In August 2021, medical device manufacturer Exactech® recalled thousands of its knee and ankle replacement devices. The U.S. Food and Drug Administration (FDA) found that the devices, made with polyethylene inserts, may have been packaged in a way that exposed the inserts to too much oxygen. This caused them to degrade prematurely in patients' bodies, leading to serious health risks and revision surgery.
Exactech has now confirmed in a letter to surgeons that about 80% of nearly 150,000 knee and ankle replacement devices implanted in the U.S. were shipped in defective packaging. Exactech announced it has expanded the recall, which also included certain hip-implant components with similar issues.
This means that potentially thousands of Americans could suffer complications from Exactech products. However, Exactech hasn't directly warned patients who have knee, ankle, or hip replacement devices, and many patients are only learning about potential defects after experiencing symptoms.
Raising awareness of this growing issue is critical. Read on for important information about what to do if you or someone you know was implanted with a recalled Exactech device.
The Devastating Impact of Exactech Hip, Knee, and Ankle Implants
When Exactech implants fail, they loosen, leading to symptoms so painful that revision surgery is necessary to repair or replace the faulty product.
Affected patients are experiencing:
- Grinding, popping, or other noise
- Recurring dislocations
- Instability in the knee, ankle, or hip
- Inability to bear weight
- New or worsening pain
- Bone fractures
- Osteolysis (or bone degeneration)
- Infection and associated symptoms such as swelling and fever
These injuries can be debilitating and life-changing. The pain and instability can make everyday tasks difficult to manage. Infection can be a particularly severe complication in joint replacements, since antibiotics cannot access the bacteria, making surgery necessary instead.
Revision surgery is an invasive and complex procedure that:
- Can cost thousands of dollars
- Comes with risks, including but not limited to infection, damage to nerves or blood vessels, aggravation of prior medical conditions, and death
- Requires prolonged operating times and advanced surgical techniques to be successful
- Requires months of recovery, including costly physical therapy
- Leads to persistent pain in up to 20% of patients, in some cases lasting several years
This is the knock-on effect of potentially any of Exactech's recalled products. Included in the recall are certain Optetrak®, Optetrak Logic®, Truliant®, and Vantage® products made by Exactech, as well as Connexion GXL liners in Exactech hip implant products. The recall now covers all knee and ankle inserts packaged in defective bags "regardless of label or shelf life."
See this page for a full list of recalled Exactech knee, ankle and hip replacement products.
What To Do if You Are Impacted
If your or a loved one's device has been recalled, it would be wise to contact your doctor for an evaluation, particularly if you are experiencing pain, instability, or other complications.
In addition, if you or a loved one have suffered serious complications or have been told you need revision surgery, find out if you are eligible to file a lawsuit against Exactech.
Our defective medical implant attorneys have secured over $1.5 Billion for clients affected by faulty medical devices and dangerous drugs.
You can learn how to file an Exactech lawsuit here and Sokolove Law may be able to help.