Zimmer Hip Replacements: Failures, Recalls & Safety Concerns

Zimmer’s metal-on-metal (MoM) design caused unforeseen problems with its hip implants, including a condition called metallosis. These issues led to device failures and health complications.

Metal-on-metal implants were initially believed to last longer than other types of hip implants and were marketed as such. However, many failed earlier than expected. Two Zimmer metal-on-metal hip implants resulted in more than 1,000 lawsuits against the company for early failures and hip replacement complications.

The CPT Hip System, which doesn’t feature a MoM design, was also recalled in 2024 for risk of thigh bone fracture.

Metal-on-metal hip implants can release tiny metal particles into the body, which may lead to a condition called metallosis. This can result in serious health issues like heart problems and nerve damage, along with weakened bones and loosened implants. Often, surgery is needed to address these complications.

Metallosis & Systemic Health Risks

Metal-on-metal hip implants can create tiny metal particles from rubbing against each other. When these metal parts grind together, they can release high amounts of metal ions into the blood, surrounding bone and other tissues. This, in turn, can lead to a condition known as metallosis, a type of metal poisoning in the body. It can result in joint loosening, fractures and other health complications.

Studies are mixed on the increased risk of cancer as a result of MoM implants. These health issues may appear years after receiving the implant.

Metallosis and early failures led to Zimmer MoM hip recalls and two multidistrict litigations (MDLs) against the company. An MDL allows several similar Zimmer hip replacement lawsuits to be combined in a single litigation in one court to speed the legal process.

Metallosis Can Cause Implant Loosening, Dislocation & Fractures

The metal ions released by MoM joints can cause inflammation and bone destruction around the implant, which is known as osteolysis. If the bone weakens too much, the implant may become loose, resulting in pain and trouble walking.

As the bone deteriorates, the risk of fractures increases, especially if the implant is loose and not properly supporting weight. Many of these problems can go unnoticed until serious harm has been done.

The tiny metal particles can also hurt soft tissues around the joint, sometimes forming lumps called pseudotumors. While these lumps are often asymptomatic, they can cause inflammation, pain, clicking sounds or dislocation.

Current recommendations for unsuccessful implants typically involve a revision surgery to remove and replace the MoM implant if it’s causing problems. Another possible option may be chelation therapy, which treats heavy metal poisoning by removing harmful metals from the body. But that may require more research.

By 2013, an estimated 500,000 Americans were living with a metal-on-metal implant of some kind. It would be another three years until new FDA regulations forced manufacturers to stop marketing their devices.

The FDA faced a raft of metal-on-metal hip replacement recalls by several manufacturers between the early 2000s and 2016. Among those was Zimmer, which recalled three hip devices between 2008 and 2022. Two of them were metal-on-metal hips.

Zimmer Durom Cup Recall

Zimmer recalled the Durom Cup on July 22, 2008. That same day, the company told surgeons to stop using these devices until they received proper training. As a precaution, the company paused all marketing and distribution in the U.S. until the training and updated surgical instructions were completed.

The FDA classified it as a Class II recall. A Class II recall occurs when a product may cause temporary health issues, but serious harm is unlikely.

Zimmer M/L Taper With Kinectiv Technology Recall

On May 18, 2015, Zimmer recalled its M/L Taper with Kinectiv Technology, affecting 64 lots and 752 implants. This action was due to higher-than-expected manufacturing residues, which could lead to allergic reactions, pain or infections, any of which could potentially require surgery. The issues with the implant could result in death.

The FDA labeled this device’s recall as Class I, the agency’s most serious type of recall. Class I recalls occur when a product could seriously harm people’s health or even lead to death, making it crucial to stop using it right away.

Zimmer Biomet’s CPT Hip System Femoral Stem Recall

On July 2, 2024, Zimmer Biomet announced a recall to update instructions for their CPT Hip System due to an increased risk of thigh bone fractures.

Zimmer Biomet announced it planned to stop selling the device by December 2024. While the FDA is concerned about its continued use in new patients, the agency does not recommend removing a well-functioning system.

Data from the UK indicates that about 1.4% of patients with CPT Hip Systems experience device-related fractures. Similar hip replacement devices have lower fracture rates, ranging from 0.6% to 1%.

In 2016, the FDA established new rules to protect patients from the risks of metal-on-metal hip implants. These rules required companies to stop selling existing MoM hips and submit to stricter approval rules.

No metal-on-metal total hip replacements are currently approved for use in the U.S. However, there are metal-on-metal hip resurfacing devices that have met the FDA’s safety standards and remain available.

Over a thousand Zimmer hip lawsuits on the two recalled devices resulted in two separate MDLs. Common complaints were injuries or health complications related to metallosis or implant failures.

Zimmer Durom Cup Litigation

The U.S. Judicial Panel on Multidistrict Litigation (JPML) combined 45 Zimmer Durom Cup lawsuits into an MDL in 2010. The lawsuits claimed the devices were defectively designed and manufactured. They also alleged Zimmer failed to provide adequate warnings concerning the device’s safety.

Zimmer settled the MDL, and it was closed in 2020. The Zimmer Durom Cup settlement offered compensation to eligible claimants through two programs.

Base Award Program

• This program provided $175,000 per claimant, with possible reductions based on implant duration, age or prior revisions. Enhancements were available for severe complications or additional surgeries.

Fixed Award Program

• This program gave $25,000 per revision for cases involving early failure, unrelated deaths, or legal limitations. Some claimants could also seek extra compensation for extraordinary injuries or financial losses.

Zimmer M/L Taper Hip Litigation

In 2018, seven Zimmer M/L Taper Hip lawsuits were consolidated into MDL-2859, growing to over 300 cases. Plaintiffs alleged that the devices were unsafe, causing metal wear and damage that required further surgeries, and claimed Zimmer failed in design, testing and risk warnings.

Zimmer Biomet’s 2023 Annual report indicated it had set aside $146.2 million for litigation and product liability, but did not specify how much was earmarked for resolving the few remaining cases in the MDL.

If you have a Zimmer MoM or CPT Hip System implant, be vigilant about monitoring your health and the implant. The FDA recommends against surgery if your implant is operating effectively and you are pain-free. However, if you experience any new or increasing pain, swelling, weakness, or strange sounds, reach out to your doctor immediately.

If your implant is not causing problems, no action is needed beyond regular monitoring. Always follow up with your doctor if you have concerns about your joint replacement. They can determine whether you need additional monitoring, tests or revision surgery.

Where to Find More Information

There are several online resources for people who may have a Zimmer MoM implant.