In December of 2016, DePuy Orthopaedics issued a Class II Recall for its elbow implant system, the DePuy Synthes Radial Head Prosthesis System. The recall indicates a potential for serious injury if the joint replacement implant fails and was issued due ta fault that could allow the device to loosen.
Patients affected by the defective device may experience:
- Pain and inflammation
- Loss of bone tissue
- Joint loosening
- Revision surgery
The elbow implant recall is not the only challenge the orthopedics company has faced. DePuy and its parent company Johnson & Johnson have been forced to issue numerous recalls and has faced thousands of lawsuits for other artificial joint replacement products including hip, knee and elbow devices.
DePuy Elbow Implant Complications
The DePuy Synthes elbow implants were the subject of dozens of serious adverse event reports filed with the U.S. Food and Drug Administration prior to the company’s recall decision in December 2016. By the date of the recall which included 50,311 unused Radial Head Prosthesis System elbow replacement devices, thousands of people already had the devices implanted.
The recall cited a concern that the radial stem may loosen but other problems could emerge as well. People who suffered device failure were subject to serious complications including:
- Device loosening
- Poor joint mechanics
- Osteolysis or bone dissolution
- New bone fractures
- Severe pain
- Soft tissue damage
When a joint replacement device like the DePuy elbow implants is defective and subject to failure, the patient is usually required to undergo revision surgery to remove and replace the device.
In some cases, patients will require multiple revision and reconstruction surgeries to repair or reconstruct damaged tissue. Each additional surgery poses added risk of pain, inflammation, infection and risk from anesthesia and will require a lengthy recovery period before maximum function is restored or achieved. In some cases, disability may be permanent.
Shortcut to DePuy Elbow Implant Approval
The U.S. Food and Drug Administration (FDA) is tasked with ensuring that medical products are safe to use when sold on the U.S. market. The medical device approval process has been circumvented by many companies who use a shortcut to approval known as the 510(k) process. The 510(k) application allows for companies to claim that a new medical device is similar to a device that has already been used in U.S. patients.
This claim of “substantially similar to” and “not different from” other devices has allowed companies like Johnson & Johnson’s DePuy unit to skip costly clinical testing. It also means that the DePuy Synthes Radial Head Prosthesis System was never tested as an elbow implant in U.S. patients. Some of the claims were made regarding other elbow implants, but some of the devices the Synthes elbow implant was reportedly “similar to” were not even elbow devices but were spinal or even dental implants.
This shortcut may have led to the early failure rates and eventual recall of all of the Synthes Radial Head devices.
Past Joint Implant Recalls
The DePuy elbow implant recall and pending lawsuits are not the first device implant failures for the orthopedics industry, or even the first for DePuy or parent company Johnson & Johnson.
In addition to the 2016 DePuy recall, the Stryker company had to recall 17,000 elbow replacement devices due to potential damage that occurred in shipping. Most recalls and lawsuits have however, focused on the knee and hip implant industry.
- Stryker Rejuvenate & ABG II Hip Stems – recalled in 2012 and subject to thousands of lawsuits. In 2014 Stryker agreed to pay $1.43 billion to settle many of the lawsuits but more may remain and have yet to be settled
- Johnson & Johnson/DePuy ASR Hip Implants – recalled in August of 2010 and subject to thousands of lawsuits. In 2013, J & J indicated it would pay about $2.5 billion to settle 8,000 lawsuits but more may have been filed and have not been settled.
- Johnson & Johnson/DePuy Pinnacle Hip Implants – have not been recalled but have caused complications similar to other models. Lawsuits and settlements are ongoing, with over 8,000 still yet to be resolved.
Other companies involved in hip and knee recalls, lawsuits and settlements include Zimmer Biomet, Smith & Nephew, Stryker, DePuy and Wright Medical.
DePuy Elbow Implant Lawsuits
DePuy elbow implants were used in thousands of elbow replacement surgeries and may have caused serious complications or required revision surgery for many of these patients. People or loved ones who received a DePuy Synthes Radial Head Prosthesis System and who experienced serious side effects or required revision surgery may be eligible for compensation for damages related their injuries and should seek legal advice.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.