In February 2022, Exactech recalled all knee and ankle replacement devices implanted from 2004 to 2022. The inserts had insufficient packaging that did not protect different parts from oxygen exposure before being implanted into the human body. Oxidation causes the inserts to substantially degrade, resulting in increased chances of revision surgical procedure and pain.
If you or your loved one has suffered loss following an ankle or knee replacement implant, do not hesitate to contact Consumer Alert Now. We have many years of representing victims of defective products and can answer your questions and sensitize you about the available legal options.
Why Exactech Recalled its Ankle and Knee Replacement Implants
Exactech was founded in 1985 by a group of orthopedic doctors. Initially, the company focused on hip replacement implants but entered the knee implant market in the 1900s. And in 2017, the company started manufacturing ankle and foot replacement implants.
Since 1994, the company has repeatedly acquired 510(k) United States Food and Drug Administration (FDA) clearance for several tibial inserts and Optetrak devices. The devices are used for knee replacement surgery called total knee arthroplasty (TKA). The TKA system is a knee joint that uses polyethylene and metal-based components. It includes a femoral cap, tibial tray, tibial insert, and patellar cap. The tibial insert sits on the shin bone's top and acts like a shock absorber for the knee joint.
The TKA relieves pain due to arthritis and can be used to correct minor knee deformities or knee trauma.
In August 2021, Exactech started recalling its polyethylene liners for ankle and knee implants. In February, the company later expanded its move to include every ankle and knee insert in a nonconforming bag irrespective of the shelf life or label.
It is worth noting that the letter the implant manufacturer issued in June 2021 notified physicians that the company was phasing out its polyethylene Exactech GXL Connexion liners in Acumatch, MCS systems, and Novation hip replacement medical products. The company was transiting to XLE polyethylene liner containing Vitamin E.
The manufacturer recalled all ankle and knee replacement products manufactured between 2004 and the present, including Vantage, Truliant, and Optetrak. The firm advised physicians to stop implanting nonconforming implants and return the devices to the company.
Some of the recalled replacements include the following:
- Optetrak CR Slope Tibial Inserts
- Optetrak All-Polyethylene CR Tibial Components
- Optetrak CR Tibial Inserts
- Vantage Fixed-Bearing Linear Components
- Truliant PSC Tibial Inserts
- Optetrak Hi-Flex PS Tibial Inserts
The recall for the implants is due to a packaging failure. The inserts should not come into contact with oxygen before being implanted into the body. The Exactech plastic inserts’ packaging layers allowed airflow before insertions, which leads to premature wear and oxidation. While the inserts were in oxygen-resistant vacuum bags, they did not come with barrier layers with ethylene vinyl alcohol that enhanced oxygen resistance.
The United States Food and Drug Administration (FDA) classified the recall as Class II. In other words, the liners could result in reversible or temporary health consequences, and the possibility of severe health issues is minimal. Potential injuries linked to recalled liners include bone fracture, component fracture, and premature failure, which could result in revision surgery.
Revision surgery is an additional surgery a doctor performs to rectify joint replacement issues. Physicians recommend surgeries when an implant fails or causes symptoms like decreased mobility, infection, pain, and tissue or bone death. They are more complicated, requiring special implants and more extended surgery than primary joint replacement. They have more complication risks. Some patients require at least one revision surgery.
GXL Hip Liners Increase the Risk of Premature Wear
Although Exactech has not recalled Connexion GXL hip liners, the firm has notified physicians that patients with these liners are at an increased risk of wear under specific circumstances. Some factors contributing to premature wear include devices implanted with an anterior hip surgical procedure, high patient activity level, and large femoral head.
While the manufacturer claims that the liners work as expected and are safe, the company will phase them out of the United States market. Contact your surgeon immediately if you have experienced challenges with the hip implant. The surgeon can recommend a treatment program or discuss a device monitoring plan. Some people have brought hip replacement claims against the company over GXL liner issues.
What is the Difference Between Inserts and Liners?
