Exactech Knee and Ankle Replacement Systems Recall
The Whitley Law Firm is currently investigating defects related to polyethylene joint replacement inserts. Earlier this year, Exactech announced a recall on components in a number of its knee replacement systems and ankle replacement systems.
Patients who underwent joint replacement surgery with knee or ankle systems made by Exactech are advised to contact the manufacturer and/or their orthopedic surgeon promptly, as well as seek medical attention for new or worsening pain, immobility, and other issues associated with defective knee and ankle replacement components. In addition, you should speak to a defective medical device attorney as soon as possible about your legal rights.
The Whitley Law Firm has extensive experience advocating for consumers who have been harmed by defective medical devices and other faulty products. Please call (919) 785-5000 today for a free consultation.
What Exactech Devices Are Included in the Recall?
A total of 147,732 devices are included in the Exactech recall. The recalled devices were introduced in the United States as early as 1994, although the majority were introduced in the last 12 years.
The Exactech recall is centered on tibial inserts and components used for total and partial knee replacement, as well as total ankle replacement. Components used in the following systems are included in this recall:
- Total Knee Replacement Systems:
- OPTETRAK Logic® tibial inserts
- OPTETRAK® tibial inserts and all-polyethylene tibial components
- TRULIANT® tibial inserts
- Partial Knee Replacement Systems:
- OPTETRAK® Unicondylar Tibial Components
- Total Ankle Replacement Systems:
- VANTAGE® Fixed-Bearing Liner Component
Why Are Exactech Knee and Ankle Replacement Components Being Recalled?
Exactech instituted a recall on its knee and ankle replacement components after discovering that the packaging layer for the polyethylene insert failed to meet specifications. As a result, the plastic component is at risk of dangerous oxidation.
In Exactech total and partial knee replacement systems, the tibial insert serves as a substitute for the cartilage between the femur and the tibia (a.k.a., the shin bone). Although the tibial insert is subject to wear and tear over time, oxidation from improper packaging can accelerate degradation of the polyethylene component. Revision surgery may be necessary to repair or replace the damaged implant.
Similarly, the plastic insert in the VANTAGE® Fixed-Bearing Liner Component total ankle replacement system replaces the cartilage between the shin bone and the talus (the bone in the foot making up the lower portion of the ankle). Damage to the polyethylene component decreases its lifespan, resulting in decreased performance and potentially necessitating revision surgery.
What Symptoms Are Associated with Defective Exactech Knee and Ankle Replacement Components?
Patients who underwent total or partial knee replacement with defective polyethylene tibial inserts and components from Exactech may experience:
- New or worsening swelling in the knee
- Knee pain when walking
- Lack of stability
- Difficulty or pain when putting weight on the replaced knee
- Grinding, popping, and/or clicking sound in the replaced knee
Patients who underwent ankle replacement surgery with a defective plastic component may experience similar symptoms, albeit localized to the ankle:
- New or worsening swelling in the ankle
- Pain in the ankle when walking
- Lack of stability
- Difficulty or pain when putting weight on the replaced ankle
- Clicking, popping, and/or grinding sound in the area of the ankle
At present, the affected Exactech devices are subject to a class II recall. The FDA defines a class II recall as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
The defective Exactech knee and ankle replacement inserts do not pose an immediate danger to patients. However, the oxidation of components can lead to a number of adverse effects that may ultimately require surgery to correct.
How Does the Exactech Recall Affect Me?
Exactech is working with orthopedic surgeons and surgical facilities across the country to identify patients who underwent knee or ankle replacement with the defective components. You may have received a letter from your surgeon or the facility where your joint replacement was performed informing you of potential issues.
If you experience any of the symptoms associated with degraded knee or ankle replacement devices, you should make an appointment with your doctor as soon as possible. Professional assessment is necessary to determine if additional treatment (up to and including revision surgery) is needed.
Exactech has also set up a hotline patients can call if they suffer complications from premature wear of a knee replacement or ankle replacement device. You can initiate a claim for out-of-pocket expenses by calling the Exactech hotline with the following information:
- The date of your knee replacement or ankle replacement surgery
- The name of the surgeon who performed the procedure
- The serial number for the joint replacement device
Affected patients will be assigned a claim number. It is crucial to keep track of any and all expenses you incur related to diagnosis and treatment of the defective device.
What Compensation Can I Recover for Damages Related to Defective Exactech Components?
You may be entitled to compensation beyond the reimbursement of out-of-pocket costs currently offered by Exactech. Attorneys at the Whitley Law Firm will review the details of your case thoroughly to determine what additional damages you may be due.
Compensation our lawyers may be able to recover in a defective medical device claim includes:
- Current medical expenses related to your knee replacement or ankle replacement defect
- Future medical expenses, including revision surgery, rehabilitation, etc.
- Lost wages
- Loss of earning capacity, if your ability to work is impacted long-term
- Pain and suffering
Exactech may be liable for additional damages if you have suffered serious pain, loss of mobility, and other issues due to a defective knee replacement or ankle replacement implant.
We count on the manufacturers of medical devices to design their products for maximum efficacy and safety. You have legal rights if the failure of a product adversely affects your health or the health of someone you love.
At the Whitley Law Firm, we are committed to protecting the rights of consumers in a wide range of product liability cases. We make it our mission to pursue fair compensation for those who have been wronged and, through our advocacy, create a safer world for everyone.
Please call (919) 785-5000 today for a free consultation if your Exactech knee or ankle replacement has been recalled. The Whitley Law Firm serves clients in North Carolina and nationwide from offices in Raleigh, Kinston, and New Bern.