Exactech continues to expand its recall of its OPTETRAK Comprehensive Knee System. The Exactech recall includes all knee and ankle arthroplasty polyethylene inserts packaged in a certain kind of vacuum bag. These bags did not conform to required specifications and may allow oxygen to potentially damage the device liners. As a result, patients with the recalled devices may need revision surgery. On August 11, 2022, Exactech warned surgeons that even more devices may be impacted by the defective bags than the company originally thought.
The August 2022 warning noted that surgeons who implanted Connexion GXL liners (or nonconforming conventional UHMWPE liners) since 2004 may have patients who have been harmed. The previous warning only involved surgeons that implanted GXL liners between 2015 and 2021.
The U.S. Food and Drug Administration (FDA) classified this action as a class II recall. This means that exposure to the product may cause temporary or medically reversible health consequences, or the probability of serious health consequences is remote.
If you received a total knee replacement or a total ankle replacement since 2010, with components or inserts manufactured by Exactech, you should contact your physician to determine if your device is affected by the recall.
Once a determination is made, it is important to contact a personal injury law firm to discuss your legal options.
What Knee, Ankle, and Hip Replacements are Part of the Exactech Recall?
The defective components affected by the Exactech recall include the following:
- OPTETRAK® All-polyethylene Tibial Components
- OPTETRAK® Tibial Inserts
- OPTETRAK Logic® Tibial Inserts
- TRULIANT® Tibial Inserts
- VANTAGE® Fixed-Bearing Liner Component
- Acumatch GXL
- MCS GXL
- Novation GXL
- Exactech All Polyethylene Cemented Cup Acumatch Conventional UHMWPE
- MCS Conventional UHMWPE NOVATION Conventional UHMWPE
Since 2004, over 60,000 units each of OPTETRAK® and OPTETRAK Logic® components have been implanted in patients in the U.S. Approximately 25,000 units of the TRULIANT® inserts and 1,500 of the VANTAGE® Fixed-Bearing Liner Components implanted in patients are also affected by the recall.
If you are not sure whether you received a component affected by the recall, you should contact your physician who will check the serial number of your component against the list of affected devices provided by Exactech.
Exactech Lawsuit: The Problems with the Exactech Device
Knee and ankle replacements are made up of different parts. A standard total knee replacement is made up of four parts:
- The femoral component – a metal piece that attaches to the thigh bone
- The tibial tray – a metal piece that fits into the shin bone
- The patellar component – a piece of plastic that fits onto the kneecap
- The tibial polyethylene insert – a plastic insert that fits between the femoral component and the tibial component, and acts as the new cushion for the replaced knee joint.
A standard total ankle replacement is made up of three parts:
- The tibial component – a metal piece that attaches to the shin bone
- The talar component – a metal piece that girls into the foot bone
- The polyethylene insert – a plastic insert that fits between the tibial component and the talar component and acts as the cushion or cartilage for the replaced ankle joint.
Exactech found that one of the packaging layers for the polyethylene insert used in both the total knee replacement and the total ankle replacement did not conform to specifications. It found that the layer may allow oxygen to diffuse into the plastic insert before it is implanted in the knee or ankle. When a large amount of oxygen spreads into the plastic insert during storage, before the insert is implanted, it can lead to oxidation. Oxidation can cause the components of the implant to wear out prematurely and cause damage to the plastic after it is implanted in the patient’s body causing injury to the patient. Without the plastic insert, there is no cushioning to absorb the impact of movement causing pain and injury to the patient.
Device Recall Updates:
August 2022: Exactech sent a worldwide Urgent Dear Healthcare Professional (DHCP) notice warning surgeons of additional hip liner risks. These include premature wear in liners not included in the original recall. Exactech expanded the scope of the recall communication to include all surgeons who implanted either GXL liners or nonconforming conventional UHMWPE liners since 2004 – whereas the original notice only involved surgeons who had implanted Connexion GXL liners between 2015 and 2021.
February 2022: Exatech expands its recall to include all knee and ankle arthroplasty polyethylene inserts.
August 2021: Exactech announces a recall of its knee and ankle arthroplasty polyethylene inserts amid reports of premature wear. However, the company did not recall all inserts; it restricted the recall to only certain labels and shelf-life parameters.
June 2021: Exactech recalls its Connexion GXL hip device amid reports of premature wear caused by oxidation from the devices’ non-conforming packaging.
What are the Symptoms of an Exactech Knee, Hip or Ankle Failure?
Your surgeon may contact you if they are concerned about the ankle or knee replacement device that you received. However, do not wait to hear from your surgeon if you are experiencing any of these symptoms:
- New or worsening swelling
- Pain while walking
- Inability to bear weight
- Grinding or other noise in the knee or ankle
- Clicking in your knee, hip or ankle
Your surgeon will examine you and conduct x-rays to determine the condition of your plastic insert. The results of your surgeon’s evaluation of your x-rays and your symptoms will determine if you need revision surgery or what further action is required in your case. Then call for a free consultation with our legal team to learn if you qualify for an Exactech lawsuit.
Get a Free Case Evaluation About Your Exactech Knee Implant Parts Failure Case
Lawyers Focused on Your Recovery
Thousands of Successful Cases in State and Federal Courts
Expertise in Dozens of Key Personal Injury Case Areas
What is Knee Revision Surgery?
