What You Need To Know About the Exactech Hip Replacement Recall
The use of hip replacements has grown in popularity in recent years in the United States. Conditions like osteoarthritis, rheumatoid arthritis, fractures, and other debilitating musculoskeletal conditions that used to sideline individuals now allow them to retain their mobility and not experience pain or discomfort when resting, thanks in large part to the widespread use of hip replacement implants.
However many benefits that have come with the increasing use of these implants, there have also been some setbacks in terms of recalls of them. One of the latest recalls centers around the Exactech hip replacements. Read on where we’ll share what you need to know about the Exactech hip replacement recall.
How the Exactech Hip Replacement Device Gained FDA Approval
The U.S.-based Exactech, Inc. has become one of the world’s leading manufacturers and distributors of artificial hip replacement devices since the orthopedic-founded company went into business in the 1980s.
Exactech’s Novation Crown Cup hip replacement device featuring the Connexion GXL liner was first introduced on the market in the U.S. in 2007. This debut came after the hip implant device received fast-track approval from the U.S. Food and Drug Administration (FDA). This unique FDA 510(k) clearance “green lighting” process allows medical device manufacturers to launch their products without having to first submit to a comprehensive examination of a product’s design.
How the Exactech Hip Replacement Device Works
Exactech’s Novation Crown Cup is the company’s most popular hip replacement device, as it has a hemispherical titanium cup that functions similarly to a hip socket. The Connexion GXL liner insert, made of polyethylene plastic liner, is located inside the acetabular portion of the device (its cup-shaped socket). The role of that insert liner is to absorb any friction as users move about.
When Did the Exactech Hip Replacement Recall Happen?
According to the FDA, manufacturer Exactech, Inc. recalled its hip replacement devices in June of 2021 due to them containing a defective component, their Connexion GXL liner.
Why Did the Exactech Hip Replacement Device Get Recalled?
When announcing the recall, the surgical implant company reported that the Connexion GXL liner that lines the hip replacement device was susceptible to premature failure. Exactech, Inc. conceded that defective manufacturing and poor packaging were responsible for the recall.
Exactech had already received an abnormally high amount of reports from hip replacement patients and their physicians regarding the premature deterioration or failure of the device’s polyethylene liner by the time of the recall announcement. Despite this, the recall notice issued by Exactech listed the reason for it as “unknown.”
Exactech continued investigating the matter after launching the hip replacement recall and later publicly identified what they believed to be the source of the problem. They discovered that the vacuum seal package they shipped the Connexion GXL liners in lacked a layer of material to prevent the entry of oxygen, which caused the oxidation and, thus, degradation of the Connexion GXL liners.
This same Connexion GXL liner is also apparently used in manufacturing Exactech’s ankle and knee replacement devices and has also resulted in their recalls.
Signs of Exactech Hip Replacement Device Failure
While we’ve spoken about discomfort or pain being common symptoms patients have reported after their implantation with the defective hip replacement device, some other problems others have encountered include:
- Joint swelling
- Instability when attempting to bear weight
- Grinding or clicking noises in the hip joint
How Many People Are Affected by This Recall?
An apparent 130,000 had already had the defective hip replacement device implanted in them by the time the recall had been issued.
Obligations Medical Device Manufacturers Have to Patients
Product designers, manufacturers, and distributors are obligated to take the necessary steps to verify its safety or any potential contraindications surrounding its use, and to identify and resolve any problems before its release on the market. That oversight didn’t happen in this case, thus resulting in the problems that necessitated this recall.
Exactech Hip Replacement Patients’ Rights
Arkansas product liability laws and similar statutes in other jurisdictions allow consumers who’ve been harmed while using a dangerous or defective product to file a lawsuit against manufacturers for the harm they’ve suffered due to their negligence.
Patients who allege that they’ve suffered unanticipated harm after the implantation of the Exactech hip replacement must prove their case in civil court. Evidence a patient, and consequentially a plaintiff in the civil case, may produce in a product liability case such as this may include medical reports that show that they:
- Received an Exactech hip replacement device outfitted with the Connexion GXL liner that’s subject to the recall
- Have reported pain or discomfort that extends beyond the anticipated recovery period that doctors have suggested requires regular pain management intervention
- Haven’t experienced a reduction in painful symptoms despite having participated in physical therapy and home exercises
- Have needed to seek mental health counseling or other emotional or behavioral treatment to cope with the pain or change in lifestyle that the defective device has caused
- Require a revision surgery to address the malfunctioning artificial hip joint device
Your product liability lawyer at McMath Woods P.A., who regularly handles dangerous and defective medical device cases, may also recommend that you compile medical bills, journal entries, and other documentation in building a strong case against Exactech, Inc.
