Beginning in 2021, Exactech began recalling polyethylene knee and ankle replacement liners that were manufactured after 2004. These replacement systems were packaged in non-conforming vacuum bags that may cause the liners and inserts to degrade early and fail, resulting in pain, bone loss, and revision surgery. According to the recall notice from Exactech, surgeons across the United States have implanted 147,732 of the affected devices in patients.
If you or a loved one have received an Exactech knee or ankle replacement after 2004, you may be affected by this recall. While Exactech is offering to address any out-of-pocket expenses, you may be eligible to file a lawsuit for additional compensation. Shapiro Legal Group, PLLC can help. Call today for a free and confidential case evaluation. We can help you understand your medical records, find out if your implant is affected by the recall, and explain your legal options.
Why Did Exactech Initiate the Recall?
According to communications from Exactech, the recall was initiated after extensive testing confirmed that most of it’s total knee replacements, partial knee replacements, and total ankle replacements were packaged in vacuum bags that were ‘non-conforming’. In this case, the bags did not have a secondary barrier layer containing ethylene vinyl alcohol that greatly increases oxygen resistance. This has led to increased rates of oxidation and breakdown of the liners. As a result, they have removed all affected products from the field and from hospital inventories and they will no longer be used.
What does this mean for patients who have already received these joint replacements?
Patients who have already been implanted with any of the affected devices may be at a much higher risk of complications such as:
- A significantly higher and earlier than expected rate of revision surgery.
- Increased risk of wear and failure of liners and other plastic parts.
- Development of bone loss (osteolysis)
- Loosening of the joint replacement
- Significant pain and swelling as a result
- Device fracture or complete mechanical failure of the device.
If you have an Exactech knee or ankle replacement and are experiencing pain, swelling, or any other complication, you may need to have revision surgery to replace the device. Currently, Exactech does not recommend that surgeons remove implants in patients that are not experiencing complications. However, due to the nature of the issue, many of those patients are more likely to develop problems and more likely to develop them sooner than expected. As a result, it may be in your best interests to speak with an attorney about the issue, whether you are currently experiencing complications or not.
What Exactech Knee and Ankle Replacement Systems Have Been Recalled?
In August 2021, Exactech initiated a recall of certain knee and ankle replacement liners. In February 2022, this recall expanded to all knee and hip replacement liners manufactured in or after 2004.
Exactech Partial Knee Replacement Systems – 680 affected devices
OPTETRAK®
- OPTETRAK® Unicondylar Tibial Components
Exactech Total Knee Replacement Systems – 145,491 affected devices
OPTETRAK®
- OPTETRAK® All-polyethylene CR Tibial Components
- OPTETRAK® All-polyethylene PS Tibial Components
- OPTETRAK® B-Series Ps Tibial Insert
- OPTETRAK® CC Tibial Inserts
- OPTETRAK® CR Tibial Inserts
- OPTETRAK® CR Slope Tibial Inserts
- OPTETRAK® PS Tibial Inserts
- CUSTOM OPTETRAK® Angled PS Insert
- CUSTOM OPTETRAK® CC Tibial Insert
- OPTETRAK® HI-FLEX® PS Tibial Inserts
- OPTETRAK “MOMB” Non-Mod Molded Insert
- OPTETRAK® RBK PS Tibial Components
OPTETRAK Logic®
- OPTETRAK Logic® CR Tibial Inserts
- OPTETRAK Logic® CR Slope Tibial Inserts
- OPTETRAK Logic® CRC Tibial Inserts
- OPTETRAK Logic® PS Tibial Inserts
- OPTETRAK Logic® PSC Tibial Inserts
- OPTETRAK Logic® CC Tibial Inserts
TRULIANT®
- TRULIANT® CR Tibial Inserts
- TRULIANT® CR Slope Tibial Inserts
- TRULIANT® CRC Tibial Inserts
- TRULIANT® PS Tibial Inserts
- TRULIANT® PSC Tibial Inserts
Exactech total Ankle Replacement Systems – 1,561 affected devices
VANTAGE®
- VANTAGE® Fixed-Bearing Liner Component
What Should Patients Do?
Anyone who has had a partial knee replacement, total knee replacement, or ankle replacement in or after 2004 should check to see if their device was affected by the recall. Check to see if you have documentation that lists your device’s manufacturer and serial number. If you do not have access to that information, contact your healthcare provider to find it. If it was an Exactech device, the company has a website that allows you to enter the serial number and check to see if your device was affected by the recall.
As previously mentioned, it is in all patients’ best interest to speak with a qualified attorney if they have been implanted with a recalled device. While Exactech is currently offering to address out-of-pocket expenses associated with replacing a failing or defective device, you will have other losses that you are entitled to compensation for. This can include”
- Pain and suffering
- Diminished quality of life
- Lost wages or diminished earning capacity
- Additional medical expenses
- and more
Additionally, if you are not currently experiencing complications, you still may be at a higher risk of developing them. An attorney can help you fully understand your options, and protect your claim and your health both now and in the future.
At Shapiro Legal Group, PLLC, we have been helping those injured or affected by dangerous drugs and medical devices for over 20 years. We understand how to successfully resolve defective medical device cases and have recovered millions of dollars on behalf of our clients. We handle all cases on a contingency fee basis and offer a no-cost, no-obligation consultation for all potential clients. If you or a loved one have received an Exactech knee or hip replacement, please contact our firm today.