DePuy® Synthes Elbow Implant Lawsuit Information
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Patients who received the Synthes Radial Head elbow prosthesis were left with serious questions about the safety of the device and its impact on their health when a Class 2 recall was issued to pull the devices from the market. Those who suffered injury after being implanted with the device are seeking justice and significant compensation from the manufacturer.
50,311 Synthes Radial Head Elbow Prosthesis Pulled from the Shelves
The radial head elbow prosthesis can restore the functionality and movement to a joint damaged by trauma or degenerative disease. It may be used when you have trouble straightening, bending, or twisting the lower arm because of the elbow joint. The Synthes artificial elbow is comprised of a chromium and cobalt radial head and titanium alloy stem. The stem is inserted into the radius bone of the forearm, and the head is taper-locked to the stem.
The FDA issued a Class 2 recall for 50,311 of the elbow implants in 2016 after reports of stem loosening. When an implant loosens, the patients may suffer serious injury, including:
- Bone tissue damage
- Soft-tissue loss
- Poor movement and flexion
When an elbow implant device loosens, nearby bone and tissue may be damaged. It is important the implant is repaired or replaced, or it can continue to cause damage, pain, and poor functionality. If you had an elbow replaced with the Synthes Radial Head Prosthesis and suffered injury, you may be entitled to significant financial compensation.
Artificial Elbow Implant Procedures
If the head of the radius bone (found on the thumb side of the lower arm) is damaged from disease or trauma, you may lose critical functions such as being able to straighten the elbow out to reach for something or being able to bend the arm as you pick something up. You may also not be able to twist the forearm such as when you are turning a screw.
The Synthes elbow was approved by the FDA as a treatment for disease damaged elbows, as a replacement for previously implanted elbows, and as a treatment for traumatic injury. Traumatic injury to the head of the radius may occur more often than you think, and fractures are relatively common. In fact, 20 percent of acute elbow injuries involve fractures.
When you have an elbow replacement procedure, you can expect the surgery to take an hour or two, and you will probably have to remain in the hospital for several days. The surgery involves cutting through tendons and bone, so you may need to take pain medications for several weeks. Your doctor will explain your limitations, but you will typically not be allowed to lift more than a cup with that arm.
You will have to endure several weeks of physical therapy to strengthen the joint, increase flexibility, and improve range of motion. Still, your elbow will not typically be as strong as it was before the damage and you will have ongoing restrictions on your activities.
As trying as it can be to have an elbow replacement, if you were implanted with the artificial Synthes elbow, you may have been shocked to learn about the recall, or you may not have been surprised because you were already having issues. It’s important to know that if you were implanted with the recalled Synthes elbow and you suffered tissue and bone damage or had to have additional surgeries to fix or replace the stem, you have rights, including the right to seek generous compensation. Contact us now to learn more.
Synthes Stem Loosening
The radial head prosthesis was recalled in 2016 because the stem can loosen at the bone stem interface. But that wasn’t the first time the device was recalled. In 2013 the artificial elbow was recalled from the market in a Class 2 recall after reports of trial head loosening. The trial head is used during surgery before the permanent head is attached. Surgeons reported the head was loosening from the stem during the implantation procedure while the arm was being manipulated.
Typically, before a medical device is sold on the market, it must be rigorously clinically tested to prove its safety and efficacy. The FDA reviews this information before approving for use. The radial head artificial elbow implant was not approved through the usual process. It was approved through the controversial FDA 510(k) process, a program that greatly reduces the time it takes to get to market. The program allows a product to bypass clinical testing if it is substantially similar to a product that is already on the market.
If you suffered injury after being implanted with the recalled radial head elbow prosthesis, contact us today to learn if you are entitled to compensation for your injuries and losses.
Symptoms of Stem Loosening
The implant maker has not determined the cause of the defect, and it has not provided surgeons with instructions on mitigating loosening problems. It also has not provided information to implant recipients on the signs and symptoms of loosening they should be aware of.
Researchers examined elbow implant failures and determined that even when there is no other signs or symptoms, pain may indicate device loosening. In a study published in the Journal of Shoulder and Elbow Surgery, researchers suggest that when these prosthetics are implanted without cement, one of the first signs of loosening may be proximal radial arm pain.
Other symptoms of stem loosening may include swelling around the joint and range of motion issues such as problems twisting, bending, and extending your forearm. If you have any of these symptoms contact your physician right away. Then call us.
We Can Help
Patients who were implanted with a defective elbow prosthesis and suffered injury such as bone and tissue damage, pain, post-operative fracture, and risky revision surgery may be entitled to seek justice for their injuries and compensation from the device maker. If you were implanted with a recalled Synthes radial head artificial elbow, contact us today.
For decades we have fought for justice for people harmed by the medical devices they depend on to help and we will fight for you. Contact us today if you were implanted with the defective artificial elbow prosthesis and learn more about your rights by law, the recall, and whether you are eligible to seek generous compensation for your injuries and losses.
A Class 2 recall of 50,311 DePuy Synthes Radial Head Prosthesis in 2016 left patients who had already received the device not knowing what to expect. The key takeaways for patients with the Synthes artificial elbow are:
What’s the problem with the device?
There’s a problem with the stem loosening. The stem is the part of the device that is inserted in the radius bone of the arm. When it loosens, it may cause serious tissue and bone damage, cause severe pain, and it may not function properly. A loose implant must be fixed or replaced with a different device.
Already have the prosthesis?
Anyone who has one of these elbow prosthetics should be aware of the signs and symptoms of stem loosening. If you experience pain that radiates from the implant or down the arm, if you notice a decreased range of motion or hear noises from the joint, you should schedule an appointment with your physician, and have the elbow joint evaluated. If your elbow implant loosened or prematurely failed, contact us to learn more about the legal options that may be available to you, including your eligibility to seek compensation.
Don’t know if your implant was the one that was recalled?
It’s actually common for a patient not to know the make, model or brand of a medical device. That is not an issue for us. We can review your medical records and identify if the prosthetic you received was recalled. If your elbow implant was the recalled Synthes radial head implant and you have been suffering pain, or tissue and bone damage, or if you had to have more surgeries to fix the device or replace it, you may be entitled to seek justice and compensation for your injuries.
Do you have a lawsuit?
If you were implanted with the recalled elbow prosthesis and you suffered pain, bone loss, tissue damage or had to have revision surgery to replace or repair the implant, then you may be entitled to file a lawsuit seeking damages. Any person who is injured by a defective medical device has rights, including the right to justice for their injuries and losses.
What damages am I entitled to?
If you were implanted with a defective device, you may experience significant losses. The types of damages you may be entitled to include compensation for missing work, medical costs and expenses, and even for the pain you suffered. You shouldn’t have to pay for costs related to an injury you didn’t cause. Damages are awarded to make you whole again by compensating you for what you lost. Contact us today to learn more.