A DePuy elbow implant lawsuit may be an option for patients who suffered serious complications associated with the devices. Medical devices such as hip and knee replacements, shoulder implants and elbow implants are designed to restore joint function and relieve pain and discomfort. However, Johnson & Johnson has issued a recall for its DePuy Synthes Radial Head Prosthesis Systems due to implant loosening at the radial stem, potentially leading to osteolysis, pain, bone fracture and soft tissue damage. Affected patients and their families may be able to file a lawsuit and recover compensation with the help of a defective medical device attorney.
If you or a loved one is experiencing problems with a DePuy Synthes radial head prosthesis, contact Attorney Group for information on your options. We offer free, confidential consultations, without any obligation on your part. If you choose to pursue a claim, we can connect you with an affiliated DePuy elbow implant lawsuit attorney who can assist you throughout the legal process.
Radial Head Fractures
According to Clinical Orthopaedics and Related Research, radial head fractures are common and account for roughly one-third of all elbow fractures. Signs and symptoms of a possible radial head fracture include:
- Pain (usually worse when turning the palm up and down)
Radial head fractures range in type and severity. Some fractures only need minimal treatment while complex radial head fractures may require surgery to repair bone fragments. In some cases, a prosthetic replacement may be used to stabilize the elbow and forearm.
What is the DePuy Synthes Radial Head Prosthesis System?
Medical devices such as hip and knee replacements, shoulder implants and elbow implants are designed to restore joint function and relieve pain and discomfort. The DePuy Synthes Radial Head Prosthesis System is intended for primary and revision joint replacement of the radial head, a portion of the outer forearm bone (radius) located at the elbow. The device is manufactured by Synthes Holding AG, a subsidiary of Johnson & Johnson.
The DePuy Synthes Radial Head Prothesis was approved under the U.S. Food and Drug Administration’s (FDA) 510(k) premarket notification process, a type of approval procedure in which the manufacturer must prove that their device is substantially equivalent to another legally marketed device.
DePuy Elbow Implant Risks
If the radial stem loosens after surgery, patients may be at risk of the following:
- Osteolysis (destruction, disappearance or reabsorption of bone tissue)
- Poor joint mechanics
- Post-operative bone fracture
- Soft tissue damage
Other potential complications related to elbow implants and replacements include infection, injuries to nerves and blood vessels, allergic reaction to the artificial implant, joint stiffness or instability, and weakness or failure in the tendons of the arm.
DePuy Synthes Radial Head Prosthesis Recall
According to a letter sent to physicians on December 30, 2016, Johnson & Johnson issued a medical device recall for its DePuy Synthes Radial Head Prosthesis System, stating:
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 fully characterize these factors. 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.
The Synthesis Radial Head Prosthesis is a two-piece modular system consisting of various sizes and lengths to fit the needs of the patient. Although the entire system is affected by the recall, only the radial stem has the possibility of loosening after surgery. Devices have reportedly been known to fail in as little as six months.
Health care professionals and doctors were advised to continue to treat patients in the usual manner and to look out for signs of loosening and other serious complications related to the elbow implants. According to the FDA’s Medical Device Recall Database, the cause is still under investigation.
How a DePuy Elbow Implant Lawsuit Can Help
Medical device makers have a duty to provide safe products. If there are risks of harm associated with their products, they also must provide adequate warnings. If a medical device maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
People injured by a defective DePuy elbow implant may be eligible to recover money for:
- Medical Expenses
- Lost Wages
- Pain and Suffering
The families of those who have died may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one with the help of a DePuy elbow implant lawsuit attorney.
For more information, contact Attorney Group. After you contact us, an attorney will follow up to answer questions that you might have. There is no cost or obligation to speak with us, and any information you provide will be kept confidential.
Please note that the law limits the time you have to pursue a claim or file a lawsuit for an injury. If you think you have a case, you should not delay taking action.