The U.S. Food and Drug Administration is reminding patients and health care providers about the risks of previously recalled Exactech joint replacement devices.
Exactech issued a voluntary recall of knee, ankle and hip devices in 2022 and 2021. The recall was because of defective packaging that failed to protect the devices from oxidation.
According to Exactech, most of its devices were made with a polyethylene plastic insert. The packaging used to store the devices was missing a crucial component, allowing oxygen to reach the insert. Oxidation can cause device wear or failure, or component cracking or fracture, which can lead to revision surgery, according to the FDA.
Impacted devices were manufactured between 2004 and August 2021, and could have been implanted as late as February 2022.
At least 200,000 Exactech knee, hip and ankle devices have been recalled since 2021. The FDA advises health care providers to discontinue implanting the recalled products and to monitor patients with implants involved in the recall.
Recommendations for Patients With Exactech Devices
Exactech devices have been surgically implanted in nearly 143,000 patients since 2004. That means thousands of Americans could experience complications due to the defective packaging.
“Exactech joint replacement devices are used to replace painful, arthritic joints due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and loss of normal structure and function in adults,” according to the FDA statement.
The FDA also said, “These devices are also used to improve previously failed joint replacement devices [where] adequate bone and soft tissue are present.”
Patients who have a well-functioning device and are not suffering any issues, pain or symptoms should not seek a replacement.
People with the implants who are showing the following symptoms should contact a doctor:
- Grinding or other noises
- Inability to bear weight
- Instability
- New or worsening pain or swelling
- Weakness around the implant
Patients with ankle or knee replacements can cross-reference Exactech’s online database to see if their implant is part of the recall. Patients will need their device serial number to search the database.
Recalled Exactech Hip, Knee and Ankle Devices
The following Exactech products have been recalled:
Knee/Ankle Devices
- OPTETRAK All-polyethylene Tibial Components (TKR)
- OPTETRAK All-polyethylene Tibial Components (PKR)
- OPTETRAK Tibial Inserts (TKR)
- OPTETRAK HI-FLEX Polyethylene Tibial Inserts (TKR)
- ARTHROFOCUS Polyethylene Tibial Inserts (TKR)
- OPTETRAK Custom Polyethylene Tibial Inserts (TKR)
- OPTETRAK LOGIC Polyethylene Tibial Inserts (TKR)
- OPTETRAK RBK Polyethylene Tibial Inserts (TKR)
- TRULIANT Tibial Inserts (TKR)
- OPTETRAK Logic RBK Tibial Components (TKR)
- Vantage Fixed-Bearing Polyethylene Liner Component (TAR)
- Vantage Mobile-Bearing Polyethylene Liner Component (TAR)
Hip Devices
- Acumatch GXL Acetabular Liners
- MCS GXL Acetabular Liners
- Novation GXL Acetabular Liners
- Exactech All Polyethylene Cemented Acetabular Cup
- Acumatch Conventional UHMWPE
- MCS Conventional UHMWPE
Consumers have filed Exactech replacement lawsuits seeking compensation for injuries, medical bills, lost future income and lost wages, as well as pain and suffering. In some cases, a spouse may claim loss of companionship.
As of October 2022, there were 75 pending cases. Lawyers are still accepting clients and lawsuits have not yet been settled.