DePuy, a subsidiary of Johnson & Johnson, are the subjects of a massive knee replacement recall issued by the FDA on two of their artificial joint models: LPS™ Diaphyseal Sleeve and the LPS™ Lower Extremity Dovetail Intercalary Component. If you received one of the listed DePuy knee replacements listed and if you’ve experienced any side-effects you’ll read about in this article, contact a DePuy knee replacement lawyer to have your case evaluated.
What You Need to Know about the FDA’s Recall on DePuy Knee Replacements
Any company that makes something, regardless of whether it is a medical device, clothing, or even food you buy in the grocery store, can issue a recall on their own products if they believe that something might be wrong with it. That sort of recall is known as a voluntary recall. When the FDA issues a recall, it is because they’ve determined that the product (in this case) is too dangerous to be used how it was intended to use.
There are five different categories of recalls that may be issued by the FDA. DePuy knee replacements were the subject of a Class 1 recall. That is the most serious type of recall. It means that the FDA believes the use of these knee replacements can cause serious health problems or even death.
DePuy’s Longstanding Issues with the FDA
When a company wants to sell its medical devices to the public, they must first get the approval of the FDA. Most of the time, the devices must undergo substantial testing and studies and then gain the approval of the FDA. Sometimes, a company will update a device, but it isn’t a substantial change. In those instances, the device generally doesn’t undergo another round of laborious testing and studies. However, they still have to undergo a variation of the approval process.
DePuy faced an earlier recall, a Class 2, in 2009. The FDA’s recall stated that there was a crack on the lateral side of their Sigma Knee System. In 2010, the FDA sent a warning letter to DePuy and the matter was ultimately closed out in 2012. Between 2003 and 2013, almost 300 DePuy devices have been recalled. That’s more recalls than any other knee replacement manufacturer.
DePuy’s recalls included problems with assembling components (such as noted in the Class 2 recall in 2009 mentioned above), faulty seals, improperly labeled components, risk of the device fracturing, and sizing problems.
How DePuy Knee Replacements May Affect Your Health
You may be wondering how something that seems as small as a faulty seal or a crack in the device could really affect your health. The fact is that it can cause serious, long-term health problems. Common side-effects found in patients who received a faulty DePuy knee replacement that was recalled include:
- Serious joint infections.
- The need for future repair.
- Damage to surrounding soft tissue.
- Inability to use the knee and leg.
- Amputation due to infection.
- Death.
Did You Receive a DePuy Knee Replacement and Get Sick?
If you had a recalled DePuy knee replacement and suffered from serious side effects, contact Goldwater Law Firm right away to have your potential case evaluated by an experienced DePuy knee replacement attorney. You may be entitled to compensation for your medical care, lost wages, disability, and pain and suffering. Don’t wait. Call Goldwater Law Firm now or use our contact form and schedule your free case review right away.