Have you experienced pain or discomfort after having an Exactech joint replacement device implanted? You might be entitled to compensation for your injuries. Exactech has issued a recall on certain joint replacement devices manufactured between 2004 and August 2021. Defective packaging bags caused oxidation that reportedly led to the accelerated wear and ultimate failure of the devices.
Individuals who have suffered harm, including worsening pain or swelling, after having an Exactech knee or ankle replacement are strongly encouraged to contact Levin Law, P.A. to schedule a free, no-obligation consultation. Harmed individuals may be entitled to compensation through a personal injury lawsuit against the manufacturer. Call (305) 402-9050 to discuss your rights.
What Is the Exactech Recall?
In 2021 and 2022, Exactech recalled hundreds of thousands of knee and ankle polyethylene inserts. The joint replacement devices were implanted in thousands of patients to help individuals who had injured joints or were suffering from arthritis. The devices, manufactured between 2004 and August 2021 by Exactech, however, are believed to be defective.
According to the U.S. Food and Drug Administration (FDA), the devices were likely exposed to oxidation due to defective packaging bags. The bags were reportedly missing an oxygen barrier layer that protected the devices from oxidation. The oxidation process can lead to the degradation of plastic. It is believed that the oxidation may have caused the inserts to wear faster, crack, or fracture.
Which Devices Were Subject to the Recall?
Exactech notes that multiple product lines were affected by the defective packaging bags. The knee and ankle polyethylene devices were sold between 2004 and 2021 with varying serial numbers. Connexion GXL and conventional hip liners were also recalled by the manufacturer.
Product lines affected by the recall include:
- OPTETRAK® All-polyethylene Tibial Components (TKR)
- OPTETRAK® All-polyethylene Tibial Components (PKR)
- OPTETRAK® Tibial Inserts (TKR)
- OPTETRAK® HI-FLEX® Polyethylene Tibial Inserts (TKR)
- ARTHROFOCUS® Polyethylene Tibial Inserts (TKR)
- OPTETRAK® Custom Polyethylene Tibial Inserts (TKR)
- OPTETRAK® LOGIC® Polyethylene Tibial Inserts (TKR)
- OPTETRAK® RBK® Polyethylene Tibial Inserts (TKR)
- TRULIANT® Tibial Inserts (TKR)
- OPTETRAK® Logic RBK Tibial Components (TKR)
- Vantage® Fixed-Bearing Polyethylene Liner Component (TAR)
- Vantage® Mobile-Bearing Polyethylene Liner Component (TAR)
- Acumatch GXL Acetabular Liners
- MCS GXL Acetabular Liners
- Novation GXL Acetabular Liners
- Exactech All Polyethylene Cemented Acetabular Cup
- Acumatch Conventional UHMWPE
- MCS Conventional UHMWPE
The failure of the devices, believed to be related to the defective packaging, put people at an increased risk for revision surgeries and bone loss. The harm to these individuals was extensive.
What Type of Harm Was Caused by the Exactech Devices?
Harm caused by the defective Exactech devices may include a number of problematic health conditions.
The Exactech joint replacement devices may cause:
- Pain and swelling
- Loss of mobility
- An inability to bear weight
- Weakness or the inability to walk
- A grinding noise near the device
- Bone loss
- Production of debris
- Damage of cartilage
Under certain circumstances, individuals with defective implants may have had to undergo revision surgeries to repair the damage and remove the implant.
Am I Entitled to Compensation?
If you suffered injury after having an Exactech ankle, hip, or knee implant that was subject to recall, you might be entitled to compensation. Depending on the situation, you may be eligible for compensation related to your medical bills, lost wages, and more. It is important to discuss your case with an attorney to determine your legal options.
How Much Does It Cost to Hire an Exactech Recall Lawyer?
Many people are hesitant to file a lawsuit based on a defective product because they fear it may be cost-prohibitive. Most cases, however, are accepted on a contingency fee basis, meaning that clients are not expected to pay attorney fees unless money is recovered on their behalf.
What to Do First If You Have a Defective Exactech Device Implanted
If you have a defective Exactech device implanted and have experienced pain, swelling, or other adverse effects, you need to speak with an attorney. It is important to keep all of your medical records related to your implant or any corrective treatment that you have had done since the initial surgery.
The more information you can provide to your attorney, the stronger your case will be. It is essential to seek medical attention immediately if you begin to experience worsening pain or discomfort at or near the implant site. Oxidation may have caused the insert to deteriorate or fail at a more rapid rate. Without treatment, the problem could become worse.
Contact Our Office to Learn More
If you had an Exactech knee, ankle, or hip device implanted, it may have been subjected to recall. Several Exactech product lines were shipped in defective packaging that allowed oxidation to occur. The oxidation may have caused the devices to crack, fracture, or fail completely.
If you suffered adverse reactions after having an Exactech joint replacement device installed, contact our office at (305) 402-9050 to schedule a free case evaluation.
