Every year in the United States, physicians perform more than a million arthroplasties, including more than a million knee replacements and 300,000 hip replacements. This number is expected to increase to four million by 2030, according to Orlando Health.
Joint arthroplasty is regarded as one of the most successful procedures in modern medicine, providing patients with years and even decades of independence and freedom from pain. Unfortunately, negligent manufacturer Exactech produces products that harm patients rather than help them.
The O’Mara Law Group helps people who have been injured by large companies through no fault of their own.
What is the issue with Exactech joint replacement products?
Joint replacements include components made of polyethylene, a special type of plastic that interacts with the metal components so they do not rub together when the joint moves, according to the American Academy of Orthopaedic Surgeons.
This increases the longevity of the joint replacement and protects the patient from the danger of metal shavings entering the surrounding tissues.
The polyethylene insert is designed to resist wear, resulting in a joint replacement product that can last for a significant period of time, according to the Hospital for Special Surgery (HSS) in New York:
The polyethylene components of Exactech’s ankle, knee, and hip replacements have exhibited a pattern of wearing prematurely, sometimes in as few as five years.
Knee and Ankle Implants
The FDA reported that Exactech has recalled several knee and ankle replacements due to faulty packaging that has allowed oxygen permeation into the product, precipitating the product’s propensity to wear prematurely. The recall was initially announced on August 31, 2021, and impacted products that were sold to the public beginning as far back as 2004.
The product specifications require it to be packaged in oxygen-resistant vacuum bags. While Exactech did use vacuum bags, the manufacturer failed to include a secondary barrier layer that contained ethylene vinyl alcohol, which would have improved the oxygen resistance of the bag through the extra layer of protection.
The result was oxidation of the product, which caused it to break down sooner. When a patient’s implant wears prematurely, debris from the degradation process is released into surrounding tissues, resulting in adverse reactions.
According to the Australian Orthopaedic Association National Joint Replacement Registry, the studied models of Exactech’s knee replacements needed revision surgeries at over six times the rate of all other knee replacements (20 percent compared to 3.3 percent after five years).
According to Exactech’s website, the GXL acetabular liner surrounding several models of Exactech hip replacement products has shown premature wear, especially in the thinnest models and in patients with higher risk factors, such as obesity or a more active lifestyle. The wear occurs when edge loading is present.
This was confirmed in a study published in Arthroplasty Today of 204 patients who had received the Exactech Connexion GXL Liner. Five patients experienced severe polyethylene wear within five years, resulting in adverse effects.
The Consequences of Premature Wear
The accelerated wear that occurs during oxidation leads to excessive debris entering the surrounding tissues, resulting in the component cracking and osteolysis in the patient.
What is osteolysis?
Osteolysis is an inflammatory response to the influx of particles from worn joint replacement components. The condition causes the loss of bone tissue. It is typically asymptomatic, which means the patient could experience significant bone loss before the condition is detected. Bone loss precipitates failure of the implant and creates the need for revision surgery.
What products are included in the Exactech recall?
Exactech announced a recall of several models of the following knee and ankle replacements containing the polyethylene inserts:
On April 7, 2022, Exactech added the following knee and ankle replacements containing ultra-high molecular weight polyethylene (UHMWPE) to the recall:
Hip Replacement Liners
Rather than recalling the faulty hip replacement liners, Exactech recommends that patients in need of a revision upgrade to Exatech’s new model, which uses Exactech’s latest generation HXLPE and Vitamin E-infused liner. This raises questions about how long Exactech was aware of the issue.
Rather than recall the product, the company designed and manufactured a new model, a demonstration that profit is prioritized over safety. Designing a new model does not absolve Exactech of its responsibility to offer a safe and effective first-generation product.
What is revision surgery?
Revision surgery occurs when the initial joint replacement needs to be repaired or replaced. Revision surgery is more complex than an initial joint replacement surgery with a higher risk of complications. These surgeries require greater skill and preoperative planning.
Possible complications include:
In revision surgery, the surgeon must remove the original implant, which may have fused to the existing bone. This can result in significant bone loss, which may require a bone graft to ensure that enough bone is in place to support the new joint replacement and encourage new bone growth.
Revision surgeries do not have the same longevity as initial joint replacements. For example, knee implants received during a revision surgery generally have an expected life of 10 years as opposed to 20 years for initial arthroplasties.
What should I do if I have a recalled knee replacement that has not failed yet?
You may be unaware of the brand and model number of your knee replacement, but you should be able to get this information from your surgeon. If you learn that your joint replacement is one of the recalled products, your physician can advise you on the best course of action. Having an affected product does not necessarily mean your implant will fail prematurely.
Exactech is advising physicians against preemptive revision surgeries. Instead, the company has recommended physicians monitor the implant and surrounding area for signs of osteolysis, wear, and failure. Since osteolysis tends to be asymptomatic, you may need regular imaging studies.
Taking Legal Action vs. Filing a Patient Reimbursement Claim with Exactech
Failed knee replacements resulting in revision surgeries cause significant pain and suffering and can result in long-term health effects, especially in patients whose health status does not permit them to undergo revision surgery. Patients should not have to pay for the mistakes of negligent manufacturers.
Exactech owed consumers a duty of care, which it violated when it began selling products in defective packaging in 2004 but failed to recall the products until 2021. This amounts to 17 years of negligence at a severe cost to patients. If your Exactech joint replacement has failed, you are entitled to file a civil lawsuit and receive fair and just compensation for your injuries.
Exactech is offering to reimburse patients for some expenses through the Broadspire — an insurance company that represents and works in the best interests of Exactech.
Before considering any offer from Exactech or Broadspire, contact a personal injury lawyer who will work in your best interest and fight to obtain your rightful compensation.
How much compensation can I recover in an Exactech knee replacement lawsuit?
Every case is unique, and it is impossible to estimate the amount of compensation you can recover without knowing the specifics of your case. The following compensation may be available:
How much time do I have to file an Exactech recall lawsuit?
Every state has a statute of limitations, which generally ranges from one to three years from the date of injury or the date of discovery. Many exceptions to these statutes exist, especially in mass tort cases, and you may also have a choice of which jurisdiction in which to try your case.
Consult with your attorney as soon as possible to ensure timely filing of your case.
Is there a class-action lawsuit against Exactech?
There are currently no class-action lawsuits against Exactech. A large number of civil claims against Exactech is expected, and the cases may be consolidated into multidistrict litigation (MDL), the transfer of multiple cases to a single federal court to be heard by one judge.
O’Mara Law Group Is Accepting Exactech Knee Implant Cases
O’Mara Law Group is committed to helping good people through difficult situations. Exactech is a large company with the financial resources to hire expensive counsel that will try every trick in the book to avoid paying its victims the compensation they rightfully deserve.
Mark O’Mara has this to say about large drug companies: “I know that I can go toe-to-toe with any drug company lawyer that they want to put in a courtroom against me. Because that’s what trial practice truly is. You have to be better than the other side. It is truly a war room, and I win in war rooms.”
Mark O’Mara is a legal analyst for CNN with over 40 years of experience practicing law. He is also a law professor and frequently offers consulting services to legal teams on difficult cases. His legal team offers personalized service.
The O’Mara Law Group is accepting cases nationwide. Time is limited. Contact us today to schedule a consultation.
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