Patients who suffered injury after being implanted with the DePuy Synthes Radial Head elbow prosthesis system may be entitled to generous financial compensation. The artificial elbow was recalled from the U.S. market after it was determined an unknown defect could allow the device stem to loosen, leaving patients with concerns about premature failures and additional surgeries.
Recall Alert: 50,311 Synthes Radial Head Elbow Prosthesis Pulled from the Shelves
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The Synthes artificial elbow is used to restore movement and functionality when you are having trouble bending, straightening, and twisting the lower arm because of a traumatic injury or because of a damaging disease such as osteoarthritis.
The prosthesis is made of two main pieces: a titanium stem and a cobalt and chromium radial head. The stem is implanted into the radial arm bone, and the head is attached to the stem by a taper lock. In 2016, the FDA issued a Class 2 recall and pulled 50,311 radial head elbow implants from the market after it discovered the stem could loosen. Serious injury could be caused by a loosened stem, 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.
Elbow Replacement Procedures
The artificial elbow by DePuy was designed to improve the functionality of the joint when the head of the radius arm bone (the bone on the thumb-side of the forearm) is damaged from an injury or disease. It is also approved for use in patients who are having revision surgery for a previous implant. Fracture of the radial head is a relatively common injury, and nearly 20 percent of acute elbow injuries involve these types of fractures.
The procedure to replace the elbow can take up to two hours, and you may be required to remain in the hospital for up to four days. Because the surgery involves cutting through tendons and bone, you will need pain medication for a couple of weeks. Your activities will be restricted for four to six weeks, starting with lifting nothing heavier than your coffee cup.
You will have to complete weeks of physical therapy and range of motion exercises to get the joint as strong and flexible as possible. Your elbow probably won’t be the same as it was before the injury or damage, and you may be restricted from certain activities such as lifting heavy objects, hammering, and doing things that put a strain on the joint.
If you have to endure an elbow replacement you know that isn’t easy, though the payoff is typically worth it. However, patients who received the Synthes artificial elbow were shocked when they found out the device had been recalled from the market because of defect that could cause serious injury.
If you were implanted with the DePuy Synthes Radial Head elbow prosthesis and it loosened and caused you to suffer pain, tissue and bone damage, or required that you have additional surgeries to replace or repair the implant, you have right, including the right to seek justice and generous compensation for your injuries. Contact us now to learn more.
About the Elbow Replacement Device
The artificial elbow is implanted to restore as close to normal functionality to the elbow as possible after the joint is damaged by trauma or disease if other treatments fail to work, and in revision surgeries to replace an implant.
Whereas most medical devices must go through rigorous clinical testing before it can be sold on the U.S. market, the Synthes elbow implant was approved through the controversial FDA 510(k) process. This program streamlines the process and allows a product to enter the market quickly without clinical testing if that product is substantially similar to a product that has already been approved.
In 2013, the implant was pulled from the market in a Class 2 recall after issues with the trial head loosening. The trial head, the head used for sizing before the permanent head is affixed, was coming loose during surgery as surgeons manipulated the arm.
Three years later, the elbow prosthesis was recalled again for loosening problems that could cause patients to suffer serious injury. If you were implanted with the radial head elbow prosthesis, contact us now to learn more about the defect, your rights, and if you are eligible to seek justice and compensation.
Symptoms of Elbow Implant Loosening
One of the problems with implant loosening is that you may not know it’s happening until something bad happens. In fact, because the manufacturer was unable to determine what’s causing the defect, they are not able to instruct physicians on how to mitigate the problem. Nor did the device maker instruct patients on what they should do and signs and symptoms they need to be aware of. Unfortunately, you may not know your device is loosening until it starts hurting you. Not surprising, researchers have determined that one of the first symptoms of implant loosening is pain.
Researchers examined elbow implant failures and determined that even when there is no other signs or symptoms, pain may indicate device loosening. If you are suffering from proximal radial arm pain and your prosthesis was implanted without cement, your implant device may be loosening, according to a study in the Journal of Shoulder and Elbow Surgery. If you have localized swelling or trouble turning or extending and distending your elbow within the normal range of motion, your implant may be loosening, and you should see your physician as soon as possible.
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.
We have fought for the rights of people harmed by the medical device they need to help for decades, and we stand ready to fight for you now. 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.
Interview with the Attorney
When a Class 2 recall was initialized in 2016 for 50,311 DePuy Synthes Radial Head Prosthesis, patients who had already been implanted with the artificial elbow were left with little recourse. Here, we discuss the medical device, the issues, and the options that may be available to patients who have the recalled elbow.
Question: What’s the problem with the device?
Attorney Pulaski: The implant can loosen at the stem. The stem is inserted into the radius arm bone, and the head is then attached to the stem. When it loosens, it can cause damage to bone and tissue and cause severe pain. The device may not function properly, it may break, and will need to be repaired or replaced with a different implant.
Question: Is there a defect in the device head?
Attorney Pulaski: No, the cobalt and chromium head is not involved in the 2016 recall. The manufacturer reported the issue was with the stem loosening at the bone.
Question: What can patients who already have the device do?
Attorney Pulaski: If a person with one of these implants feels pain, notices a decrease in functionality, or hears noises from the joint, they need to let their doctor know so the implant can be evaluated. If the device has loosened or failed, they can call us to learn more about their legal options.
Question: How does a patient know if their elbow implant is the one that was recalled?
Attorney Pulaski: It pretty common for a patient not to know the make and model of an implant. It’s not a problem. If they have an elbow implant that has loosened or caused serious injuries, they can call us, and we can find out if the device is involved in the recall and what they can do.
Question: How does a patient know if they can file a lawsuit over a defective elbow implant injury?
Attorney Pulaski: If you’ve suffered injury from a defective product or medical device, you need to talk to an attorney as soon as you can. An attorney can help them determine if they are entitled to seek compensation for their losses.
Question: What types of losses are you talking about?
Attorney Pulaski: If you have a defective implant, you may incur medical expenses, may have to miss work, you may need to find transportation to and from your appointments, you may even need help to do your normal activities of daily life. These are the financial damages you may have sustained because of the injury. The law says you can seek compensation for those damages from the manufacturer of the defective product.
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