DePuy Synthes Elbow Implant System

DePuy Synthes Elbow Implant System Lawsuit

When the DePuy Synthes Radial Head Prosthesis System was first introduced in 2013, it was touted as a superior system that could help restore joint function in all types of patients. However, just three years later, DePuy recalled tens of thousands of its prosthesis systems after patients experienced loosening of the device that led to severe complications.

Although lawsuits against DePuy are still in their early stages, lawyers from across the country are expecting countless victims of complications associated with the elbow implant to come forward. Lawsuits may include allegations that DePuy knew the implants were defective, failed to warn patients of risks, and more.

Find out more about the problems with the elbow implant systems and how victims may be eligible for compensation.

What is the DePuy Synthes Radial Head Prosthesis System?

The Radial Head Prosthesis System is designed for primary and revision replacement of the radial head. The radial head is the part of the radius bone closest to the elbow. By replacing the radial head, the prosthesis is meant to restore the joint function of the elbow.

According to DePuy Synthes¹, the system is indicated for the replacement of the radial head for degenerative or post-traumatic disabilities. It is also indicated for the replacement of a radial head after fracture, revision following failed arthroplasty, and symptomatic episodes after radial head resection.

This device is aimed at those who have fractured the radial head in a way that cannot be healed. The American Academy of Orthopaedic Surgeons estimates radial head fractures occur in about 20 percent of all acute elbow injuries².

Others may need the system after complications from an earlier surgery, such as infection or allergic reaction to a prior implant.

Background of the DePuy Synthes Elbow Implant

DePuy Synthes, a subsidiary of Johnson & Johnson, first announced the Radial Head Prosthesis System in December 2013. At the time, it was called a comprehensive solution with several benefits over other implant technologies.

“This system is a comprehensive solution for the radial head replacement that permits the surgeon to choose whether a long or short stem is best for the proximal radius,” Harry Hoyen of Department of Orthopedic Surgery at the MetroHealth Medical Center said in a press release at the time³.

The modularity of the system allows for customization. There are 240 possible implant combinations to enable surgeons to find the best fit.

Although touted as a new technology, the Radial Head Prosthesis System was approved by the U.S. Food and Drug Administration through the regulatory agency’s 510(k) approval process in 2011. To qualify for this type of approval process, a device simply has to be “substantially equivalent” to another device that’s already on the market.

By going this route, DePuy was able to forego clinical trials and testing that would typically be required for a new product. In its application, DePuy proposed that the prosthesis has the same indications for use, same fundamental technologies, and similar materials as two other radial head devices on the market⁴.

Based on that information, DePuy argued that the “proposed Synthes Radial Head Prosthesis System does not raise any new issues of safety and effectiveness in comparison to the predicate devices.”

The FDA agreed with DePuy and approved the application.

DePuy Synthes Elbow Recall Issued in 2016

Almost exactly three years after the system debuted, DePuy issued a recall of all lots of Radial Head Prosthesis System over evidence that the radial stem could come loose.

Although the entire system was recalled, only the radial stem had the possibility of loosening at the stem bone interface post-operation. In the urgent safety notification letter sent in December 2016, DePuy said it could not pinpoint the exact cause but believed the issue to be multifaceted⁵.

“Based on the currently available data, we believe the cause to be multifactorial (including possible product characteristics, operative, and patient factors), but we have not been able to characterize these factors fully,” the letter said. “Consequently, we have not been able at this time to issue further instructions to surgeons that might lead to a reduction in issue rate and have decided to remove the DePuy Synthes Radial Head Prosthesis Stem from the global market.”

According to the Class 2 Recall announcement from the FDA, a total of 50,311 units were recalled⁶.

Complications with DePuy Synthes Elbow Implant

A loosening of the radial stem can cause several severe issues in patients implanted with the DePuy Radial Head Prosthesis. Johnson & Johnson warned that it could cause the entire device to loosen, osteolysis, pain, limited joint mechanics, bone fracture, pain, and soft tissue damage.

While all systems were recalled, not all of the stems implanted have loosened. Identifying when a stem has loosened is difficult. One of the best indicators of loosening is pain.

