The Driscoll Firm, LLC, currently is investigating cases of fractures or loosening among patients who received the DePuy LPS Diaphyseal Sleeve in reconstructive knee surgery.

The U.S. Food and Drug Administration (FDA) has issued a Class I recall of this device – the most serious kind of recall – while the manufacturer is warning hospitals and surgeons to immediately stop using or distributing the product.

If you or a loved one has suffered any complications that you believe are linked to the DePuy LPS Diaphyseal Sleeve – or if you believe you face a risk of these complications – contact The Driscoll Firm, LLC, right away. Call our toll-free number or complete our online form for a free consultation. An experienced defective medical products lawyer from our firm can immediately begin to review your case as well as your options.

Why Was the DePuy LPS Diaphyseal Sleeve Recalled?

The Class I recalled issued by the FDA is the most serious type of recall. It applies only to situations in which there is a reasonable probability that using the product “will cause serious adverse health consequences or death.”

Why did the FDA make such a serious move?

According to the FDA, the DePuy LPS Diaphyseal Sleeve is to be used with the LPS System – an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects. The device is manufactured by DePuy Orthopaedics, Inc., which is a subsidiary of Johnson & Johnson. The FDA says the diaphyseal sleeve should enhance the fit and fill of the diaphyseal femoral canal with femoral and tibial replacements.

However, the FDA says, the sleeve-to-sleeve base taper connection may not be sufficient enough to accommodate potential physiologic loads during normal movements by some patients. In turn, the sleeve may fracture at the taper joint, possibly leading to a loss of function or loss of limb, infection, compromised soft tissue or – in the worst cases – death.

In a February 22, 2013 safety notice, the FDA said that it had received 10 reports of the device malfunctioning – six reports of fractures, four reports of loosening – which may be linked to the same design issue. Based on these reports, the FDA issued the Class I recall notice.

While a recall will keep future reconstructive knee surgery patients from the risk of harm that is possibly linked to the DePuy LPS Diaphyseal Sleeve, it may be too late for those experiencing symptoms. That’s why it’s important to seek immediate medical and legal attention in order to protect your health and your legal rights if you believe that you have received this implant.

Next Steps for DePuy LPS Diaphyseal Sleeve Patients

1. Get information about the recall.

According to the FDA, the recalled lots were manufactured between 2008 and July 20, 2012. The product codes are: 1987-20-018, -020, -024 and -028.

2. Contact your physician who may have used the recalled device.

The FDA says that the manufacturer, DePuy, sent an “Urgent Medical Device Recall” notice to hospitals and surgeons on January 4, 2013. DePuy said to immediately stop distributing or using the recalled lots.Although DePuy said that revision or follow-up would not be necessary if patients weren’t showing symptoms with the implanted device, it did encourage surgeons to communicate with patients about the risks and methods for detecting failure of the device.

Note: If you are not sure whether the recalled device was used in your surgery, The Driscoll Firm, LLC, can help you to track down this information.

3. Contact an attorney.

A legal claim arising from injuries sustained due to a defective medical product is called a product liability lawsuit. It’s important to move efficiently and effectively when dealing with such a claim by contacting a law firm that has experience in this often complex area of the law.

The Driscoll Firm, LLC, has a record of protecting the rights of defective medical device victims across the United States. We can investigate your case and explore all possible options. If you are entitled to compensation for injuries resulting from the DePuy LPS Diaphyseal Sleeve, we want to make sure you receive the full amount you deserve.

Compensation may include money for your pain and suffering, loss of enjoyment of life and the medical costs you have incurred, including past and future treatment and therapy.

To learn more, call us toll-free today or complete our online form. We can review your case for free and get started right away.

For more information:

• DePuy Orthopaedics LPS Diaphyseal Sleeve: Class I Recall – Taper Connection May Not Accommodate Physiologic Loads, U.S. Food and Drug Administration
• DePuy Orthopaedics, Inc – LPS Diaphyseal Sleeve, Recall Notice, U.S. Food and Drug Administration