A Florida-based medical-device manufacturer, Exactech® has recalled certain models of hip, knee and ankle replacement devices due to a myriad of potentially dangerous issues. The recall started in August of 2021 and related to the devices failing or breaking down prematurely.
The U.S. Food and Drug Administration (FDA) identified several models of Exactech joint replacements made with polyethylene inserts that were not properly packaged. The packaging of the products consisted of vacuum bags that lacked a second barrier layer with ethylene vinyl alcohol (EVOH), which helps to provide oxygen resistance.
Over time, exposure to excess oxygen can cause the implant material to wear down, potentially break and fail prematurely inside the patient.
These issues can lead to serious health complications, including bone loss, pain and the need for revision surgery to repair, remove or replace the defective device.
Millions of Americans are living with hip, knee and ankle replacements. As these devices age and fail, many will be at risk for complications as a result of a defective Exactech device. Because Exactech did not directly warn patients about the implant problems, many patients are only learning about potential implant defects after experiencing adverse symptoms and complications.
The Dangers of Exactech Implant Devices
When an Exactech implant breaks down, it can cause the device to loosen or fail, leading to potentially severe physical symptoms, mental anguish and costly medical care. Problems may include:
- Premature device failure
- New or worsening pain
- Bone fractures
- Clicking, grinding or popping in the joint
- Inability to bear weight
- Instability in the affected joint
- Bone degeneration (Osteolysis)
- In many cases, revisionary surgery is needed to replace the defective device.
Exactech Product Models Included in the Recall
If you are suffering issues relating to one of the recalled devices listed below, you may be eligible to pursue compensation.
Ankle & Knee Replacement Recalled Devices
- 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
- Optetrak HI-FLEX PS Tibial Inserts
- Optetrak “MOMB” Non-Mod Molded Insert
- Optetrak RBK PS Tibial Components
Exactech 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 CR Tibial Inserts
- Truliant CR Slope Tibial Inserts
- Truliant CRC Tibial Inserts
- Truliant PS Tibial Inserts
- Truliant PSC Tibial Inserts
- Vantage Fixed-Bearing Liner Component
The recalled Exactech Connexion GXL liners can be found in the following hip replacement systems:
- Exactech Acumatch®
- Exactech MCS®
- Exactech Novation®
What to Do If You’ve Experienced Symptoms
If you or a loved one has an Exactech hip, knee or ankle replacement device and is experiencing adverse side effects, it’s important to speak with your doctor right away. Your doctor will be able to diagnose any complications and advise you on whether replacement surgery may be required. If you do not know if you have one of the recalled devices, ask your physician or obtain your medical records. The surgical record should contain a list of all implanted devices.
You may be eligible to file an Exactech lawsuit if you:
- Have a recalled Exactech ankle, knee or hip replacement device
- Suffered pain or injuries relating to the Exactech implant
- Have had revisionary surgery or have been told you need revision surgery
If you have suffered harmful effects from a defective hip, knee or ankle Exactech implant, the attorneys at Lacy Katzen LLP may be able to help. The attorneys at Lacy Katzen LLP have proudly represented injured individuals and their families for over 70 years. Please contact Jacqueline M. Thomas for a free consultation.