Global medical device developer and manufacturer Exactech has recalled two of its signature products, expressing concern that certain product defects may lead to injury in transplant recipients. In July 2021, the company announced a recall for its Connexion GXL hip implants due to indications that the plastic in the liners of those devices was wearing out faster than anticipated. Around the same time, the company recalled all liners in its Vantage, Optetrak, and Truliant knee and ankle replacement implants, and advised medical professionals not to implant them.
When the U.S. Food and Drug Administration issued the recall on the Exactech Connexion GXL hip implant liners, it cited as its cause for concern that the liners as manufactured were subject to excessive wear caused by “edge loading.” Edge loading occurs when the design and/or manufacture of a device leads to excessive wear around the edges of the device. Data suggests that the Connexion GXL liners are subject to edge loading and excessive wear at the point where the femur, or thigh bone, connects to the implant. The excessive wear caused by the friction between the femur and the implant can result in degeneration of the femur bone, which in turn can cause the implant to loosen and lead to failure.
Problems with the knee inserts also involve the vacuum bags in which the implants were packaged. According to Exactech and the FDA, those bags did not meet specifications, causing increased exposure of the transplants to oxygen, which in turn leads to more rapid deterioration of the plastic. The potential consequences are similar to those with the knee implants—a disintegration of bone mass in the knee, a loosening of the knee implant, and ultimate failure of the device.
The recalls apply to all hip implants put in place after 2009 and all knee implants performed after 2004. The knee implants subject to recall include:
Hip implants recalled because of faulty or defective liners are thus far limited to the Connexion GXL product.
Common symptoms associated with the deterioration of the plastic in the hip and knee implants include:
If you have experienced any of the symptoms stated above, you should immediately schedule an appointment with your implant surgeon. Whether you’ve experienced symptoms or not, you should contact an experienced defective medical devices attorney, someone who knows how to handle these types of claims and who has successfully helped others in similar situations. You have a right to seek compensation for any financial losses caused by a dangerous or defective medical device, as well as any pain and suffering you may experience. To connect with a proven personal injury lawyer, fill out our contact form at the top right corner of this page.
... Read More
The Objectives of the Constitution | Finding Your Way Around the Constitution The primary original function of the U.S.... Read More
The Checks and Balances in Our System of Government After achieving independence from England in the Revolutionary War,... Read More
How It Works