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Exactech Knee and Ankle Implant Recall Attorneys

NOTICE: If you need to have, or have already had, revision surgery to replace a faulty Exactech implant, contact the attorneys at Console & Associates at (866) 778-5500 to discuss your legal options, or submit a confidential Case Evaluation form here.


Revision Surgeries and Bone Loss Related to Exactech Knee and Ankle Implants

Exactech knee and ankle implants are commonly used by healthcare providers to replace joints that suffered irreversible damage due to arthritis and other conditions. However, the company recently recalled more than 147,000 ankle and knee implants citing concerns over defective packaging. Based on Exactech’s own statements, patients who had defective devices implanted have a much higher chance of experiencing bone loss. The defective medical devices can also break down or even fracture while in a patient’s body—much earlier than the state lifespan of the product. In either case, affected patients may need to undergo an additional revision surgery to remove the defective knee or ankle implant, leading to a host of other potential complications.

The experienced personal injury lawyers at Console & Associates P.C. can help. Our product liability attorneys are actively investigating Exactech implant claims on behalf of individuals who suffered bone loss and those who needed revision surgeries after having a defective device implanted. We can help familiarize you with your rights and explain your options so you can make the best decision for you and your family.

For a free, confidential consultation, call (866) 778-5500 today.

Why Are Exactech Knee Implants Being Recalled?

Both knee implants and ankle implants manufactured by Exactech are being recalled for the same reason, which stems from the fact that the devices were packaged in out-of-specification vacuum bags.

Evidently, in August 2021, Exactech initiated the first round of recalls out of concerns that the vacuum bags used to package the devices allowed the devices to be exposed to oxygen. This can lead to a process called oxidation. According to Exactech, “The use of these non-conforming bags may enable increased oxygen diffusion … resulting in increased oxidation of the material relative to inserts packaged with the specified additional oxygen barrier layer. Over time, oxidation can severely degrade the mechanical properties of conventional [ultra-high molecular weight polyethylene insert], which … can lead to both accelerated wear debris production and bone loss, and/or component fatigue cracking/fracture, all leading to corrective revision surgery.”

The recall is classified as a “Class II recall,” which means that the use of the product “may cause temporary or medically reversible adverse health consequences.” However, this assumes that a patient’s health allows for the revision surgery. For those older patients or those experiencing other health conditions, additional surgery presents significant risks which may lead to permanent, irreversible injuries.

Which Exactech Devices Were Recalled?

Initially, Exactech determined that 80 percent of the devices contained inserts that were susceptible to oxidation. However, more recently, the company decided to recall all knee and ankle arthroplasty polyethylene inserts packaged in non-conforming bags regardless of label or shelf life. Based on Exactech’s records, “There are approximately a total of 143,484 inserts implanted in the US since 2004 that were produced with non-conforming packaging.” These include:

  • OPTETRAK® All-polyethylene Tibial Components (TKR)
  • OPTETRAK® All-polyethylene Tibial Components (PKR)
  • OPTETRAK® Tibial Inserts (TKR)
  • OPTETRAK® HI-FLEX® Polyethylene Tibial Inserts (TKR)
  • ARTHROFOCUS® Polyethylene Tibial Inserts (TKR)
  • OPTETRAK® Custom Polyethylene Tibial Inserts (TKR)
  • OPTETRAK® LOGIC® Polyethylene Tibial Inserts (TKR)
  • OPTETRAK® RBK® Polyethylene Tibial Inserts (TKR)
  • TRULIANT® Tibial Inserts (TKR)
  • OPTETRAK® Logic RBK Tibial Components (TKR)
  • Vantage® Fixed-Bearing Polyethylene Liner Component (TAR)
  • Vantage® Mobile-Bearing Polyethylene Liner Component (TAR)

What Are the Signs of a Defective Knee or Ankle Replacement?

Exactech is advising surgeons and other healthcare professionals to avoid implanting defective devices and keep an eye on the symptoms of those patients who already had the devices implanted. The following are signs that an Exactech knee or ankle implant is showing signs of premature wear-and-tear due to exposure to oxygen:

  • New or worsening pain,
  • An inability to bear weight,
  • Grinding or other unusual noises/sensations,
  • Swelling, and
  • Instability in the knee or ankle.