Most people use the medical terms insert and liner interchangeably. Both terms refer to plastic parts made of polyethylene that function like cartilage in joint implants.
Liners are most linked with hip implants. They fit into acetabular cups, providing a cushion between the femoral head and cup. On the other hand, inserts are a flat piece of polyethylene plastics that offers cartilage replacement in knee or ankle implants.
How to Know If this Recall Affects Your Implant
Your doctors should reach out to you to book an appointment if the ankle or knee implant is among the recalled products. However, if you or your loved one is worried and fails to hear from the surgeon, you can call them to check if Exactech has recalled your medical device.
Moreover, you can check its serial number on Exactech's official website. You can find the serial number in the medical records. Additionally, you can call the manufacturer at 1-888-912-0403.
Symptoms to Watch Out For
Typically, symptoms related to polyethylene wear are linked to the release of excess particle debris from the liner or bone loss. However, some patients suffer osteolysis (bone loss) without experiencing symptoms. Be sure to contact your surgeon to know if you should monitor your medical device for potential challenges even when you do not have any symptoms.
Some of the symptoms to take note of include the following:
- Incapability to bear weight
- Pain while walking
- Noises like grinding originating from the ankle or knee implant
- Swelling in your joint
- Clinking in the hip, ankle, or knee
Call your surgeon immediately if you experience one of these signs and symptoms. Your doctor should conduct an X-ray to analyze the status of your implant. They will discuss different treatment methods, including a revision surgical procedure to replace your entire device or defective insert.
Preemptive surgery to remove the medical device is not recommended if you are not experiencing decreased mobility, pain, or other symptoms. The patient and their doctor should decide whether surgical replacement is necessary on a case-by-case basis.
What You Should Do
The manufacturer in question sent a letter to physicians concerning its recall. The notice advised doctors to stop using the implants in ankle and knee replacement surgeries. Additionally, they were required to return the remaining inventory of the implants.
The letter advised patients with the implant to contact doctors who would monitor them and analyze insert failure symptoms.
Moreover, the manufacturer offered doctors a draft letter to send to the patients.
If you have a recalled Exactech product, book a medical appointment with a doctor if she has not contacted you. You can also contact the medical expert if your hip implant has a GXL liner and you are experiencing symptoms.
The manufacturer recommends that doctors monitor individuals with recalled products for excessive wearing and potential osteolysis. Doctors use diagnostic imaging to determine tissue or bone damage and excessive wear. Your doctor should advise you of the benefits and risks of revision surgery. If you do not have any challenges, the physician can continue monitoring you because an additional surgical procedure is not advisable.
You can also contact the manufacturer directly. Exactech has hired Broadspire, a settlement adjusting firm, to oversee the reimbursement process. Patients whose doctors called them about a follow-up can contact the Exactech-Broadspire Helpline to initiate their claim.
It is worth noting that Broadspire represents Exactech’s interests. Therefore, you should not contact the helpline before consulting a skilled lawyer.
The settlement may only cover out-of-pocket expenses and costs incurred concerning evaluation and treatment for revision surgery. In other words, the settlement can fall short of the damages you suffered. You can recover damages like:
- Medical expenses
- Future medical expenses
- Lost income
- Lost earning capacity
- Pain and suffering
- Loss of life enjoyment
- Punitive damages
History of Challenges With Exactech Implants
The Optetrak knee implant was approved per the 501(k) U.S. Food and Drug Administration clearance process. It means it did not go through a comprehensive FDA approval and review. While the implant system was successful for many years following its release, it has recently had a high failure rate.
The Australian Registry also reported that Optetrak posed a high revision rate.
The manufacturer knew of these failure rates and had received reports about ankle and knee implant failures throughout the United States since 2012. According to the U.S. Food and Drug Administration’s Manufacturer and User Facility Device Experience, the implants failed significantly higher than other medical devices. The MAUDE failure reports indicate that Exactech internally knew of the incidents many years ago. Numerous complaints about the devices in Manufacturer and User Facility Device Experience that a search maxes out at 500. Therefore, it cannot demonstrate every Exactech complaint.
