Before we talk about Exactech liners and defective packaging, we need to talk about oxygen. Oxygen is necessary for human life, but it’s a fairly reactive chemical element. We don’t think of oxygen as damaging but it can be very reactive. A perfect example of how reactive oxygen can be is fire. Get most things hot enough and they’ll start to react with the oxygen in the air and oxidize rapidly. In other words, they’ll start to burn.
This reactivity many things have to oxygen is one of the major reasons why there’s a recall for Exactech’s hip, knee and ankle implants. No, they don’t catch on fire, but they may have been exposed to too much oxygen before implantation. This could lead to premature wear, damage to bones and the implant breaking while inside the body.
How did the implants come into contact with too much oxygen? It appears to be the result of faulty packaging. Let’s take a closer look at what was wrong with the packaging and why that has allegedly led to problems with the Exactech implants.
Why Can’t the Implants Get Exposed to Oxygen?
When we worry about something getting too much oxygen, we’re usually referring to a situation where someone or something gets exposed to more oxygen than is typically found in the air we breathe. In most environments, oxygen makes up 21% of the air. But in the case of Exactech’s implants, even the 21% oxygen found in the air was enough to cause problems.
Many ankle, knee and hip implants from Exactech and other manufacturers are made from ultra-high molecular weight polyethylene (UHMWPE). This is a popular material for joint replacement because it has good resistance to mechanical wear and doesn’t react much with the human body.
One reason why UHMWPE is so durable is because it has special bonds and links between its molecules. But these special bonds and links can react with oxygen. This reaction then reduces the bonds and links that give UHMWPE its strength and durability. This can lead to the material becoming much weaker and creating tiny bits of debris around the joint.
To counter this problem, artificial joint manufacturers have special methods for packaging UHMWPE implants. First, they place them in special vacuum bags that have little to no oxygen inside them. Second, they use special materials for these vacuum bags, such as ethylene vinyl alcohol (EVOH). The EVOH helps keep air from leaking through the vacuum bags and exposing the implant to oxygen.
How Was Exactech’s Packaging Defective?
According to Exactech, many of its implants made from UHMWPE were not packaged with vacuum bags that contained EVOH. This meant that before the ultra-high molecular weight polyethylene implants were placed inside a patient, they were potentially exposed to oxygen, became damaged, and didn’t have the mechanical properties they should have had.
If you think you may have received an Exactech liner implant that could have been affected by the defective packaging, contact your doctor. Your doctor can check to see how your artificial joint is performing and help you confirm if there’s a problem. Depending on what they find, they can advise you on what you should do next concerning your physical health.
If it turns out you have a defective implant due to improper packaging, then you should think about calling a lawyer to learn more about your legal options. If you know of an attorney that can help you through this process, great. If not, feel free to give me a call at 919.546.8788 and I’ll see how I can assist.
Note: This article is not legal or medical advice. The article was written after review of news articles, company press releases, and FDA reports. Images are for illustrative purposes only.