DePuy Synthes Radial Head Prosthesis System is an elbow replacement prosthetic device that has been shown to become loose after surgery.
DePuy Synthes is a subsidiary of Johnson & Johnson. The company was granted clearance to manufacture the prosthetic from the Food and Drug Agency in 2011 under the agency’s 501(K) program.
What is the Radial Head Prosthesis System?
The Radial Head Prosthesis System (elbow replacement system) has two pieces used as a primary or revision joint of the radial head of the elbow. It is a modular system made of a cobalt chrome head and titanium alloy stem components. This is combined with its integral side-loading and screw application for in-situ assembly.
There are 24 heads and 10 stems that go along with this system. It allows surgeons a choice of 240 combinations to choose from for the elbow implant. The side loading component allows surgeons to make smaller incisions on the patient.
The Radial Head Prosthesis System may be used for:
- Restoring joint function with primary as well as revision joint replacement of the radial head of the elbow joint
- Replacing the radial head for post-traumatic or degenerative disabilities
- Primary replacement after the radial head has been fractured
- Symptomatic episodes after resection of the radial head
- Revision after unsuccessful arthroplasty of the radial head
DePuy’s Questionable Introduction onto the Market
DePuy’s elbow joint prosthetic did not undergo any trials prior to its release on the market. That’s because the 501(K) program allows a manufacturer to develop devices (or products) that are shown to be “sustainably equivalent” to similar products on the market, without requiring any human clinical trials.
A year after DePuy Synthes received its 501(K) approval, there was a merger between Johnson & Johnson and DePuy. In the 501(K) process, Synthes presented its elbow implant was substantially equivalent to 12 devices already on the market. It was compared to ten other types of Synthes medical products on the market such as dental implants or spinal fusion devices.
DePuy mentioned, quite clearly in its application for 501(K) approval, there were no safety or effectiveness issues with the new device in comparison to previous models. The company said its device shared indications for use, materials, and fundamental technological characteristics to other similar competitors. Such companies were Biomet ExploR Modular Head, Straumann Dental Implant System, Ascension Modular Head, and Titan Endoskeleton Interbody Fusion Devices.
Radial Head Recalls
In 2016, DePuy recalled over 50,000 of its prosthetic Radial Heads. The radial stem (which anchors the device to the radius bone of the arm) could become loose after surgery. When a loosening happens, the device does not function properly, and may cause other health issues such as pain, postoperative bone fracture, loss of bone tissue, and damage to soft tissues.
This recall prompted the US Food and Drug Administration to issue a Class II medical device recall in February 2017. This level classification happens when the product “may cause a temporary or reversible health problem or where there is a slight chance that it will cause serious health problems or death.” This device recall indicated there had been previous adverse reports about the DePuy Synthes Radial Head Prosthesis.
The FDA posts information about a correction or removal action in its Medical Device Recall Database. This is where updates, additional recalls, or terminations about the product will be made. This hub may also contain press releases, market withdrawals, safety alerts, or other public notices for consumers.
Upon the issue of the recall, DePuy instructed medical professionals to return the unused Radial Head as quickly as possible.
DePuy Synthes Radial Head Prosthesis Problems
The complications from the DePuy Radial Head Prosthesis vary from person to person. Determining if an implant will fail is very hard, but the first signs will typically occur with pain in the forearm.
In 2012, the Journal of Shoulder and Elbow surgery published an article that warned of the pain that may occur with a radial head replacement. This pain can sometimes be misinterpreted or attributed to typical pain post-surgery, and unfortunately there are no guidelines for diagnosis.
The study outlined that pain in the forearm is one of the first major indications of an adverse event. According to the authors of the study, proximal radial forearm pain is an indication of symptomatic mechanical loosening. Furthermore, some devices may have a textured surface that helps support ingrowths of the bone. If these types of units are implanted without cement, there is a strong likelihood there will be loosening, even without radiographic signs.
Symptoms of a loosened elbow replacement implant include:
- Impaired range of motion
Doctors will try to figure out the cause of the pain through certain tests, such as bone scans, x-rays, and other imaging.
The complications from the DePuy elbow implant include:
- Corrective, or revision, surgery due to complications resulting from the loosening of the elbow implant
- Symptomatic loosening implant that has not yet been resolved through surgery
- Osteolysis, or bone loss
- Impaired range of arm and joint motion/poor joint mechanics
- Fracture of the bone around the implant as a result of loosening
- Damage to or aggravation of soft tissue
When there is a device loosening, the only options to correct it are through revision surgery to replace or repair the device. The loosening is not only uncomfortable, but it can be a further inconvenience in terms of missing work or disrupting plans in order to have yet another surgery, and may cause an increased amount of medical bills.
A few years prior to the FDA recall, DePuy recalled 147 of its Radial Head Prosthesis Systems in February 2013 because of a problem with its trial head. The trial head is used during surgery to check if the actual head of the soon-to-be implanted device will fit and function correctly. The concern was the trial head (that comes with the system) was found to come loose from the stem during surgery.
Do you have a DePuy Synthes lawsuit?
Many people have had to undergo the terrible inconvenience of surgery or an increased amount of pain as the result of the defective DePuy Synthes Radial Head Prosthesis. If you or a loved one have suffered the same complications, you may be entitled to financial compensation by filing a lawsuit against the manufacturer. We offer a Free Case Evaluation and would be honored to speak with you.