The failure resulted in product liability claims between 2016 and 2017 against the manufacturer by plaintiffs experiencing premature implant failure. Lawyers who filed the lawsuit did not know that the failure was due to a design feature unique to Exactech knee and ankle implants. As a result, they accused the manufacturer of failing to advise patients of the risks and instead made a recall that replaced the faulty design. However, the recall illuminated the oxygenation challenges.
Grounds for Compensation
All medical device manufacturers are responsible for ensuring that their products are safe and do not injure patients when used for their planned purpose. The obligation makes manufacturers and companies accountable for hidden manufacturing defects and design flaws that can harm patients.
Any person who had the implant after 2004 could file a product liability lawsuit against the defendant if the implant failed, leading to revision surgery and pain. Discussed below are various grounds for filing a lawsuit against the manufacturer.
Exactech Acquired Fast-Track the U.S. Food and Drug Administration Approval
The manufacturer repeatedly acquired 501(k) clearance from the U.S. Food and Drug Administration for its implant systems. The 501(k) clearance is known as “fast-track” approval; the company does not need to verify the product’s effectiveness and safety. The manufacturer usually explains the device’s significant correspondence to a pre-MDA predicate medical device. Then the FDA can clear the device for the U.S. market.
All Exactech medical devices were sold without either receiving FDA full approval or clearance or were cleared for the market under the 501(k) process. Typically, devices not thoroughly tested have defects.
Lawsuits Question Marketing
The defendant marketed Optetrak as first-in-class and claimed the product had enduring clinical results. The company promoted the device with almost 30 years of proven results and clinical success for patients due to its improved design.
Nevertheless, in reality, Optetrak performed poorly than its competitors. The 2020 Australian National Joint Replacement Registry reports that the revision rate for the total knee replacement using Optetrak exceeded the international guiding principle for recognized revision rates.
In 2012, the manufacturer proved that knee implants had high failure rates. Reports of premature failure and revisions had started accumulating in the FDA’s Manufacturer and User Facility Device Experience database.
Exactech Sales Representatives Knew of the Optetrak Challenges
As with many orthopedic implant companies, Exactech has authorized sales representatives present during the surgical procedure to offer implant components to the doctors. The company relieves the surgeons of the obligation to have on stock every part and size that doctors can require in surgeries.
The sales representatives observed many premature implant failure cases. Generally, they would take components from surgeons and return them to the manufacturer for analysis and inspection.
The sales representatives were obligated to report the observations to the Exactech medical and engineering departments. Then the departments should have conducted investigations and truthfully reported their findings to surgeons and the FDA. However, it did not occur. While the sales representative reported the matter to the manufacturer, the company continued promoting and selling the Optetrak product without advising patients, doctors, the FDA, and medical facilities of the proof that the implant was vulnerable to failure. It was not until August 2021 that the manufacturer recalled its implants.
The Manufacturer Deliberately Concealed Opterak Issues
Despite indications that Exactech was aware of the issues, its founders announced in 2017 that the private equity firm (TPG Company) was purchasing the firm. The acquisition process was concluded in 2018, converting the firm to a privately-held company. TPG Company purchased all outstanding shares at $49.25 per share.
Only a couple of years after the manufacturer became private, Exactech recalled its ankle and knee implants. Had the manufacturer initiated the recall before the firm became private, it could have significantly affected the stock and resulted in numerous lawsuits.
Exactech Recall Update
It is now months since Exactech expanded its recall of ankle and knee implants. However, most patients with defective implants are yet to receive a notification of the same.
When the company first recalled the medical devices in February, it gave surgeons a draft letter to send to patients informing them of the recall. However, beyond issuing the patient letter, Exactech has not made any effort to contact patients. That means while the recall covers thousands of patients, a considerable percentage of the patients remain unaware of the recall.
On June 14, 2022, the plaintiffs filed a petition against the defendant with the Judicial Panel on Multidistrict Litigation (JPML), requesting a Multidistrict Litigation (MDL) to be created for the defective implants. The MDL consolidates various lawsuits pending in different United States District Courts across the county.
