In 2022, a federal appeals court upheld a $3.55 million jury verdict against Biomet over a faulty M2a Magnum hip implant. Lori Nicholson of Fort Dodge, Iowa, had filed the original lawsuit nearly a decade earlier. The original implant failed after just four years.

Gymnast Mary Lou Retton — a 1984 Olympic Gold Medalist — was a spokesperson for the Biomet M2a Magnum hip implant. But after her own implant failed, she joined others suing the company.

Thousands of people filed lawsuits against Biomet, claiming that these implants caused them harm. The Judicial Panel on Multidistrict Litigation combined about 2,800 of those lawsuits in a multidistrict litigation (MDL). MDLs consolidate similar lawsuits to speed up the court process.

In January 2014, plaintiffs settled with Biomet over its M2a Magnum MoM implants. The settlement agreement covered all cases pending in the Biomet MDL and any future cases filed in federal court by April 15, 2014.

Under this settlement, patients who had their Biomet hip replaced at least 180 days after their initial surgery could receive payments starting at $200,000. However, the final amount could be lower based on certain factors, such as how long the implant had been in place or when they first received it. For example, some people received only $20,000, especially if their implant had been in place for over 10 years or was a different model from Biomet.

The United States District Court of the Northern District of Indiana closed the Biomet MDL in 2022.

Medical device maker Zimmer acquired Biomet in June 2015. Since then, Zimmer Biomet has transitioned to new materials following the metal-on-metal hip era. The company is also engaged in an FDA-mandated study of MoM hip problems. Zimmer Biomet now offers hip implants “designed to safeguard against cement and metal sensitivities” to enhance patient safety.

Zimmer Biomet designed its latest Z1 Triple-Taper Femoral Hip System to treat a broader range of patients. The company also uses advanced technology, such as AI and mixed reality, to improve hip surgeries and reduce complications.

Zimmer Biomet Metal-on-Metal Explant Study

The Zimmer Biomet Explant Study is part of a broader effort by the FDA to ensure that metal hip implants are safe for patients. The FDA required Zimmer Biomet and other companies to study failed implants removed from patients to understand their performance and potential risks better.

Zimmer Biomet Pulls Another Hip Implant Over Fracture Risk

Since the MoM hip controversy, research has linked another Biomet hip device to significant complications. The Zimmer Biomet CPT Hip System Femoral Stem has a high risk of thigh bone fractures after surgery. According to the FDA, an analysis in the United Kingdom found that the implant has a fracture rate of 1.4%, higher than similar implants, which usually have fracture rates of 0.6% to 1%.

In response, Zimmer Biomet issued a voluntary recall in July 2024, updating its instructions for use and phasing out sales by December. The FDA and U.K. regulators advised limiting its use and considering alternative implants. Both agencies continue to monitor the situation to protect patients and ensure safer hip replacement options.

The FDA recommends routine follow-ups every one to two years for patients with metal-on-metal hip implants. These should include physical exams, radiographs and checks for systemic complications. Symptomatic patients may need more frequent evaluations (at least every six months), metal ion testing and imaging.

If you had hip replacement surgery before May 18, 2016, you might have received a MoM implant. The FDA provides essential information for people who have this kind of implant. If you’re unsure whether your implant is metal-on-metal or have any questions, it’s a good idea to talk to your doctor.

How to Tell if Your Biomet Hip Implant Is Failing

Several signs may indicate that a metal-on-metal hip implant is failing. You should be aware of both local and systemic symptoms.

If you notice any unusual symptoms after getting a metal-on-metal hip implant, contact your surgeon right away. They may recommend blood tests to check metal levels or an MRI to see if there’s any damage or fluid buildup around the joint.

These symptoms could indicate a problem with the implant, but they might also have other causes. Regular check-ups with your health care provider are essential. They can help track how well the implant works and monitor your health.

What to Do if You’re Experiencing Hip Implant Complications

The Arthritis Foundation recommends that people with all-metal hip implants see their surgeons at least once a year. If you’re unsure about your implant type, ask your doctor.

It’s crucial to report any new symptoms, like difficulty walking, pain, swelling or numbness around the hip. The FDA advises patients to inform their doctors about any health changes, as tiny metal particles can impact the entire body.

Where to Find Trusted Legal and Medical Information on Biomet Hip Implant Safety

Here are four online resources for people with metal-on-metal hip implants:

These resources offer valuable information for individuals with metal-on-metal hip implants. They provide guidance on monitoring, potential risks and recommended follow-up care.

Editor Lindsay Donaldson contributed to this article.