Knee revision surgery is a corrective surgery to replace an old knee implant in a patient. A total knee replacement (TKR) implant comprises different components to maintain the natural function of the knee. Knee revision surgery is necessary when an old knee replacement device fails. A TKR device could fail for different reasons including an adverse immune response, infection, unexplained loosening of the implant, and scar tissue build up. When a TKR implant fails, a patient may require a replacement of the entire implant, or they may only need a replacement of certain components of the implant.
According to the Encyclopedia of Surgery, TKR surgeries are highly successful, with over 90% of implants functioning well after 20 years. Out of the nearly 800,000 TKR surgeries performed in the US each year, only an estimated 22,000 knee revision surgeries are performed.
What is the Difference Between a Knee Replacement and a Knee Revision?
Both knee replacement surgery and knee revision surgery have the primary goal to relieve a patient’s pain, improve the function of their knees and their quality of life. However, the knee revision surgery is a longer, more complex procedure. It requires extensive planning to remove and replace one or more components of the TKR implant.
How Serious is Knee Revision Surgery?
Knee revision surgery is a very serious procedure, which may take several hours in some cases, and may be done in stages, depending on the cause of the TKR failure. The complexity of the case will determine how long the procedure will take, and how fast the patient can recover. Every surgery carries some risk and knee revision surgery is no different.
The possible risks involved include:
- Infection in the wound
- Poor wound healing
- Excessive bleeding
- Anesthesia complications
- Damage to blood vessels or nerves during surgery
- Bone fracture during surgery
- Bone loss
- Heart attack or lung complications during surgery
What to Do if You Are Having Problems with Your Knee, Hip or Ankle Implants
If you are experiencing pain or swelling of your ankles, hips or knees, there may be a problem with your implants. Other symptoms of implant failure are instability, clicking or grinding noise, or inability to bear weight. If you are experiencing any of these symptoms, you should see your surgeon as soon as possible to avoid worsening your condition. Your surgeon will run some diagnostic tests including x-rays or MRIs to make a determination about the condition of your implant.
If your surgeon determines that you need to have revision surgery because of a failed defective implant, you may be entitled to compensation. You should speak with a defective device lawyer who can give you more information about filing an Exactech recall lawsuit, your rights, and legal options.
What Exactech Polyethylene Patients Should do
If it is determined that you have an Exactech knee, hip or ankle product that is included in the recall, you have several options. Exactech has retained Broadspire, a settlement adjusting company, to oversee the claims reimbursement process. Patients who have been contacted by their surgeon about a follow-up are directed to contact the Exactech-Broadspire Helpline to initiate a claim.
It is important to keep in mind the Broadspire represents the interests of Exactech, therefore, it is not advisable to contact the Exactech-Broadspire Helpline before speaking with an attorney about your case.
The Exactech-Broadspire settlement only covers reimbursement for out-of-pocket expenses and costs incurred in relation to evaluation and treatment for revision surgery. A reimbursement settlement assessed by Broadshire may fall far short of the actual damages you suffered.
You may be entitled to more compensation than Exactech is offering. You may be able to recover financial compensation for damages including:
- Lost wages if you missed or will miss work because of your ankle or knee replacement
- Pain and suffering
- Related medical expenses
How much is an Exactech knee replacement lawsuit worth?
Often in personal injury cases, lawyers look at past settlements and verdicts to inform the value of a client’s claim. This is because past case values are a good gauge of the general value of a particular type of case. Nevertheless, we treat our clients independently based on their specific circumstances. The severity of the claimant’s injuries, complications suffered by the claimant, and other specific circumstances surrounding their injury are all factored into the value of claimed damages.
While there have been no reported settlements or verdicts in an Exactech knee and ankle implant case, base awards in recent hip replacement cases fall within the $150K to $300K range. Typically, knee implant cases have a lower compensation value than hip replacement cases but there are no hard-and-fast rules about this.
Every device litigation case is different and every individual claim is different. How much compensation you can recover will depend on the specific facts of your case. Past settlements are no guarantee of future awards, but we at Anapol Weiss work hard to get our clients the highest settlements possible in their case.
Speak to a Lawyer About Your Next Steps
If you had a knee or ankle replacement with a recalled Exactech product, you should speak to a lawyer about your legal options. The defective device team at Anapol Weiss has successfully resolved such cases on behalf of thousands of individual clients. We are ready to help you. We offer free initial consultations.
Get Help from a Law Firm Litigating Against Defective Devices
Anapol Weiss has spent decades taking on big companies like Exactech. Our personal injury lawyers have obtained billions of dollars in successful verdicts, settlements and judgments on behalf of clients in a variety of mass tort, class action, and medical malpractice lawsuits.
Our Partner, Thomas Anapol, was part of the team that negotiated a $1.4 Billion settlement on behalf of recipients of Stryker Rejuvenate and ABG II defective hip devices. The settlement provided for a base award of $300,000 per case, the highest base settlement in any metal-on-metal hip implant litigation to date.
Our Partners, Thomas Anapol and James Ronca, have been appointed to lead multiple Orthopedic device implant cases over the years including Zimmer NexGen knees, DePuy ASR and Pinnacle hips, Biomet hips and Stryker ABG/Rejuvenate and V40 hips.
The firm has successfully resolved cases on behalf of thousands of individual clients.
If you have been affected by the Exactech recall, our medical device team is ready to help you. We offer a free consultation, so call us today to speak with a member of our legal team.