Because prosthesis implants can be effective, even miraculous, in helping people regain their mobility without pain and discomfort, thousands of patients have been implanted with knee and ankle replacement systems. However, hip, knee, and ankle implants have a history of severe problems and defects.
Meyers & Flowers has a team of Chicago product liability lawyers currently representing clients who have experienced injuries due to failure of their knee and ankle implants containing Exactech Knee and Ankle Ultra-High Molecular Weight Polyethylene, specifically:
- OPTETRAK®
- OPTETRAK Logic®
- TRULIANT® tibial inserts and components
- VANTAGE® fixed-bearing liner components
When did the Exactech recall begin?
Beginning in August of 2021, Exactech began recalling polyethylene liners for some of its knee and ankle implants. By February 2022, the company expanded its recall to include “all knee and ankle arthroplasty polyethylene inserts packaged in non-conforming bags regardless of label or shelf life.”
In June of 2021, Exactech issued a letter informing its purchasing doctors that the company was phasing out the polyethylene Exactech GXL Connexion liners used in its Novation, Acumatch, and MCS systems hip replacement products. However, this is not a recall, and the company will transition to its new XLE polyethylene liner infused with Vitamin E.
Why are Exactech hip, knee, and ankle implants being recalled?
It was not until 2022 that most consumers learned about the design issues when the FDA expanded the recalls. This prompted the FDA to implement several warnings and recalls for the potentially dangerous product, which affected nearly 150,000 patients. After receiving numerous reports of adverse effects associated with the defective systems, the FDA issued a Class II recall, meaning “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences.”
After extensively testing the clinical performance of the Exactech polyethylene inserts, it was confirmed that most of their total knee replacements and total ankle replacements with polyethylene components and inserts made after 2004 were packaged in defective vacuum bags. Products in this packaging could have been exposed to oxygen, which significantly degrades the liner. This makes the system prone to:
- Fracture
- Crack
- Other adverse effects occur earlier than expected, sometimes as early as one-year post-
- implantation
GXL hip liners also pose a risk for premature wear. While there is no Connexion GXL hip replacement recall, Exactech informed surgeons that under certain conditions, patients with hip replacements that use the GXL liner might be at risk for higher wear rates. This warning came after the company observed that.118% of patients who have had their implant for 3 to 6 years after initial surgery may have earlier wear on the liners.
- Exactech listed factors that may contribute to premature GXL liner wear, including:
- Larger femoral heads
- Higher patient activity levels
- Devices that were implanted by using a direct anterior hip surgery approach
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Which Exactech implants were recalled?
All three generations of the Exactech knee systems have had polyethylene inserts packaged in defective bags at various points while on the market. In response, Exactech recalled all Optetrak, Truliant, and Vantage brand knee and ankle replacement liners manufactured as early as 2004. The company advised surgeons not to implant defective products, and to return any conforming and nonconforming devices to Exactech.
- Recalled Exactech knee and ankle implants include:
- Optetrak All-Polyethylene CR Tibial Components
- Optetrak All-Polyethylene PS Tibial Components
- Optetrak CR Tibial Inserts
- Optetrak CR Slope Tibial Inserts
- Optetrak PS Tibial Inserts
- Optetrak Hi-Flex PS Tibial Inserts
- 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
How do I know if the Exactech recall affects me?
Symptoms of polyethylene wear are generally associated with bone loss or excessive particle debris released from the degraded liner. Some people may suffer bone loss, also called osteolysis, without symptoms. Contact your doctor to determine whether you need to monitor your implant for potential future issues, even if you don’t currently have any symptoms.
Exactech’s recall acknowledges that its products are defective and subject to high failure rates. Premature prosthesis wear of the Exactech knee and ankle polyethylene liners can lead to one or more types of injuries, including:
- New or worsening pain
- Inability to bear weight in the area
- Device loosening
- Grinding or other noises coming from the implant
- Recurrent swelling
- Infections
- Failure to bond to the bone
- Instability in the knee or ankle
- Component fatigue cracking or fracturing
- Tissue and nerve damage
- Osteolysis, or bone loss
- Metallosis or metal debris shed into the bloodstream
- Revision surgery
- Clicking in your knee, ankle, or hip
- Pain while walking
- Swelling in the joint
If you have a hip implant with a GXL liner, you should contact your surgeon — especially if you have symptoms. Exactech recommends doctors closely monitor patients with recalled inserts for potential osteolysis and excessive wearing by using X-rays to determine excessive wear or bone and tissue damage.
Some patients have contacted Exactech to be reimbursed for out-of-pocket costs, such as medical bills from doctor visits or potential surgery. Lawyers are currently investigating Exactech claims, and patients may choose to file Exactech replacement lawsuits in an attempt to be compensated for:
- Medical bills
- Lost wages
- Pain and suffering
- Other damages
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Why choose Meyers-Flowers for your defective Exactech device?
Filing a lawsuit against a major corporate entity such as the manufacturers of Exactech takes great effort and skill, mainly because they hire teams of corporate defense lawyers to manage claims and lawsuits. The result is a focus on protecting their client, not protecting the rights of injured patients. At Meyers & Flowers, we level the playing field and fight back for innocent consumers who have suffered injuries from defective medical devices.
If you have had a total knee or ankle replacement that failed, or if you are dealing with pain, inflammation, range-of-motion issues, or require/have undergone corrective revision surgery, seek legal representation to assist you in pursuing total financial compensation for damages. At Meyers & Flowers, our Chicago-based team of product liability lawyers can answer your questions and help you with a case against Exactech.
Contact us today for a free case evaluation online or by phone at (630) 232-6333. No fee unless we win or settle your case.