Compensation Exactech Hip Replacement Device Patients May Be Eligible For
Patients who file suit against Exactech, Inc. for their defective manufacturing of hip replacement devices may be eligible for compensation to cover damages such as:
- Any costs leading up to and associated with the removal, replacement, or repair of their hip replacement device, including the revision surgery itself and rehabilitative care
- Noneconomic damages, including ones for mental anguish, pain and suffering, and loss of consortium or enjoyment of life, endured due to their pain after the implantation with the device
- Any losses of income sustained by having to miss work due to the failure, replacement, and rehabilitation from the implantation of the defective device
While medical bills, as described above, may aid in documenting the amounts associated with any economic damages you’ve incurred, they’re not as helpful in assigning a monetary loss to noneconomic damages. This is where the guidance of an experienced personal injury lawyer can come in handy. They’ll know how to justify demands for damages like these.
Settlement Awards Expected in Exactech Hip Replacement Lawsuits
Little Rock personal injury attorneys like ours tend to steer clear from giving estimates of monetary awards in product liability cases like these. We do so because there’s a lot that can go into determining a settlement amount, including:
- How quickly the device failed you: Many patients who undergo hip replacement surgery expect to experience anywhere from a decade to a lifetime of pain-free mobility after receiving their implant, depending on the device, use, and when it’s implanted. Health insurance companies may limit how much or how often patients receive or if the insurer pays for such a procedure. A patient’s decision to move forward with the operation may come down to a cost-benefit analysis associated with the device not lasting its expected lifetime.
- Employment status: Whether you’re actively employed or retired may impact your settlement amount. So too, may the nature of your job, such as whether your ability to continue with it was contingent upon you enjoying relatively pain-free mobility.
- Details surrounding your pain: This includes the extent of your pain and how long it went on for.
- Your age: Your age at the time of the onset of your device-related pain or discomfort will likely be weighed by the defendant when making an offer to settle your case. Younger patients whose enjoyment of life may be adversely impacted for longer may be eligible for more compensation than an elderly patient who may have already experienced a diminished quality of life.
While we can’t give you an exact amount you can expect to receive as an award in your product liability case against Exactech, Inc., we can give you a better idea after learning more about your unique situation with the hip replacement device.
Filing Deadlines in Arkansas Product Liability Cases
Ark. Code Ann. § 16-116-203 outlines how Arkansas residents have three years from the onset of their injury to file a product liability case, such as against a defective medical device manufacturer. It may be reduced to two years if a medical malpractice claim accompanies it. A 4-year statute of limitations may apply to any warranty-related product liability claims subject to the Uniform Commercial Code per Ark. Code Ann. § 4-2-725.
Our Arkansas state statutes describe how the statute of limitations begins running down once a patient first becomes aware of the onset of their injury and connects it to their use of a defective product.
Some additional exceptions to the above-referenced rules may apply, which we can discuss with you during your free case evaluation with our McMath Woods P.A. legal team. You may lose your ability to recover compensation for the harm you’ve suffered unless you meet the established filing deadlines.
How We Can Help You if You Have Experienced Pain After Receiving an Exactech Hip Replacement
Now that you’re aware of the nature of the Exactech hip replacement device recall, it’s imperative to take legal action as soon as possible to preserve your right to compensation.
In our experience, few individuals who have received a hip replacement readily know what brand of device they’ve received. That’s why we ask you to request and bring any medical records, insurance explanation of benefits, and doctors’ or surgical bills you may have when you meet with an attorney from our Little Rock law firm. That way, we can assess whether you received an Exactech or perhaps another recently recalled hip replacement device. Doing this also allows us to verify the date of your receipt of the device.
If you have any reports substantiating the onset of unexpected pain in the months or years following your anticipated recovery from the surgery, that can be helpful for your product liability lawyer to review during your initial meeting as well.
Holding negligent manufacturers liable for jeopardizing patients’ lives in their rush to get their products to market is necessary to ensure our collective health and safety. Your taking a stand against Exactech, Inc. for their distribution of defective artificial hip replacement devices is for your and everyone else’s benefit.
We’re eager to discuss your potential liability claim with you. We offer a no-obligation consultation to do just that with one of our Little Rock personal injury lawyers here at McMath Woods P.A. Contact us now to schedule that meeting to begin protecting your rights.