In conjunction with the Food and Drug Administration (FDA), medical device provider Exactech has issued a recall of certain knee, hip, and ankle replacement products due to a packaging problem that increases the odds of the device failing and health complications occurring. The recall is classified as a Class II recall, meaning that its continued use could cause “temporary or medically reversible adverse health consequences.”
If you had one of the defective devices implanted and are concerned about your health, an Exactech lawyer from the Law Offices of Michael J. Gopin, PLLC can help. We established our firm in 1987, and ever since then, we have worked tirelessly to protect the rights of injured victims. Contact us for a free case review to discuss your options for financial recovery.
Summary of Replacement Recalls
The problem stems from the way the medical devices were packaged and stored. They are packaged in vacuum-sealed bags to protect them from oxygen. If oxygen permeates through the bags, this can lead to oxidation that degrades the polyethylene material and lead to excessive wear. The company discovered that many of the products were packaged in out-of-specification bags that exposed them to oxygen. As a result, some of the devices were warped before being implanted in patients.
The company issued a letter in February 2022 to notify doctors of the problem and the potential need for them to follow up with their patients. While the manufacturer only began the recall process in 2021, they discovered that the problem dates back to 2004.
According to the company, most of their replacement inserts manufactured since 2004 were packaged in out-of-specification vacuum bags that do not contain a secondary barrier layer that contains ethylene-vinyl alcohol that would further protect the devices with oxygen resistance. Due to this error, the parts are wearing at a higher rate than expected, with some severely degraded due to oxygen exposure.
Some of the problematic implants include:
- Exactech knee replacement – Consumers have reported problems with the plastic inserts in the affected Optetrak, Optetrak Logic, and Truliant Exactech knee replacement products. According to the company, these products were transported in non-conforming packaging that allowed oxygen to infiltrate the vacuum-sealed bags and warp them. This can cause the device to wear faster than expected and potentially fail.
- Exactech ankle replacement – Exactech’s ankle replacement products have a similar problem: they were packaged in vacuum-sealed bags that failed to protect the devices from early exposure to oxygen.
- Exactech hip replacement – Independent researchers have found that the Exactech Connecxion GXL liner used in hip replacement implants are linked to severe polyethylene wear, occurring on average within five years of the patient’s surgery.
Which Devices Were Recalled?
Exactech has recalled more than 147,000 defective knee and ankle replacement devices that were manufactured since 2004, including the following:
- Optetrak – Nearly 61,000 defective devices implanted
- Optetrak Logic – Nearly 61,000 defective devices implanted
- Truliant – Nearly 25,000 defective devices implanted
- Vantage – Nearly 1,600 defective devices implanted
If you had any of these devices implanted, it is possible the device is defective and could have been exposed to oxygen prior to your procedure. If you’re not certain you had one of these devices implanted, contact the medical provider who completed your procedure.
What Injuries Can Result from the Knee, Hip, or Ankle Exactech Replacement Recall?
If you had a defective Exactech knee or ankle device implanted in you, the replacement can fail. This can cause knee or ankle ligaments and cartilage to grind up against each other. This can cause the devices to degrade more quickly and cause the patient to experience injuries such as:
- Accelerated knee wear
- Debris production
- Bone loss
- Component fatigue cracking or fracture
- Ligament or cartilage damage
- Loss of mobility
What To Do If You Have a Recalled Exactech Hip, Ankle, or Knee Replacement
If you have had one of these replacement inserts implanted, you should consult with your surgeon. Your doctor can identify whether the specific device used in the surgery was part of the recent recall. Your doctor can then evaluate any symptoms you are experiencing and determine whether you should undergo revision surgery. However, there are risks with any surgery, so you should carefully evaluate your options.
Having one of the defective parts implanted significantly heightens the risk of future knee replacement problems. While Exactech has committed to issuing refunds to customers who have a defective device, they have not volunteered to pay for the related surgical expenses to remove the device.
You can contact an Exactech lawyer in El Paso to learn about your options to hold the company responsible for the harm you have suffered and your increased medical expenses.
How Can a Lawyer for Knee Replacement Help?
Product liability lawyers bring legal claims against manufacturers who produce defective items. Medical devices are a special category of defective products because they are surgically implanted in patients. They are more difficult to remove, and the financial costs associated with an additional procedure can be substantial. Additionally, the procedure can place someone who already has a medical condition that required the initial implant at additional risk. Furthermore, patients may experience pain and discomfort after a procedure intended to improve their medical condition.
Product liability attorneys understand these unique challenges and can help to fight to protect their clients’ rights. They can pursue compensation from the manufacturer or their insurance company and account for the full extent of your damages, including increased medical expenses, lost wages, and pain and suffering. If the defendant fails to offer a reasonable settlement for your claim, a lawyer can evaluate whether filing an Exactech lawsuit can help you recover fair compensation for the harm you’ve suffered.
Contact Michael J. Gopin Today for Help with Your Exactech Case
Patients place significant trust in medical device manufacturers to create effective products that do not endanger their health. When negligent manufacturers do not take the proper precautions to ensure their products are safe, patients can suffer as a result. The Law Offices of Michael J. Gopin, PLLC can help you hold negligent device manufacturers accountable for the injuries their products cause. We have over 30 years of combined legal experience we will leverage to help you understand your rights and to pursue fair compensation on your behalf. Contact us for a free case consultation.