Exactech Connexion GXL Hip Liners: Failure Risks, Recalls & Legal Concerns

Exactech’s hip liners were supposed to last for years, but internal tests and surgeon complaints showed the liners were wearing out too quickly. Yet the company kept selling them. As failures increased, patients suffered bone damage and needed more surgeries.

In 2021, Exactech recalled some hip liners used in their Novation, Acumatch, and MCS hip replacement devices due to excessive wear. The company said the cause was unknown. In 2022, Exactech expanded the recall to include all hip devices with plastic parts packaged in faulty bags that let air in, which caused these parts to fail sooner than expected.

The recalls affected over 40,000 hip liners used in seven Exactech hip replacement products. Eventually, the FDA stepped in, uncovering serious safety and quality issues.

Premature Wear & Implant Failure

Improper packaging for the Exactech Connexion GXL hip liners led to wear and tear of the materials used in the implants. This made the Exactech devices less stable, leading to joint issues.

As a result, many patients experienced significant pain and needed additional surgeries much earlier than they should have.

Symptoms of the implant failing include pain and mobility issues. Patients reported the joint catching and trouble walking — often within just a few years of surgery.

Many patients needed revision surgery within five years, despite modern polyethylene liners being designed for long-term durability. This raised serious concerns about the reliability of these implants, leading to recalls and lawsuits.

All Exactech joint replacement devices have a plastic part that needs to be stored in special packaging to keep out oxygen. However, some of these devices containing the GXL hip liners were packed in faulty bags that didn’t include a vital layer meant to protect them from oxidation.

Bone & Joint Damage From Polyethylene Wear

Wear-related osteolysis, which occurs when artificial hip liners like the Exactech Connexion GXL wear down, complicates revision surgery for failed hip replacements. This bone damage weakens the structure, making it difficult for surgeons to attach new implants securely.

In severe cases, they may need bone grafts, special cages for support, or cement to stabilize the new components.

The weakened bone also increases surgical risks, such as fractures during the removal of old parts and potential damage to the remaining bone during cleanup.

Chronic Inflammation Leads to Repeat Surgeries

When hip liners wear down, they release tiny particles into surrounding tissues. The body sees these as foreign and triggers a chronic inflammatory response, leading to pain and implant instability.

Over time, this process can lead to severe bone loss and ongoing discomfort, often requiring revision surgery to replace the failing implant.

Exactech faced regulatory and legal challenges after issuing multiple recalls starting in 2021. It also came under an FDA investigation, leading to a warning letter in early 2024 over delayed recalls and internal safety failures related to its hip implants.

Despite internal warnings and surgeon complaints, Exactech continued marketing its Connexion GXL hip liners, leading to patient injuries and an influx of lawsuits.

FDA Cites Internal Warnings and Delayed Recalls

According to statements from the U.S. Food and Drug Administration, Exactech’s internal testing and surgeon complaints revealed excessive wear in its hip components long before the official recall.

Despite these warnings and growing regulatory pressure, the company continued marketing the liners as long-lasting. Reports of implant failures and bone damage increased, prompting studies in medical journals.

Exactech received an FDA Warning Letter in early 2024 following an agency investigation. An FDA Warning Letter tells a company it has broken important safety or quality rules. It explains the problems and asks for fixes. The company must respond, and the FDA does a quality check to make sure improvements were made.

FDA Regulatory Response

The FDA categorized both Exactech recalls as Class II recalls — a situation where use or exposure to a violative product may cause temporary or reversible health issues, with a remote chance of serious consequences.

The agency advised healthcare providers to stop using these devices and to monitor patients for any issues. The FDA also continues to collaborate with global health authorities to review safety information and promises to keep the public updated as new details become available.

Exactech Patients File Hip Lawsuits

The recalls and injuries spurred a wave of Exactech hip lawsuits. A federal panel combined 27 lawsuits into a multidistrict litigation (MDL) in a New York federal court in October 2022. MDLs allow courts to try several similar lawsuits in a single litigation to expedite the legal process. There are currently 1,842 cases in the Exactech MDL.

Lawsuit complaints indicate that Exactech became aware of issues with Connexion GXL hip liners before September 26, 2013. Reports included unusual wear and early implant failures, leading to studies in medical journals addressing concerns like bone damage and early breakdowns.

According to one of the earliest complaints, by June 29, 2021, Exactech recognized an unexpectedly high failure rate of their hip liners. In response, the company began developing a new type of lining to address the issue.

Plaintiffs argue that Exactech, despite claiming their products were built to last, delayed warning the public about dangers and continued marketing the implants, potentially putting more patients at risk before issuing recalls.

Exactech filed for Chapter 11 bankruptcy protection in October 2024, struggling under the weight of over 2,600 lawsuits from patients who alleged its orthopedic devices were defective.

After the company recalled several of its joint replacement devices, Exactech faced mounting litigation costs and financial instability, which reached an estimated $20 million by late 2024. In response, the company secured $85 million in funding and agreed to sell its assets to investors.

The bankruptcy filing allowed Exactech to continue operating during restructuring but halted ongoing lawsuits. Plaintiff’s attorneys harshly criticized the bankruptcy filing just weeks before the first trial, calling it a “slap in the face” to people that Exactech implants injured.

If you have an Exactech hip implant, monitor it and your health closely. The FDA advises against surgery if your implant is functioning well without pain. However, if you notice new or worsening pain, swelling, weakness or unusual noises, contact your doctor right away. Knowing about your implant and your options can help you make informed health decisions.

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 an Exactech implant. In addition to the Connexion GLS hip liner, the packaging issue affected several other Exachtech joint replacements, including those for knee and ankles and multiple models of the company’s other hip implant products.