According to a 2012 study in the Journal of Shoulder and Elbow Surgery, “reliable guidelines for diagnosing a symptomatic loose radial head prosthesis are lacking.⁷” However, pain in the center of the radial forearm can be an indicator of mechanical loosening.

As a result of the recall, surgeons were urged to follow patients with the implants in the usual manner.

Past Examples of DePuy Synthes Recalls

This isn’t the first time DePuy has issued a recall over its medical devices. In late 2017, DePuy issued a recall of an element of the Sigma partial knee replacement over elevated revision rates observed in post-market surveillance.

That was just the latest recall related to knee implants from DePuy. Other recalls took place in 2013, 2009, 2008, and 2001. Recalls have also been issued pertaining to DePuy hip replacement devices, including the ASR Acetabular hip replacement and Pinnacle hip implants.

Some of these recalls have resulted in thousands of lawsuits from patients affected by faulty devices. Nearly 20,000 people filed lawsuits against DePuy just over its ASR and Pinnacle hip implants with trial verdicts and settlements reaching more than $6 billion.

Attorneys Expect DePuy Elbow Implant Lawsuits

While the lawsuits against DePuy over the recalled radial stems are still in their early stages, lawyers expect countless people to come forward with claims against the medical device company.

The FDA received dozens of reports of device loosening related to the DePuy Radial Head Prosthesis in the years before the recall, including some that required revision surgery to correct. Revision surgery often carries its own complications and risks, which is why those who undergo a corrective surgery file lawsuits against the company who made the product.

Patients who have suffered unnecessary complications, such as revision surgery, and pain, may claim that DePuy Synthes knew of the risks but failed to notify the public. Other claims may involve allegations that DePuy designed and manufactured a defective device or downplayed the risks.

Why Patients Might File a Lawsuit

Those affected by unnecessary complications associated with the elbow implant devices may file lawsuits against DePuy to receive compensation.

For example, a settlement or verdict could cover medical expenses associated with revision surgeries, follow-up visits, physical therapy, and hospital stays. Injured patients may also be eligible to receive compensation for pain and suffering or loss of income due to complications.

On top of the financial awards from a favorable verdict, a lawsuit can also hold large companies who make defective products accountable for endangering patients in pursuit of profits.

Those who have suffered from stem loosening from DePuy Synthes elbow implants are encouraged to contact a qualified attorney immediately to talk about next steps in the legal process.

References

Synthes USA. “Radial Head Prosthesis System”, DePuy Synthes, http://synthes.vo.llnwd.net/o16/LLNWMB8/US%20Mobile/Synthes%20North%20America/Product%20Support%20Materials/Technique%20Guides/DSUSTRM10161137_RadialHeadProsthesis_TG_150dpi.pdf. Accessed September 18, 2018.
American Academy of Orthopaedic Surgeons. “Radial Head Fractures of the Elbow”, Othroinfo, https://orthoinfo.aaos.org/en/diseases—conditions/radial-head-fractures-of-the-elbow. Accessed September 18, 2018.
Kassy McGourty. “DePuy Synthes Trauma Launches Radial Head Prosthesis System in the U.S.”, Johnson & Johnson, https://www.jnj.com/media-center/press-releases/depuy-synthes-trauma-launches-radial-head-prosthesis-system-in-the-us. Accessed September 18, 2018.
Angela F. Lassandro. “510(k) Summary – Synthes Radial Head Prosthesis System”, AccessData – FDA, https://www.accessdata.fda.gov/cdrh_docs/pdf11/K112030.pdf. Accessed September 18, 2018.
DePuy Synthes. “URGENT NOTICE: MEDICAL DEVICE FIELD SAFETY NOTIFICATION”, DePuy Synthes, https://www.bfarm.de/SharedDocs/Kundeninfos/EN/11/2017/00202-17_Kundeninfo_en.pdf?__blob=publicationFile&v=1. Accessed September 18, 2018.
FDA. “Class 2 Device Recall Synthes Radial Head Prosthesis System”, FDA, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=152471. Accessed September 18, 2018.
O’Driscoll SW, Herald JA. “Forearm pain associated with loose radial head prostheses.”, National Center for Biotechnology Information, https://www.ncbi.nlm.nih.gov/pubmed/21856175. Accessed September 18, 2018.

DePuy Synthes Elbow Implant System Lawsuit