DePuy Synthes Elbow Replacement

In 2011, the Food and Drug Administration (FDA) approved the DePuy Synthes Radial Head Prosthesis System, an elbow replacement device designed to replace the elbow joint. It helped patients restore function after an elbow injury or a progressive condition (like severe arthritis) affected their range of motion.

Unfortunately, DePuy recalled the Synthes elbow replacement system in 2016 because the radial stem can become loose after surgery. Problems with the replacement joint could cause severe complications, including pain, fractures and soft tissue damage. In some cases, people needed revision surgery to fix the issues caused by the joint loosening.

Because of these serious issues, some patients who received an elbow replacement using a DePuy Synthes device are suing Johnson & Johnson for damages.

How the Device Works and Why It Was Used

The DePuy Synthes was intended to replace the radial head, or the round end of the radius bone that’s near the elbow joint in your forearm. The device allows for replacement of the elbow joint when the radial head is damaged due to acute trauma or a condition such as severe arthritis that gets worse over time.

The radial head is more likely to suffer a fracture than other parts of the elbow joint. In situations when elbow trauma is too complex to respond to treatment using a cast or sling, removing and replacing the damaged radial head is often the recommended treatment. Severe elbow arthritis could also create a need for replacement.

When radial head replacement is necessary, a surgeon will remove the fractured bone and joint surface and replace it with an implant that includes a replacement for the radial head, with a stem that connects to the existing bone.

The DePuy Synthes provides the replacement head and stem. The system is modular, with 24 different heads and 10 stems, so surgeons can choose the implant combination necessary to restore the appropriate height and improve elbow stability. The device also has a side-loading assembly, which can simplify the surgical process by allowing for a smaller incision.

The FDA quickly approved the DePuy Synthes elbow replacement device with limited testing because it was substantially similar to other items on the market. Because the system had a range of different stem and head sizes, with differences in both length and diameter, Johnson & Johnson marketed the device as one that could accommodate many surgical needs.

Unfortunately, the DePuy Synthes elbow system did not do what was promised for many people who had elbow replacement surgery. The FDA’s Manufacturer and User Facility Device Experience (MAUDE) Database received hundreds of adverse event reports alleging that the DePuy Synthes resulted in problems, including:

Unfortunately, once the implant became loose and caused complications, many individuals needed revision surgery to correct the resulting health issues.

In response to the problems with the DePuy Synthes elbow replacement device, the FDA issued a Class II Recall.

The FDA describes Class II recalls as being appropriate in situations where “use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

In a 2016 notice announcing the recall, DePuy Synthes explained there were several possible reasons for device loosening. Because the company couldn’t identify the specific factors impacting the likelihood of this issue, it had to remove the device from the market.

In total, the manufacturer recalled 50,311 units, with the stated reason for the recall being “the possibility that the radial stem may loosen post-operatively at the stem bone interface.” Unfortunately, this recall came too late for many patients who already had elbow replacement surgery.

The FDA’s 510(k) Premarket Process

Not all FDA-approved products go through the in-depth testing you might expect. That’s because some products get expedited approval through the abbreviated 510(k) pathway.

The FDA can approve products more quickly and with less testing under the 510(k) clearance process if it deems them to be “substantially equivalent” to devices it has already approved. The FDA approved the DePuy Synthes devices under this pathway because they were very similar to several already-approved medical devices.

While Johnson & Johnson sold and marketed the DePuy Synthes elbow replacement system, the company was not involved in its design or testing. In fact, J&J acquired Synthes, Inc. — along with the rights to its medical device products like the Synthes Radial Head Prosthesis System — a year after the FDA approved the elbow replacement device.

After the acquisition, Johnson & Johnson marketed the Radial Head Prosthesis System and, through taking ownership of its manufacturer, became responsible for any harm resulting from the defective prosthetic.

If you have issues or concerns with a DePuy elbow implant, it is important to understand which symptoms can indicate device failure so you can get prompt medical help.

Because loosening doesn’t always cause health issues right away, some patients may need to undergo routine screening every six months to check for signs of problems.

If you received a DePuy Synthes elbow replacement and experience complications, you have legal and medical options.

Consult with a medical professional to determine if revision surgery is necessary. Get prompt medical help to check for signs of loosening if you begin experiencing symptoms. Always document any medical treatment you receive, as well as any diagnostic information provided to you, in case you decide to pursue a legal claim.

You may have a legal right to hold Johnson & Johnson responsible for complications resulting from this device. You should consult with an attorney about options, including filing a DePuy Synthes elbow replacement lawsuit for the damage you endured.