Exactech® Knee & Ankle Implant Recall Lawyers

Defective Medical Devices Increases Risk of Pain, Complications

Global medical device manufacturer Exactech® has recalled knee, hip, and ankle implants that increase a patient’s risk of severe pain, complications, and premature prosthetic failure.

In 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.” Almost 500,000 devices manufactured and shipped throughout the world since 2004 are part of the recall. Non-confirming knee and ankle were shipped and implanted by surgeons as recently as February 2022.

Recalled implants include the following brands:

• OPTETRAK®
  • All-Polyethylene CR Tibial Components
  • All-Polyethylene PS Tibial Components
  • CR Tibial Inserts
  • CR Slope Tibial Inserts
  • PS Tibial Inserts
  • Hi-Flex PS Tibial Inserts
• OPTETRAK Logic®
  • CR Tibial Inserts
  • CR Slope Tibial Inserts
  • CRC Tibial Inserts
  • PS Tibial Inserts
  • PSC Tibial Inserts
  • CC Tibial Inserts
• TRULIANT®
  • CR Tibial Inserts
  • CR Slope Tibial Inserts
  • CRC Tibial Inserts
  • PS Tibial Inserts
  • PSC Tibial Inserts
• VANTAGE®
  • Fixed-Bearing Liner Component

Call our firm at (888) 997-4110 right now if you have any questions about Exactech®lawsuits and if you can file one.

Knee & Ankle Replacements Vulnerable to Corrosion

In a letter sent to certain orthopedic surgeons, hospitals, and other health care professionals, Exactech® stated its knee and ankle replacement devices are prone to failure due to insufficient product packaging. Since 2004, out-of-specification or non-conforming vacuum bags were used to package the devices. The bags were not completely oxygen-proof due to a missing protective layer. As a result, the metal materials within the knee and ankle replacements could oxidize, corrode, and deteriorate before implantation, leading to rapid device failure once implanted.

The company is receiving additional fallout from not informing the general public and all patients who have or might have had a knee or ankle replacement device about the known issue. Instead, Exactech® informed only certain health care providers. This roundabout method of informing patients about a potentially severe health risk is unacceptable to today’s legal and medical standards.

Injuries Caused by Exactech® Knee & Ankle Device Failures

When a knee or ankle replacement device fails, it is not a simple matter that can be quickly dismissed. It is a serious situation that could lead to life-changing injuries and illnesses suffered by the patient.

When a recalled knee or ankle device fails, the patient can suffer from the following:

• Bone loss and bone density reduction
• Adjacent tissue and muscle damage
• Inability to stand or walk
• Severe, chronic pain in the affected joint

Symptoms that the device is failing include the following:

• Clicking in your knee, ankle, or hip
• Inability to bear weight
• Instability
• Noises such as grinding coming from the implant
• Pain while walking
• Swelling in the joint

The only way a doctor can confidently address and correct the situation is to recommend revision surgery to replace the defective device with something else. Revision surgery always carries its own risks of complications, and joint replacement surgery is always followed by a painful recovery. It is unfair that patients with Exactech® ankle and knee devices should have to go through another surgery because the company was not careful enough with its product packaging.

Hip Replacements Are Also at Risk

Exactech®’s Connexion GXL is not an official part of the recall, but the company warned that patients may experience problems with their hip replacement procedure using the device. According to the company, the GXL liner was transitioned out of the U.S. market entirely in 2021.

Between 2019 and 2021, Exactech® observed early linear and volumetric wear in Connexion GXL liners implanted in some patients between 3 and 6 years of their hip replacement surgery. The company notes that in “some of these patients, wear has led to proximal femoral and acetabular osteolysis.”

The Connexion GXL liners include the following:

• MCS Liners
• Novation Liners
• Acumatch Liners

How to Know If Your Implant Is Recalled

Your surgeon might proactively reach out to you if a recalled or faulty device was used in your implant procedure. If you do not, contact your doctor. If you have the implant’s serial number, you can look up whether you are impacted on the Exactech® website or by calling the company at (800) 912-0403.

Revision surgery is not recommended for patients whose implants are performing well.

Symptoms that the device is failing include the following:

• Clicking in your knee, ankle, or hip
• Inability to bear weight
• Instability
• Noises such as grinding coming from the implant
• Pain while walking
• Swelling in the joint

Compensation for Recalled Implant Devices

Holding Exactech® Accountable for Defective Implants

These medical devices are meant to safely and effectively replace a knee or ankle joint. But many patients are suffering serious health complications and injuries because of a now-identified product defect that causes the knee or ankle implant to fail, sometimes within as little as 60 days after surgical implantation.

Faraci Lange, LLP in Rochester is currently hearing from patients throughout New York and the country who have suffered due to a defective Exactech knee or ankle implant device. Depending on the outcome of ongoing investigations into the defect and whether it should have been reasonably prevented, the manufacturer could be fully liable for any damages and losses you have endured. We want to be the legal team that helps secure that compensation and sense of closure for you.

Do you have a valid claim to bring against Exactech® for its defective joint replacement devices? Find out by speaking with our attorneys today. We offer legal counsel and assistance to potential clients nationwide. If we hear from enough potential clients, then a class action lawsuit could potentially band a plaintiff class together for one strong case against the company.

Find out more by dialing (888) 997-4110 today. Remember: Initial consultations are FREE and confidential at our firm.