Exactech announced a medical device correction that expanded the prior limited recall of OPTETRAK Comprehensive Knee Systems in February 2022. The recall included all knee and ankle arthroplasty polyethylene inserts that were packaged in non-conforming vacuum bags, no matter the shelf life or label on the device.
Based on the information provided by Exactech, the purpose of the recall was because the inserts were put into vacuum bags that didn’t conform to the necessary specifications. The defect resulted in injuries to patients and the need for additional revision surgeries.
According to the FDA, this was considered a class II recall. What this means is that those exposed to the product may have medically reversible or temporary health consequences, or the potential for more serious health issues is minimal.
For individuals who received a total ankle or knee replacement starting in 2010 that included inserts or components made by Exactech, it is recommended that they contact their doctor to see if the device was used as part of the recall.
After a determination is made, you should contact our legal team to discuss what options you have.
Which Ankle and Knee Replacements Were Included in the Exactech Recall?
The following products were included in the Exactech recall:
- VANTAGE fixed-bearing liner component
- OPTETRAK all-polyethylene tibial components
- TRULIANT tibial inserts
- OPTETRAK Logic tibial inserts
- OPTETRAK tibial insets
Over 60,000 units of both OPTETRAK Logic and OPTETRAK components have been used in patients in the United States since 2004. There are also about 25,000 TRULIANT inserts used and another 1,500 VANTAGE fixed-bearing liner components in patients that were affected in the recall.
If you or someone in your family is unsure if they received one of the components included in the recall, it’s best to schedule an appointment or contact your doctor. They can look at the serial number and determine if your components were manufactured by the recalled Exactech parts.
Understanding Issues with Exactech Devices
The ankle and knee replacements made by Exactech are designed using different parts. Standard total knee replacement devices include four basic components, which include:
- The metal piece that will attach to your thigh bone is called the femoral component.
- A metal component that your doctor will fit into your shin bone, and is called the tibial tray.
- A plastic piece that fits on the kneecap is called the patellar component.
- The plastic insert that is fit between the femoral part and tibial component is called the tibial polyethylene insert. This is the part that serves as a new cushion for your new knee joint.
The standard total ankle replacement is designed using three parts, which include:
- The metal piece that attaches to your shinbone is called the tibial component.
- The metal piece that connects to the foot bone is called the talar component.
- The plastic insert that will fit in between the talar and tibial component serves as the cartilage or cushion to replace the ankle joint called the polyethylene insert.
Exactech discovered that one of the layers of packaging for the polyethylene insert that was used on both the total ankle and knee replacement didn’t meet specifications. It has also been found that the layer can let oxygen out of the air diffuse into the insert before it has been implanted in your ankle or knee. If too much oxygen spreads throughout the plastic insert while it is being stored, before implantation, it may cause oxidation. This will cause the part to wear out early and may even cause damage to the plastic once it is put in the body, which can cause an injury. If the plastic part is not used, there will be no cushioning to absorb the movement or impact that causes an injury or pain to the patient.
Symptoms That Your Exactech Ankle or Knee Replacement Is Failing
If you are concerned about the replacement you have in your body, you should speak to your doctor. However, there are some symptoms that will tell you there could be a problem, including:
- The inability to bear weight
- New or worsening ankle or knee swelling
- Pain when you walk
- Clicking on your ankle or knee
- Grinding or other sounds in the ankle or knee
- The inability to support your weight
Your doctor can examine you and provide you with more information about the replacement in your body.
Contact an Attorney to Help for Exactech Knee or Ankle Replacement Injuries
If there are issues with your total ankle or knee replacement, you have legal rights. Get in touch with our legal team to learn more about what options you have.