The manufacturer did not oppose consolidation but requested that the case be transferred to the United States District Courts in either the Eastern District of Louisiana or the Southern District of New York. That means if an MDL is created, all cases will be centralized for more effective and efficient management.
What is a Mass Tort?
A mass tort is a civil action that arises when many people suffer similar injuries due to one defendant’s conduct and negligence. Please note that a mass tort is different from a class action in that the latter are several plaintiffs grouped in a single lawsuit. The main difference is the degree of control the plaintiff has in their case.
While each case is unique, there are benefits to taking legal action. A mass tort allows the victims to pool resources to mount a more effective legal challenge. By joining hands, plaintiffs can afford to hire the most qualified attorneys and experts and send strong messages to the defendants. Also, mass torts generally receive media attention, putting pressure on the defendant and helping to ensure that justice is served.
To join a mass tort, you should first speak with a seasoned lawyer to discuss the case. During your initial consultation, the legal expert will listen to you, review your medical records and determine whether you have a valid claim. If you are eligible for compensation, the lawyer will bring a complaint, collect relevant evidence, and represent you throughout your legal process.
Although the damages recovered in mass tort cases depend on the cases’ circumstances and facts, common damages awarded include:
- Medical bills (current and future)
- Lost wages
- Lost earning capacity
- Emotional distress
- Permanent disability
- Pain and suffering
How Long Does It Take to Settle a Mass Tort?
Due to the nature of a mass tort, they are more complicated than a typical personal injury claim. Additionally, since they involve huge payouts to plaintiffs, it can take months or even years before the defendant and plaintiff reach an agreement. Other factors that affect the timeline include the following:
- Finding potential plaintiffs — Typically, seasoned attorneys use social media and mass media to reach victims of the defendant’s negligence. So, it can take time to find everyone.
- Retaining expert witnesses — Depending on your case details, the lawyer can engage expert witnesses like physicians to build your case.
- Thorough investigations — Unlike a class action case, plaintiffs in a mass tort case are treated as individuals. Therefore, the attorneys should investigate all plaintiffs’ claims, gather evidence, establish facts, and determine damages.
- Finally, legal procedures like bringing the case, investigation, motions, discovery, negotiations, settlements, and appeals can affect the case resolution.
Consequently, experienced attorneys at Consumer Alert Now advise plaintiffs to do the following to expedite their case and allow it to proceed efficiently:
- File your case immediately (within your state’s statute of limitations)
- Be truthful and reveal all details about your experience to your lawyer
- Comply with legal advice
How Mass Tort Claims are Settled
Before settling a mass tort, the overseeing judge selects a bellwether case. A bellwether case is a lawsuit whose outcome determines the verdict or settlements in identical claims. Typically, bellwether cases are chosen based on the claims’ similarity and the evidence’s strength.
Please note that plaintiffs in a mass tort settlement do not split compensation recovered. Every plaintiff receives compensation based on the losses they incurred. It permits all plaintiffs to design their payments to their unique circumstances and needs. It also offers a degree of flexibility and fairness impossible with a jury verdict.
Find a Skilled Mass Tort Attorney Near Me
While thousands of patients opt for TKA, Exactech knee and ankle implants have come under increased scrutiny after high failure rates and injuries, resulting in revision surgery. Some of the alleged injuries include pain, instability, swelling, and grinding noises in the joint. Consequently, various lawsuits against the defendant have been consolidated into MDLs.
Consumer Alert Now is dedicated to holding Exactech accountable, and we are accepting cases. Our attorneys are experienced and skilled in handling mass torts cases and negotiating with the defendant settlement representatives. If you have sustained injuries from this defective medical device, you need to understand that you could be entitled to compensation, and time is the essence when filing your claim. Please contact us at 800-511-0747 at no cost. We can review your case, determine your eligibility, help you understand the lawsuit process, and ensure you receive your deserved compensation.