Exactech Faces Product Liability Claims Concerning Knee Replacement Recall

Patients who undergo joint replacement surgery expect their new hardware to last for many years. Some patients even expect that their hardware will outlive them.

Dani Alexis Ryskamp, J.D.

Written by
— Updated on May 13, 2022

Exactech Faces Product Liability Claims Concerning Knee Replacement Recall

Patients who received one of about 140,000 Exactech knee or ankle replacements, however, are now facing a recall because their replacement joints may wear out sooner than expected.

Exactech’s Knee Replacement Implant Recall

Exactech first announced a recall in August 2021. At the time, the company noted that the recalled implants could fail prematurely. In addition, the knee replacements could crack or fracture, cause bone loss, or lead to other problems that might require patients to undergo additional surgery.

After “extensive testing,” Exactech expanded the original August 2021 recall. To date, the recall covers approximately 140,000 knee and ankle replacements manufactured since 2004. It includes versions of Exactech’s OPTETRAK partial and total knee replacement systems and OPTETRAK Logic total knee replacement systems. The recall also includes the TRULIANT total knee replacement systems. Additionally, the company recalled 1,561 units of Exactech’s VANTAGE Fixed-Bearing Linear Component total ankle replacement systems. Exactech introduced this product in the US in 2016.

Alleged Product Defects in Exactech Knee Replacements

In a letter intended for knee replacement patients, Exactech explains that the packaging for the knee replacements’ plastic inserts may have allowed oxygen to diffuse into the plastic insert. Inserts that came into contact with oxygen before implantation may oxidize. Oxidation “can cause the plastic to wear out earlier than expected or to become damaged after it is implanted into the patient’s body,” according to Exactech.

The letter asks patients to return to their treating provider for evaluation. At that time, each patient and their provider can determine the appropriate next steps based on the condition of that patient’s implant, the implantation site, and overall health.

Patients may also experience symptoms in the affected joint that include:

  • New or worsening pain
  • Problems with weight-bearing
  • Sounds such as grinding or clicking noises
  • Swelling
  • Joint instability

Ankle replacement systems are expected to last 10 to 20 years with normal use. After this, patients may need revision surgery. Oxidation in the Exactech systems, however, may lead to a need for revision surgery in as little as five years. Some patients may require revision even before the five-year mark.

Although Exactech announced the recall in 2021, evidence of problems with its products was mounting before that date. A 2012 study in the journal Orthopaedics & Traumatology: Surgery & Research found that the OPTETRAK cemented posterior stabilized knee prosthesis performed poorly approximately 2 years after implantation, despite expectations that its design would lead to better performance when compared to earlier models.

In October 2017, a plaintiff in the Northern District of Alabama filed a complaint against Exactech. The plaintiff alleged that the patient’s receipt of an OPTETRAK knee implant resulted in injuries. Additionally, the plaintiff claimed that there was a need for early revision surgery. The complaint also alleged that “By at least April 2008, Defendants became aware of a high rate of early failures with the ‘finned’ Optetrak products,” requiring additional revision surgeries.

Plaintiffs continue to file claims post-recall. In March 2022, a plaintiff in the Southern District of New York filed a complaint against Exactech. The plaintiff alleged that the OPTETRAK Logic total knee replacement systems the plaintiff received in 2013 and 2015 were defective. The patient suffered “pain, swelling, instability, and bone loss in both knees caused by early and accelerated polyethylene wear and component loosening.” Eventually, the patient had “extensive revision surgery” on both the right and left knee.

A class action lawsuit has not yet been organized for plaintiffs alleging injuries from the recalled knee or ankle implants. The filed claims are still in the early stages. However, a class action is one possible course the litigation may take.

Other Exactech Recalls

The knee and ankle replacement recalls and related lawsuits are not the first Exactech has faced. In July 2021, Exactech also announced a recall of its Connexion GXL acetabular polyethylene hip implant liner. The company cited a “risk of edge-loading and premature prosthesis wear” in relation to this recall.

As with the knee and ankle replacements, evidence existed prior to the recall that a problem was brewing. A June 2020 study in Arthroplasty Today examined 204 primary total hip arthroplasty procedures. The study found “5 cases of severe polyethylene wear and osteolysis which occurred within 5 years of the index surgery.” The researchers not only noted these numbers were a “concerning trend” but also stated that “further investigation is warranted to evaluate material characteristics which may have caused this accelerated wear and to prevent recurrences of this complication in the future.” A September 2020 letter to the editor in The Journal of Arthroplasty raised similar concerns.

In April 2022, a lawsuit focused on the recalled hip implants was set for trial. Like the knee and ankle implants, no class action focused on the hip implants has yet been created. Nonetheless, the pattern of medical evidence preceding the recall notice in both instances raises questions for Exactech, attorneys, and patients.

What to Expect from the Exactech Knee Replacement Recall

As information spreads about the knee replacement recall and patients return to their providers for evaluation, it is likely that more instances of premature wear, related symptoms, and the need for revision surgeries will come up. Pressure to form a class of those injured by the knee and ankle replacement systems will mount as more injury cases surface.

As with many medical device product liability claims, attorneys will likely call upon experts in several areas. One is to discuss the manufacture, design, and distribution of the medical device itself—here, the knee and ankle replacement systems. Another is to explore the effects of premature wear on the body, including the link between the wear and the patients’ reported symptoms.

Because medical device cases can be complex, clarity is vital. Consultations with qualified physicians through Case Clinics can help attorneys gain this clarity and explore essential issues. An on-demand consultation can provide benefits at any stage in one’s case.

Looking to consult a physician about your current case?

Work with our team of physicians to decide if your knee replacement case is meritorious.

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