Exactech Replacements: Hip, Knee, and Ankle

Exactech prosthetics are arthroplasty products, intended to offer a complete, complication-free replacement for hip, ankle, or knee joints.

When these products work well, patients may live for decades with few or no joint-related symptoms and without the need for additional procedures. When they are defective, they can cause complications or even total failure, requiring additional surgeries and causing distressing symptoms.

Exactech Polyethylene Liner Failures

Exactech’s recalled joint replacement systems typically rely on one of two types of liner: ultra-high molecular weight polyethylene (UHMWPE) and cross-linked polyethylene. Both types have become the subject of recalls.

The recalled Exactech products tend to show higher rates of necessary revision surgeries than other devices. For example, multiple studies show that Exactech Optetrak TKR systems had significantly higher revision rates than other devices. Many of these devices showed premature degradation of the polyethylene liners.¹

Exactech UHMWPE Knee and Ankle Replacement Systems

Ultra-high molecular weight polyethylene (UHMWPE) is an engineering polymer used in medical devices for its resistance to wear, ductility (ability to stretch or thin), and low rates of allergic or other bodily reactions.²

The use of UHMWPE on prosthetic surfaces has led to cases of wear and osteolysis (degradation of the bone at the prosthetic site) in hip, knee, and ankle replacement systems, however. Other products, including cross-linked polyethylene, have demonstrated less wear and fewer complications, even after years of use.³

Exactech’s Vantage Total Ankle System is its only ankle replacement product on the market. Unlike some other Exactech products including the Connexion GXL Liner, the Vantage Total Ankle System shows postoperative complication rates similar to or lower than other systems. Nonetheless, Exactech recently announced a recall of the Vantage Total Ankle System due to its non-conforming packaging.⁴

FDA Recalls for Exactech Connexion GXL Liner

The Connexion GXL liner was introduced in 2005. Its goal was to use cross-linked polyethylene, rather than UHMWPE, to reduce polyethylene wear in joint prosthetics.

The Connexion GXL Liner fell short, however. In a 2020 review, researchers at the University of Florida College of Medicine identified a high rate of short- to mid-term failures in the Connexion GXL Liner. The average time from implantation to diagnosis of implant failure was 55.9 months, with a range between 12 and 120 months.⁵

FDA Recalls for Exactech Knee and Ankle Components and Systems

The US Food and Drug Administration (FDA) has issued several recalls for various Exactech knee, hip, and ankle components and systems. These include:

• September 9, 2022: Four recalls focused on the GXL Neutral Liner and the Novation GXL Lipped Liner⁶
• August 30, 2021: Several recalls focused on various OPTETRAK knee and hip system components which were improperly packaged, as well as for the Vantage Total Ankle System
• July 22, 2021: A batch of recalls focused on the Exactech Connexion GXL Acetabular Polyethylene Liners in various joint replacement systems⁷

On June 28, 2021, Exactech also issued an official recall for certain Connexion GXL liners.⁸ This was followed by a similar recall notice in August 2022, focusing on seven Exactech products with clearance dates from October 1993 to July 2007:⁹

• Acumatch GXL
• MCS GXL
• Novation GXL
• Exactech All Polyethylene Cemented Cup
• Acumatch Conventional UHMWPE
• MCS Conventional UHMWPE
• NOVATION Conventional UHMWPE

Premature wear rates in Exactech Connexion GXL and UHMWPE liners are high enough that the devices have become subject to recalls and investigation by the US Food and Drug Administration.

According to the FDA, failure of the recalled Exactech devices may present as:

• New or worsening pain at the implant site
• New evidence of bone loss or accelerating bone loss
• Swelling in the affected area
• Early and excessive device wear
• Broken device components
• Device failure¹

The FDA does not recommend revision surgery for patients who have no pain or symptoms and whose implants are working as intended.

Historically, total hip arthroplasty patients tend to do well post-surgery. A February 2019 meta-analysis of 215,000 total hip replacement patients found an overall 58 percent survival rate for the implants 25 years after surgery.¹¹ The top two incidents requiring revision surgery across all prosthetic hip implant types are mechanical loosening and implant instability, respectively.¹²

The Exactech Connexion GXL Liner shows higher prevalence rates, however. In a 2020 review, researchers at the University of Florida College of Medicine identified a high rate of short- to mid-term failures in the Connexion GXL Liner. The average time from implantation to diagnosis of implant failure was 55.9 months, with a range between 12 and 120 months.³

Diagnosis of a total joint replacement failure may include the use of a physical examination and imaging testing, including X-rays or SPECT/CT scans. A technetium-99 bone scan and labeled leukocyte scan may also aid diagnosis, but both tests may yield false positives when performed within a year of the initial joint replacement. Negative scans can help exclude the possibility of infection, however.¹³

Potential contributors to failure in Exactech Connexion GXL polyethylene liners include:⁵

• Improper acetabular component positioning
• Increased polyethylene wear due to edge loading caused by improper positioning

Due to the high rates of osteolysis associated with the Connexion GXL, researchers believe the issue is with the polyethylene liner rather than the acetabular socket.⁵

For patients, risk factors associated with the need for joint replacement revision surgeries include younger age, being male, and experienced avascular necrosis. ¹⁴

The FDA recommends that providers do not implant any device that has been recalled by Exactech. The FDA also recommends monitoring patients who have recalled devices, even if the patients do not currently show symptoms of joint replacement system failure.¹⁰

The lasting effects of total joint replacement system failure may include:

• Permanent bone loss
• Damage to surrounding tissues
• Chronic pain

The full range of lasting effects is not yet known, as research into the long-term impacts of total joint replacement system failure is still underway.

The FDA’s treatment recommendations for healthcare providers include:

• No longer implanting any device subject to recall and returning any recalled devices to Exactech.
• Monitoring patients with “any implanted devices manufactured by Exactech between 2004 and August 2021” for signs of device wear, device failure, or bone loss.
• Consider ordering X-rays for patients where device failure or bone loss is suspected.
• Discuss revision surgery with patients with worsening pain or joint weakness that may be related to device failure. This step should be taken on a case-by-case basis, and all risks and alternatives to surgery should be discussed with the patient.¹⁰

Exactech claims that inadequate or non-conforming packaging may be to blame for the premature degradation of the polyethylene liners. The company alleges that improper packaging leads to increased oxidation in the system, which “can severely degrade the mechanical properties of conventional UHMWPE.”⁴

Complications from total joint replacement system failure may include:

• New or worsening pain at the replacement site
• Swelling, redness, or tenderness at the replacement site,
• Decreased range of motion in the affected joint
• Instability of the affected joint
• Bone loss where the joint replacement system connects to surrounding bone

Complications of revision surgery to correct a failed joint replacement system include:

• Wound infections
• Infection around the joint replacement system
• Blood clots
• Nerve injuries¹⁵

Strength of available evidence: Moderate to high

• A considerable number of reports and investigations level by providers and international registries are available, suggesting an important level of credibility.

In September 2022, 54 lawsuits related to the Exactech implant recall were filed in Florida state court, where they were later consolidated.

A multidistrict litigation (MDL) case, MDL 3044, was approved in October 2022 and centralized in the Eastern District of New York under Judge Nicholas G. Garaufis. At the time, 75 Exactech recall lawsuits were pending in various federal courts.

By December 2022, Exactech MDL 3044 included 111 lawsuits.¹⁶