DePuy Synthes Elbow Lawsuit

Understanding the DePuy Synthes Radial Head Prosthesis System

The DePuy Synthes Radial Head Prosthesis System was launched in December 2013. The purpose of the DePuy Synthes radial head plate was to provide surgeons with more options when it comes to restoring elbow joint function. This occurs by replacing the radial head of the elbow joint with a prosthesis. DePuy Synthes elbow plates are intended to be especially useful for those with radial head fractures too severe to repair, although the device was marketed to anyone with degenerative or post-traumatic disabilities due to joint damage.

DePuy sought — and received — expedited approval from the Food and Drug Administration (FDA). This means the company was allowed to market the device without first undergoing thorough trials and testing to ensure safety. This expedited approval process could have played a role in the eventual recall of these devices.

The issue with this prosthesis system is that the radial stem, which is the part of the device that connects directly to the radial bone, can become loose after the procedure is completed. Loosening is problematic for a number of reasons, as it can lead to bone-on-bone friction, tissue damage, and even infections.

Why Was This System Taken Off the Market?

The reports of problems with the DePuy Synthes Radial Head Prosthesis System came not long after the product was rushed to market. From 2014 through 2016, numerous reports were made to the FDA that DePuy Synthes Radial Head Prosthesis Systems were loosening within patients. This loosening resulted in damage to bone, severe pain, and other issues that could only be addressed through revision surgery.

The loosening issues were linked to one specific area of the device: the stem. However, in 2016, DePuy initiated a recall of every unit of this prosthesis system. In total, more than 50,000 units were recalled. This broad recall occurred after DePuy — a subsidiary of Johnson & Johnson — was unable to come up with additional instructions for surgeons to ensure the device could be installed safely.

While DePuy ultimately took action, it came nearly two years after the first reports of defects were made to the FDA. This delay resulted in thousands of patients facing painful side effects that could have been avoided. This failure to act quickly is one of the grounds cited in most DePuy Synthes elbow lawsuits.

Symptoms of Defective Prosthesis Systems

One of the challenging aspects of living with these defective systems is that problems are not always easy to detect. In fact, many of the symptoms of implant loosening might not be obviously related to your prosthesis. Understanding these symptoms is important for anyone considering legal action.

One of the primary symptoms to be aware of in these cases is pain. While this pain is in the area of the surgery, the problem is that it can be difficult to distinguish from the type of pain that is common following an invasive procedure. While some people believe they are hurting because their arm is healing, the reality in many cases is that the pain stems from a defective device. Pain is only one of the symptoms associated with this type of device failure. Some other potential symptoms include:

• Elbow swelling
• Limited joint mobility
• Bone loss
• Fractures in the bone near the implant
• Soft tissue damage

The failure to diagnose these symptoms in a timely manner can result in serious, long-lasting health consequences. For some people, the damage caused by defective prosthetic elbow joints cannot be undone by revisions or corrective surgery.

The Potential for Legal Action

If you are living with the symptoms described above after having the DePuy elbow implant procedure, you could have a viable case for monetary compensation. To qualify, you must meet two specific conditions:

• You took part in a DePuy elbow implant procedure during or after December 2013, and
• You required corrective surgery to fix the defective implant

If you meet these conditions, you could have a viable case for compensation. This involves a type of legal action known as a product liability lawsuit. Unlike most personal injury cases that are based on negligence, you could recover damages without proving that the manufacturer was directly negligent in your case.

When pursuing this type of case, you could be entitled to a wide range of financial compensation. For starters, this could involve the cost of medical care that resulted from the defective procedure. You could recover the cost of additional surgical procedures needed to address the defect.

Your other financial costs could also make up a big part of your case. For example, you could be entitled to recover damages based on any income you lost during the course of your recovery.

Finally, you could also be entitled to recover damages for your non-economic losses. This could include any hardship you sustained that is not directly measurable in dollars and cents, including your emotional distress or pain and suffering.

Talk to an Attorney About a DePuy Synthes Elbow Lawsuit

Many of the lawsuits related to the DePuy Synthes implant are in the early stages. If you or someone you love suffered pain or other symptoms after using this prosthetic, financial compensation could be available.

The team at the Gomez Law Firm is ready to help you seek justice for your pain. The manufacturer of this defective device should face accountability for allowing something so dangerous to enter the public marketplace. If you are ready to discuss your legal options, contact us right away for a free consultation.