Exactech, Inc., a company which manufactures products for joint replacements, has issued a recall of its knee and ankle polyethylene liners in the United States, as the inserts may fail and require revision surgery to replace. Since 2004, approximately 147,000 inserts have been used in joint replacement seugeries, which means thousands of people could potentially be affected. Phelan Petty is currently reviewing these cases. Please contact us to learn more about your options.
Which Exactech products have been recalled?
Exactech has issued recalls for its Ultra-High Molecular Weight Polyethylene (UHMWPE) Knee and Ankle Polyethylene Inserts, sold in the United States:
|System||Component Description||Phase 1 Recall Units||Phase 2 Recall Units||Implanted units in US since 2004|
|OPTETRAK®||OPTETRAK® All-polyethylene CR|
OPTETRAK® All-polyethylene PS Tibial Components
OPTETRAK® CR Tibial Inserts
OPTETRAK® CR Slope Tibial Inserts
OPTETRAK® PS Tibial Inserts
OPTETRAK® HI-FLEX® PS Tibial
(referred to as “Logic” below)
|OPTETRAK Logic® CR Tibial Inserts|
OPTETRAK Logic® CR Slope Tibial Inserts
OPTETRAK Logic® CRC Tibial Inserts
OPTETRAK Logic® PS Tibial Inserts
OPTETRAK Logic® PSC Tibial Inserts
OPTETRAK Logic® CC Tibial Inserts
|TRULIANT®||TRULIANT® CR Tibial Inserts|
TRULIANT® CR Slope Tibial Inserts
TRULIANT® CRC Tibial Inserts
TRULIANT® PS Tibial Inserts
TRULIANT® PSC Tibial Inserts
|VANTAGE®||VANTAGE® Fixed-Bearing Liner|
Exactech also recalled its Connexion GXL acetabular liner for hip replacements, citing the same risk of failure. You can read that letter in full here.Read the full letter regarding these implants here.
Exactech issued an urgent recall of these devices in June 2021, and the Food & Drug Administration (FDA) issued a Class 2 recall of all devices in July 2021. A Class 2 recall indicates that the “use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences.”
Why did Exactech recall its knee and ankle inserts?
Exactech’s polyethylene inserts are made of plastic, and they are inserted in between the metal components of knee and ankle replacements. When these inserts are shipped to hospitals and surgical centers throughout the country, they are shipped in vacuum-sealed bags to protect them. However, Exactech discovered that the bags they used were “out-of-specification;” they did not contain a secondary barrier lawyer that helped to protect the inserts from oxygen.
The use of these non-conforming bags may enable increased oxygen diffusion to the UHMWPE (ultra-high molecular weight polyethylene) insert, resulting in increased oxidation of the material relative to inserts packaged with the specified additional oxygen barrier layer. Over time, oxidation can severely degrade the mechanical properties of conventional UHMWPE.
To sum, the packaging had a defect which may have allowed oxygen to get into the bags. Oxygen can degrade the parts, rendering them dangerous.
Other lawsuits filed against Exactech
Exactech implant lawsuits have been going on for years. The FDA’s Manufacturer and User Facility Device Experience (MAUDE) shows hundreds of complaints about these products failing, citing “pain” and “infection” in users stemming from 2016-2017. A 2012 study published in Orthopaedics & Traumatology found that some OPTETRAK® knee replacements failed after 25 months.
This failure is due to a design flaw in its tibial tray. Instead of recalling the defective devices then, Exactech engaged in a “silent” recall, where it replaced the devices with a new, updated version.
In 2020, a qui tam lawsuit was filed against Exactech, accusing the company of violating the False Claims Act and Anti-Kickback Statute. In the lawsuit, the Relators – two former Exactech salespeople and a physician formerly employed by Exactech – allege that “No later than 2008, Exactech learned that the Finned Tibia Tray failed in approximately 30-35% of patients within the first three years of implantation. This failure rate is ten times the failure rate of comparable knee replacement devices and six times the failure rate at which a device should be voluntarily recalled.”
What are the risks to patients with Exactech inserts?
If a patient has a defective Exactech liner insert in his or her knee or ankle replacement, that insert can cause the entire replacement device to fail. Additional problems include:
- Accelerated wear
- Component fatigue, leading to cracking/fracturing
- Debris production
- Osteolysis (bone loss)
- Broken or fractured bones
- Instability in the knee or ankle
- Inability for the replacement to bear the weight of the patient
- Swelling around the joint
Each of these issues can necessitate revision surgery, which poses an additional set of risks such as reactions to anesthetics, blood clots, nerve or blood vessel damages, pulmonary embolism, and infection. Revision surgeries are more dangerous to patient than the original surgery, in most cases.
Furthermore, if pieces of the device break off and enter the bloodstream, they can trigger a potentially life-threatening inflammatory response called sepsis. They can also cause internal damage to bones, nerves, arteries, and veins.
What should I do if I have an Exactech insert in my knee or ankle replacement?
If you have an Exactech insert, you should contact your doctor immediately and request an appointment. You may nee dot have your insert replaced. Exactech is currently offering reimbursement for claims stemming from its products’ failures.
You may be entitled to additional compensation outside of reimbursement. The Richmond-based product liability attorneys of Phelan Petty are currently accepting cases on behalf of knee and ankle replacement recipients who have suffered losses because of a defective insert. You may be entitled to damages for:
- Medical costs, including expenses related to treatment and/or revision surgery
- Lost wages
- Pain and suffering
In some cases, claimants may be entitled to punitive damages.
If you have had a knee or ankle replacement since 2004 and have one of Exactech’s polyethylene inserts in your device, and have suffered losses and/or had to undergo a revision surgery, Phelan Petty may be able to help. We have decades of experience representing injury victims in complex litigation for defective medical devices. Please call 804-980-7100 or fill out our contact form to schedule a free consultation. We are based in Richmond and serve the entire Commonwealth of Virginia.