Exactech Joint Replacement Recalls

Exactech is a manufacturer of joint replacements for individuals afflicted with arthritic conditions or injuries in their ankles, knees, hips, and shoulders. They have a solid reputation for producing high-performing medical devices, with a significant number of their joint replacement devices demonstrating strong success rates. Nonetheless, the company has recently faced issues with a number of joint replacement models.

These issues led to a substantial recall, as some of the Exactech hip, ankle, and knee replacements exhibited early degradation due to packaging flaws. The company also recalled several defective hip replacements. In total, from August 2021 onwards, approximately 200,000 models spanning knee, hip, and ankle replacements have been recalled due to premature device failure.

Recipients of these recalled devices experienced complications, leading to a revision surgery mandate to rectify problems such as implant loosening. These complications gave rise to a wave of litigation against Exactech. 

Several individuals who underwent revision surgery filed lawsuits. Consequently, in October 2022, a Judicial Panel combined over 75 lawsuits related to Exactech into a single action.

Exactech Hip Implants

As a major producer of joint replacement devices, Exactech fabricates primary hip implants along with systems and individual components designed specifically for revision surgery. The company’s array of medical devices includes models like Alteon, Novation, and BIOLOXdelta. Studies have demonstrated a relatively low likelihood of replacement for Exactech’s hip implants within a five-year time frame.

The medical journal Hip Arthroplasty published a study in 2022 revealing that the Novation replacement model showcased a commendable 92.4% survival rate at five years. 

However, not all components of Exactech hip implants have mirrored this high level of performance. For instance, the Connexion GXL polyethylene liners, a product of Exactech, have been associated with increased instances of bone loss surrounding the hip socket and thigh bone.

Although severe complications remain infrequent, they may necessitate revision hip surgery. Potential complications stemming from hip replacement can include:

• Swelling
• Pain
• Injury to blood vessels
• Fractures
• Stiffness
• Blood clots
• Dislocation
• Nerve damage
• Alteration in leg length
• Infection
• Loosening of the implant

In June 2021, Exactech announced a recall for their Connexion GXL acetabular polyethylene liner. This was a mandated corrective action due to premature wear of the prosthesis, which played a significant role in the early failure of hip replacements and the subsequent need for revision surgery.

Exactech Ankle Implants

The ankle replacements offered by Exactech are crafted for surgeons to carry out replacements on injured or arthritic ankles. Among their primary ankle replacement offerings are the Vantage PSI and Vantage Total Ankle System, engineered to mimic the natural structure of a human ankle. Studies have shown an impressive 95% success rate for the Vantage ankle system.

In 2021, Exactech recalled the polyethylene liner employed in their ankle replacements. This liner serves to simulate natural ankle cartilage, nestling between the tibial and talar components. The cause of this recall was problematic packaging leading to exposure to oxygen, which threatened the liner with potential degradation.

Those requiring revised ankle replacement surgery are patients experiencing loosening of the talar component. However, Exactech advises against revision surgery for those who have not encountered any issues or symptoms.

Exactech Knee Implants

Exactech knee implants are specialized medical devices designed for orthopedic surgeons to perform replacements on knees that have been damaged by arthritis or injury. Notable models comprise the Optetrak and Truliant series. Exactech boasts a remarkable success rate for these knee replacements, claiming a performance rating of 94% to 98% over 10 years.

However, a recall was initiated by Exactech in 2021 involving the ultra-high molecular weight polyethylene inserts utilized in their knee replacements. These inserts act as synthetic cartilage within the artificial joints. 

The issue arose from the packaging, specifically out-of-specification bags that permitted an elevated level of oxygen exposure to the inserts. Exactech indicated in a 2022 updated recall letter that this could precipitate degradation, potentially leading to premature implant failure.

Consequences of implant degradation could mean excessive wear and eventual failure, which would necessitate revision surgery. Corrective procedures for defective Exactech knee implants typically demand a longer operation time than the original replacement surgery and carry their own risks of complications. The patient must also endure another strenuous recovery process, along with physical therapy.

Was Your Exactech Implant Recalled?

In the event of a recall involving your Exactech knee, hip, or ankle replacement device, it’s very important to talk to your surgeon and discuss potential options. Diagnostic procedures such as X-rays may be employed by your surgeon to detect damage or premature wear to bones and surrounding tissues.

Patients who haven’t experienced implant issues are typically monitored by surgeons. Surgery won’t be suggested for those who are asymptomatic. Should any problems arise, talk to your surgeon about the potential pros and cons of revision surgery.

For reimbursement related to a recalled replacement device, you can contact Exactech directly. To manage the recall claims, the company commissioned the firm Broadspire to take on the responsibility of reimbursing out-of-pocket expenses.

If you have experienced complications and have a recalled device, you may be eligible to file a claim. Individuals who’ve had complications, like loosening of the implant, can file an Exactech lawsuit if surgery is likely or already completed. A personal injury lawyer can assist you in seeking compensation for your medical expenses, including pain and suffering, and lost wages.

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