Exactech Hip Replacement Recall – Hip Recall Lawsuit
EXACTECH ISSUES URGENT HIP REPLACEMENT RECALLS FOR CONNEXION GXL HIP LINER
Exactech recalls the Connexion GXL hip replacement liners. Exactech notified the FDA that the plastic in the acetabular liners is wearing out faster than expected. The Food and Drug Administration (FDA) has listed these recalls as a class 2 device recall for Exactech Connexion GXL hip implant liners in July 2021. The FDA recall reports there are 89,050 of these hip replacement parts in circulation and may be implanted in people’s bodies. The specific Connexion GXL polyethylene liners recalled are used in the following hip replacement systems:
- Acumatch GXL
- Novation GXL
- MCS Hip System
EXACTECH SENDS WARNING LETTER TO SURGEONS
On June 24, 2021, Exactech provided doctors with a “Frequently Asked Questions” document indicating that Exactech was aware of a “higher risk of premature wear” with GXL liners. However, Exactech told doctors that it was “not recalling the GXL liner” because they claimed it “is considered safe and effective and performs as intended.” But five days later, on June 29, 2021, Exactech did trigger a recall of the GXL liner. This recall was done by sending an “urgent medical device correction” letter to Exactech agents, representatives, and distributors. The company also sent letters to surgeons recommending that patients follow up with their doctors if they got the hip implant in the last 6 years but have not had an appointment in the past 12 months. Exactech leaves it up to the surgeons to contact patients directly. Click on the image below to read Exactech’s entire letter to surgeons.
WHAT SHOULD I DO IF I HAVE AN EXACTECH GXL HIP IMPLANT?
Exactech recommends patients who were implanted with a GXL Polyethylene Acetabular Liner in the past 6 years and haven’t seen their surgeon in at least a year, should see their doctor now. Even if you’re not experiencing symptoms, it is important to have routine exams done to monitor your situation.
Every patient’s situation is unique and has its own complexities; our attorneys handle each client’s case with the care and respect they deserve. There is a limited amount of time to file a lawsuit for injuries suffered from a defective hip replacement. Don’t wait or you may run out of time to file a claim.
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WARNING ABOUT GIVING YOUR INFORMATION TO EXACTECH
Exactech may tell you that they will cover your out-of-pocket medical costs. Be careful before signing or agreeing to any type of compensation from EXACTECH. You may be signing away your rights. Contact the attorneys at mctlaw before contacting the EXACTECH-BROADSPIRE Helpline. Looking up your hip replacement serial number on the EXACTECH recall website may impact your rights. Contact an attorney first.
EXACTECH’S GXL HIP REPLACEMENT PROBLEMS
Exactech’s GXL Polyethylene Acetabular Liner is failing at a high rate and much earlier than the product’s intended lifespan. Exactech is a Florida-based medical device manufacturer that sells its orthopedic products nationwide. The model that Exactech made, the GXL Polyethylene Acetabular Liner, is part of a metal-on-polyethylene (MOP), or metal-on-plastic, hip implant.
According to research published in the May 2020 issue of The Journal of Arthroplasty, “historically, there has been excellent survivorship of total hip arthroplasty with newer implants expected to outperform prior generations” but “the Exactech Connexion GXL liner may be prone to a high rate of early failure from wear and severe secondary osteolysis. We recommend close surveillance of patients with this bearing surface.”
Most metal-on-plastic hip replacements are the gold standard and can last 25+ years without issues. The plastic material has continually improved over decades of use, leading to less wear over time and longer-lasting replacements. Yet there seems to be a design flaw in Exactech’s hip implant that differs from others of its kind.
Exactech marketed their hip replacement as more resistant to wear and fracture, yet Exactech’s product is failing early and at a high rate, leading to serious health risks and potentially complex revision surgery. mctlaw attorneys are investigating why the plastic material known to work well and considered a great medical advancement by many orthopedic surgeons is suddenly causing failure early and often in Exactech’s plastic hip liners. Our attorneys are filing lawsuits against Exactech across the country. Click Here to view the Exactech Complaint.
THE DIFFERENCE IN EXACTECH’S PLASTIC HIP IMPLANTS
THE PLASTIC USED IN ACETABULAR LINERS
Materials used in hip replacements took leaps in technology since the 1990s and 2000s. The plastic of choice in acetabular hip liners is now cross-linked polyethylene. Cross-linked plastic is hit with gamma or electron beam irradiation that makes the plastic harder, stronger, and reduces wear of the hip implant. Vitamin E was added to the material in the mid-2000s, which further improved hip liner longevity. (Source: Current Orthopaedic Practice )
Exactech claimed that their Connection GXL hip liner was “enhanced,” had longer wear, and was more durable, but Exactech’s GXL hip implant is wearing down early. According to a study published in Arthroplasty Today, patients with the Connection GXL hip had severe plastic wear and osteolysis happen only 5 years after initial surgery. (Source: Early failure of a modern moderately cross-linked polyethylene acetabular liner)
WHAT TO CONSIDER WHEN HIRING AN ATTORNEY TO REPRESENT YOU IN YOUR HIP REPLACEMENT LAWSUIT:
It’s important to hire an attorney based on experience. The law firm you hire should have the financial resources to litigate against giant corporations who will try to derail your lawsuit. mctlaw has the resources, expertise, technology, and knowledge to help you get the best possible outcome. Our firm is currently representing more than 500 people with defective hip replacements across the country.
Look at our map to see how many cases in each state we are representing. Click here
Our firm does not sue orthopedic surgeons. This is because the problem is with the medical device and the manufacturers, sellers, and distributors who misled surgeons to believe the product was safe. Often your surgeon can help your case.
mctlaw has focused its practice on defective hip replacement cases for over a decade.
Our attorneys are leading the litigation against hip makers across the country.
Our firm does not refer out Exactech cases. If we take on your case, we represent you.
mctlaw represents you at no cost unless we recover money from a verdict or a settlement. If you don’t get compensation, you owe us nothing.
WHAT ARE THE SIGNS OF HIP REPLACEMENT FAILURE?
Early wear of the GXL liner can lead to severe complications like osteolysis (bone degeneration), component loosening, tissue and muscle damage, and weakening or loosening of the hip implant. Symptoms of implant failure are
- Hip pain
- Stiffness
- Limited range of motion/mobility
- Difficulty walking
Source:University of Utah
Contact your doctor immediately if you’re experiencing any of these symptoms. These hip replacement problems may require revision surgery.
OSTEOLYSIS FROM HIP REPLACEMENTS
Osteolysis, or bone degeneration, is the damage and loss of bone. It’s a common complication of a bad joint replacement that happens around the hip implant.
Bone loss with hip replacements is typically caused by hip insert wear and corrosion, which leads to hip implant loosening. According to an article in Rheumatology Network, “implant loosening resulting from aseptic osteolysis accounts for more than 75% of joint arthroplasty failure.”
Early diagnosis and treatment can prevent serious injuries caused by osteolysis. MRIs, X-rays, and CT scans may be required to diagnose bone loss.
REVISION SURGERY NEEDED FOR HIP REPLACEMENT PROBLEMS
Hip revision surgery is a surgery to fix or replace a bad hip implant that is hazardous to your health. Revision surgery is more complicated than the original hip replacement because it involves removing the faulty implant. Often a surgeon performs repairs on tissue, muscle and bone damage from the first device. That can mean removing the cement used to secure the implant, the tissue surrounding it, and the dead bone before the new hip replacement can be inserted.
This video explains the complications of hip replacements, specifically a case of a failing plastic insert, and shows the complex revision surgery.
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