Smith & Nephew Hip Replacements: Failures, Recalls & Safety Concerns

Smith & Nephew’s metal-on-metal (MoM) hip implants, like the Birmingham Hip Resurfacing and R3 Acetabular System, had serious safety issues due to design flaws.

Over time, they would wear down, potentially releasing harmful metal particles that may cause tissue damage and implant failure. The company recalled some models but faced over 1,000 lawsuits from injured patients.

The Problem With Smith & Nephew Metal-on-Metal Hip Implants

Smith & Nephew’s MoM hip implants contained metal components, usually a ball and socket, that could rub together and wear down. This friction can release harmful metal ions into the bloodstream.

Metal ions released from metal parts rubbing together can destroy bone and soft tissue near the implant and could travel through the bloodstream.

These metal ions sometimes cause metallosis, a form of metal poisoning resulting in inflammation, tissue damage and loose implants. Consequently, many patients needed early replacement surgeries.

After high failure rates were discovered, Smith & Nephew issued recalls and faced lawsuits from patients who claimed the company knew about the risks yet continued to market the implants as safe.

Smith & Nephew faced legal issues due to problems with its MoM hip implants, which have high failure rates and serious complications. In 2016, the FDA made regulations stricter, hindering the sale of new MoM implants. 

The company recalled several devices over safety concerns and has been involved in hundreds of lawsuits. While most were settled or dismissed, some are still ongoing.

What Has the FDA Done About Smith & Nephew Hip Implant Failures?

The FDA warned Smith & Nephew about quality control issues at their hip implant factory in Tuttlingen, Germany, in December 2010. This warning highlighted failures in testing and correcting problems with their R3 Acetabular System ceramic implants. 

In 2016, the U.S. Food and Drug Administration (FDA) made it harder to sell MoM hip implants by requiring manufacturers to get premarket approval. Approval is based on scientific evidence that the device is effective and safe.

New U.S. Food and Drug Administration regulations made it nearly impossible for medical device manufacturers to design, develop or market MoM hips after February 2016. This effectively eliminated MoM hips in the United States.

Smith & Nephew Hip Implant Recalls & Safety Warnings

Smith & Nephew recalled several hip devices between 2012 and 2016 due to high failure rates and reported complications like pain and metallosis.

Lawsuits & Settlements Related to Smith & Nephew Hip Implant Failures

Previously, there were almost 1,100 Smith & Nephew BHR lawsuits in a federal multidistrict litigation (MDL). MDLs allow several similar lawsuits to be combined in a single litigation to make the legal process more efficient.

Some Smith & Nephew hip lawsuit claims were dismissed as preempted, but the court allowed discovery on failure to warn, negligence, breach of express warranty and negligent misrepresentation.

In July 2023, Smith & Nephew asked the court to dismiss all lawsuits against the company, but the court refused. Earlier annual reports indicated that there had been “several group, as well as individual, MoM-related settlements without admitting liability.”

As of early 2025, only two cases remain in the MDL, which may indicate that the lawsuits were settled. The Smith & Nephew 2024 Annual Report indicated that about 300 claims against the BHR system are still pending worldwide.

Smith & Nephew’s BHR system was one of the first MoM hip implants, introduced in 1997. As a pioneer of MoM technology, the company played a significant role in the hip implant controversy of the 2010s.

Initially marketed as a strong and long-lasting option for active individuals, MoM hips were later found to have higher failure rates and serious health concerns, like metal poisoning. Several major manufacturers have faced thousands of combined lawsuits over injuries caused by these devices.

In comparison, DePuy Orthopaedics completely withdrew its Pinnacle implant in 2013 due to similar problems, while Biomet faced lawsuits concerning its M2A Magnum implant but did not recall it.

Smith & Nephew’s response has been less comprehensive, yet its legal challenges are significant.

The failures of Smith & Nephew’s BHR system and other MoM implants have significantly impacted the industry. There are now stricter regulations, improved testing and new technologies to increase safety and implant longevity.

These efforts aim to improve implant safety while advancing surgical techniques, making hip replacements more reliable for patients.

Recognizing failure symptoms early is crucial if you have a Smith & Nephew or any MoM hip implant. Regular follow-ups with your orthopedic surgeon can help monitor your implant’s condition and identify potential concerns.

Recognizing Implant Failure & Associated Health Risks

If you have a MoM hip implant, it’s important to follow up with your orthopedic surgeon as recommended. They may suggest more frequent visits depending on your implant type and recovery.

At each appointment, discuss any new or worsening symptoms, like pain, swelling or changes in your ability to walk. Also, update your surgeon on any changes in your overall health.

These symptoms might be local, affecting the hip area, but there could also be systemic symptoms involving your skin, kidney, heart, thyroid or nervous system. Metal particles from the implant may cause tissue damage around the joint, leading to loosening and potential implant failure.

In some cases, metal ions enter the bloodstream, causing reactions like:

It’s important to consult your doctor if you experience any of these symptoms.

Resources for People With a Smith & Nephew Hip Implant

If you had hip replacement surgery before May 18, 2016, you might have a MoM implant, which can pose risks over time. The FDA suggests consulting your doctor for information on your implant type and safety concerns.