Exactech has issued several recalls on its joint replacement devices. Click the links below for information on a recalled device:
– Exactech Knee and Ankle Devices Recalled Following Alarming Failure Rates
– Exactech Hip Replacement Devices Recalled Twice Following Alarming Failure Rates
Defective Medical Device Lawyers Handling Claims The Involving Exactech Recall Joint Replacements Lawsuit
Burg Simpson is investigating claims on behalf of individuals who sustained serious injuries as a result of Exactech knee replacements, ankle replacements, and hip replacements. You may be entitled to compensation if you suffered any of the following after receiving one of these devices:
- Swelling of the joints
- Inability to bear weight
- Device loosening or failure
Compensation may be available to pay for revision surgery and other costs associated with malfunctioning Exactech knee, ankle, and hip replacement devices. A knowledgeable defective medical device lawyer at Burg Simpson can help with your claim!
Please fill out the form on this page or call 888-895-2080 today for a free consultation. Burg Simpson handles dangerous drug and medical device claims on behalf of clients nationwide.
Exactech Knee and Ankle Devices Recalled Following Alarming Failure Rates
In August 2021, Exactech initiated a Class 2 Recall of multiple knee and ankle replacement devices:
- OPTETRAK Knee
- OPTETRAK with Logic Components Knee
- TRULIANT Knee System
- VANTAGE Ankle Systems
These Exactech knee and ankle replacements have plastic components made of Ultra High Molecular Weight Polyethylene (UHWMPE). The plastic components are supposed to be packaged and distributed to hospitals and/or surgeons in oxygen-resistant vacuum bags that contain a secondary barrier. This second barrier contains ethylene vinyl alcohol (EVOH) – a compound that assists in keeping oxygen away from plastic components.
Exposure to oxygen can cause a process called oxidation. Over time, oxidation can damage the structural integrity and mechanical properties of the plastic components of these knee and ankle devices.
Since 2004, Exactech has been distributing these plastic components in bags that failed to meet required specifications. These bags did not contain the secondary barrier to protect from oxygen exposure and subsequent oxidation.
In the company’s letter to doctors explaining the Exactech recall, the company suggests oxidative damage to the plastic components may accelerate “wear debris production and bone loss, and/or component fatigue/cracking/fracture all leading to corrective revision surgery.”
Currently, the Exactech recall involves over 147,700 improperly packaged Exactech devices subject to oxidation have been implanted in patients across the United States. Data from European and Australian medical device registries have reported higher than expected rates of failures and revision surgeries for the OPTETRAK Knee System. Although the exact root cause has not been determined, Exactech has acknowledged that out-of-specification packaging causing oxidation to the plastic components may be related to these failures.
How Burg Simpson Can Help With Your Exactech Recall Lawsuit
Our mass tort attorneys are highly experienced in medical device litigation. We have the resources and experience to handle complex lawsuits and help get you the compensation you deserve.
If you or a loved one has suffered injuries and required revision surgery due to a dangerous medical device such as the OPTETRAK Knee System, OPTETRAK Logic Knee System, TRULIANT Knee System, or VANTAGE Total Ankle System, call us today at 888-895-2080.
Exactech Knee and Ankle Devices Recalled
Certain lots of the following Exactech knee and ankle devices are subject to this recall:
- OPTETRAK Comprehensive Knee System with All-Polyethylene Tibial Components
- OPTETRAK Comprehensive Knee System with HI-FLEX Polyethylene Tibial Components
- OPTETRAK Comprehensive Knee System with OPTETRAK Logic All-Polyethylene Tibial Components
- OPTETRAK Comprehensive Knee System with OPTETRAK Logic Modular Tibial Components
- VANTAGE Total Ankle System with Fixed-Bearing Polyethylene Liner Component
- TRULIANT Knee System with TRULIANT Tibial Inserts
If you have your device serial number, you can search your serial number on Exactech’s website to determine if your device is subject to an Exactech recall lawsuit.
Real-World Data on OPTETRAK Knee Systems
The OPTETRAK Knee System was introduced in 1992 and has been used throughout the world. In many countries, long-term follow-up of patients and patient outcomes are monitored by medical device registries.
In Australia, follow-up with patients receiving total knee replacements with the OPTETRAK system showed a significantly higher revision rate when compared to other companies’ total knee replacement systems. This means more patients who received OPTETRAK needed to have a second surgery to fix or repair the failure of their Exactech knee replacement. A similar finding was observed in the United Kingdom registry. In the New Zealand medical device registry, data showed 9.5% of patients with a primary OPTETRAK total knee replacement required a revision.
Exactech has acknowledged that the data in these medical device registries of required revision surgeries for their recalled knee devices were related to accelerated UHMWPE/polyethylene wear which occurred at higher rates than other companies’ total knee replacements.
Exactech Hip Replacement Devices Recalled Twice Following Alarming Failure Rates
Following higher than normal failure rates, the Exactech recalls issued affects the following hip replacement devices:
- Connexion GXL
- MCS GXL
- MCS Conventional UHMWPE
- Novation GXL
- Novation Conventional UHMWPE
- Acumatch GXL
- Acumatch Conventional UHMWPE
- Exactech All Polyethylene Cemented Cup
Exactech issued the first recall in July 2021 after receiving reports of failure due to early signs of wear on the polyethylene components of its devices. Exactech expanded this recall in August 2022 to include additional hip devices after finding that many of its hip devices had been improperly packaged without a specified oxygen barrier since 2004.
As with the Exactech knee and ankle replacement device recalls discussed above, the company acknowledges that improper packaging of its hip devices can cause oxidative damage to the components of the recalled hip replacement devices. This can result in osteolysis (progressive degeneration) of the proximal femur and the socket of the hip bone (i.e., the acetabulum). This can result in pain, loss of mobility, and an increased risk of failure and/or fracture of the hip device. Accelerated wear also tends to require surgery to replace the failed device and repair the damage it caused to surrounding bone and tissue.
What’s My Next Step?
If you or a loved one has been injured by a recalled Exactech hip, knee, or ankle replacement, act now and contact Burg Simpson. You have limited time to file an Exactech recall lawsuit after your injury. If you wait too long, you may not be able to secure just compensation for your injuries.
Call Burg Simpson today at 888-895-2080!
We offer a free, no-obligation case evaluation. We pay the cost of obtaining your medical records, any expert reviews, and court filing fees. We only receive a fee for our work if the medical device company pays your claim.
Why Choose Burg Simpson for Your Medical Device Claim?
Good Lawyers. Changing Lives.®
With our resources and experience, we can provide the level of service that smaller firms often cannot match while still retaining the personal touch you deserve. We maintain close relationships with many other national law firms and expert consultants to ensure we can offer you quality legal representation.
Burg Simpson has more than 65 lawyers and has helped more than 10,000 clients in our 40-year history. Burg Simpson was named a #1 Products Liability Law Firm in the U.S. by Martindale-Hubbell.
If you or a loved one has been injured by a recalled Exactech knee, ankle, or hip replacement device, contact one of our experienced mass tort lawyers today by calling 888-895-2080 or filling out our FREE case evaluation form.