Exactech, a manufacturer of joint replacement systems, announced in August 2021 that it was recalling polyethylene liners for some of its knee and ankle implants. This recall was after the company’s notice to physicians in June 2021 that it was phasing out liners used in some of its hip replacement products, although those liners were not being recalled.
In February 2022, the company expanded its voluntary recall to include all knee and ankle replacement polyethylene liners, regardless of label or shelf life. These liners are being recalled because it has been discovered that the packaging allowed the liners to be exposed to oxygen, which caused severe degradation and early failure. Nearly 150,000 of these recalled inserts have been implanted by surgeons in the U.S. since 2004.
The Food and Drug Administration has designated the recall a Class II recall, meaning the liners may have a small risk of temporary or reversible health consequences. Patients who experience failures of their ankle and knee liners may suffer from bone loss and require revision surgery, a procedure to replace an old, worn-out artificial implant. It’s considered a more complicated procedure than the initial joint replacement surgery, as revision surgery takes longer and requires specialized tools and implants.
Recalled Exactech Systems
Exactech has recalled all knee and ankle replacement liners from its Optetrak, Truliant, and Vantage brands manufactured beginning in 2004. Surgeons have been advised by the company not to implant these liners and to return them to Exactech. Recalled systems include the following:
- Optetrak All-Polyethylene CR Tibial components
- Optetrak All-Polyethylene PS Tibial components
- Optetrak CR Tibial inserts
- Optetrak CR Slope Tibial inserts
- Optetrak PS Tibial inserts
- Optetrak Hi-Flex PS Tibial inserts
- 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 CR Tibial inserts
- Truliant CR Slope Tibial inserts
- Truliant CRC Tibial inserts
- Truliant PS Tibial inserts
- Truliant PSC Tibial Inserts
- Vantage Fixed-Bearing Liner component
Exactech has also announced that the Connexion GXL Hip liner has a risk of higher wear rates. A small percentage of patients have demonstrated earlier wear on their liners three to six years following hip replacement surgery.
Timeline of the Exactech Knee, Ankle, and Hip Replacement Lawsuits
2002-2008: Department of Justice sued Exactech for paying surgeons to convince providers to use Exactech’s hip and knee implants. Many false Medicare claims were submitted and the case was settled in 2010.
2004: Exactech packaged their liner products in non-conforming bags that lacked a secondary barrier layer of ethylene vinyl alcohol (EVOH). Without EVOH to augment the inserts’ oxygen resistance, the devices were subject to oxidation and premature wear when implanted.
2020: Whistleblowers sued Exactech claiming the company blatently provided defective knee replacements to VA, Medicare and Medicaid beneficiaries.
June 28, 2021: Exactech recalls Connexion GXL hip replacement devices after patients report premature wear of the replacements due to oxidation caused from a non-conforming packaging of the devices.
August 30, 2021: Exactech initiates Class 2 recall of knee and ankle arthroplasty polyethylene inserts
February 7, 2022: Exactech expands the August recall for knee and ankle replacements to include all knee and ankle arthroplasty polyethylene inserts packaged in non-conforming bags regardless of label or shelf life.
April 26, 2022: Foxwell et al v. Exactech, Inc. et al was initiated. Filed in the U.S. District Court for the District of Maryland, the plantiff alleges that the manufacturer knew that the Exactech Knee Replacement the plantiff received was defective and lays out the entire history of the Defective Exactech Knee Replacement.
August 2022: Exactech lawyers have filed a motion with the Judicial Panel on Multidistrict Litigation (JPML) asking for the creation of a new Exactech class action lawsuit in the Eastern District of New York. All Exactech recall lawsuits in federal court will be consolidated into the Multidistrict Litigation (MDL) The total number of pending Exactech cases in federal courts is up to 36. This will certainly increase the likelihood that the JPML will grant the motion and create a new MDL for the Exactech recall cases.
Common Issues Caused by Defective Exactech Knee and Ankle Replacements
Defective Exactech replacement knee and ankle parts can cause issues when the liner prematurely wears out, leaving nothing to cushion the impact from walking. This can lead to issues such as the following:
- Debris particles accumulating in the joint due to the wearing and breaking down of the liner
- Bone loss
- Disintegration of bone cells, known as lysis
- Pain, especially when walking
- Restricted range of motion, often caused by swelling of the joint
- Loosening of the replacement joint from the bone
- Accelerated fatigue of artificial joint components, resulting in cracking or fracturing of the components
Eventually, a defective liner will require an individual with an artificial knee or ankle to undergo revision surgery.
Common Symptoms of Exactech Knee and Ankle Replacement Failures
Replacement knee or ankle equipment failure can lead to bone loss, fractures, and particle debris from a degrading liner.
If your Exactech knee or ankle replacement liners are failing, you might experience the following symptoms:
- A clicking feeling or sound in the replaced joint
- Inability to bear weight with the joint
- Instability in the replaced joint
- Grinding sounds or other noises from the replacement
- Pain while walking
- Swelling of the joint
You should see your doctor if you are experiencing any of these symptoms. However, some cases of bone loss do not cause any noticeable symptoms. Your doctor may need to perform scans of the replaced joint to determine if the artificial joint liners are experiencing excessive or accelerated wear and tear and are causing you injury or other medical harm.