If you are experiencing any of the above symptoms of a defective knee implant, it is imperative that you reach out to your doctor to determine if your device was recalled. You should also consult with the experienced Exactech recall lawyers at Console & Associates, P.C. to learn more about your rights and legal options.

Is the Exactech Recall Serious?

Yes, based on Exactech’s own estimates, those patients who had a defective device implanted face a much higher risk of requiring a revision surgery. The company places this risk at three to seven times greater than patients who had compliant devices implanted.

Revision surgery raises all the risks of traditional surgery; however, it also presents additional risks because there may be scarring, which can make the surgery more difficult to perform and make it harder for patients to heal after the surgery.

These risks are especially high for patients who are older, have a compromised immune system, or have pre-existing health conditions.

Can Patients with a Defective Exactech Device Sue the Company?

“… if evidence emerges that a device manufacturer knew that their product was defective but continued to market and sell the product anyway, it opens the door to the possibility of punitive damages.”
Certainly, no one wants to go through the physical and mental stress of a surgery only to learn that the device they had implanted was defective and they may need an additional surgery. Even if the company were to cover the costs of implanting a new device, this doesn’t account for all the trouble patients are being put through. Thus, many patients are wondering if they can sue Exactech based on the company’s defective knee and ankle implants.

As a general matter, medical device manufacturers have a duty to consumers to ensure that their device is safe and works as advertised. If a device is defective, including devices contained in defective packaging, the company may be liable through a product liability lawsuit.

Product liability lawsuits are unique among personal injury claims because, in many cases, they do not require a patient to show that the manufacturer was negligent. Instead, patients can prove a product liability lawsuit by proving that the device was defective—either in its design, the way it was manufactured, or the warnings contained on the device.

However, if evidence emerges that a device manufacturer knew that their product was defective but continued to market and sell the product anyway, it opens the door to the possibility of punitive damages.

In either case, bringing an Exactech product liability lawsuit is important for several reasons. First, successfully pursuing a claim against the company will provide your family with the financial resources needed to obtain the necessary medical treatment, both now and in the future. It will also mean you are compensated for the pain and suffering—both mental and physical—you endured. Second, product liability claims are important tools because they hold manufacturers accountable for their actions. Medical device manufacturers, like all businesses, operated to generate a profit. Sometimes, this means cutting corners to save a few dollars per device. However, these shortcuts sometimes place patients’ lives in danger, and companies need to know that they cannot take liberties with patients’ health without fear of financial consequences.

Currently, the Exactech product liability lawsuits that have been filed are still pending. Thus, there have been no reported settlements or jury verdicts. However, given the fact that there are at least 147,000 people in the United States living with defective devices in their bodies, the number of Exactech recall lawsuits is expected to surge in the near future. Those interested in learning more about Exactech lawsuits should reach out to the dedicated injury lawyers at Console & Associates, P.C.

Schedule a Free Consultation with an Exactech Product Recall Lawyer Today

No Fee PromiseIf you recently learned that your Exactech ankle or knee implant was among the recalled devices, your health may be at risk. If you need a revision surgery, it will undoubtedly interrupt your life and expose you to the additional dangers of an otherwise unnecessary surgery. Of course, this comes as a surprise to you, who had no idea that the device doctors placed in your body was defective. At Console & Associates, P.C., we strongly believe that it shouldn’t be up to you and your family to face the economic and lifestyle costs associated with the recall and subsequent revision surgery you may need.

Through an individual or class action Exactech recall lawsuit, you may be able to obtain financial compensation for the harm you experienced as a result of the defective device. The experienced attorneys at Console & Associates, P.C. are currently seeking to interview potential claimants regarding legal actions stemming from the implantation of recalled Exactech devices. Taking part in a class action investigation or an Exactech lawsuit requires no upfront fees or payment.

At Console & Associates, P.C., our product liability attorneys have decades of experience holding medical device manufacturers and other organizations responsible for causing harm to people, and we welcome any questions you may have. You can learn more about the steps you should take and the legal options available to you during a free, no-obligation consultation.

Just call (866) 778-5500 or fill out our secure online contact form to speak to a knowledgeable legal professional today.

NOTICE: If you need to have, or have already had, revision surgery to replace a faulty Exactech implant, contact the attorneys at Console & Associates at (866) 778-5500 to discuss your legal options, or submit a confidential Case Evaluation form here.
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