DePuy Synthes Elbow Defect Prompts National Recall

Any patient who received the defective DePuy Synthes Radial Head artificial elbow implant may qualify for significant financial compensation. In fact, Depuy elbow implant lawsuit litigation continues to grow as patients are forced to endure pain, dysfunction, limited movement, and additional surgeries to fix or replace the device.

Elbow Implant Loosening

Thousands of elbow implants were removed from shelves across the country after reports that the implanted stem of the device could become loose after being implanted. The device stem is inserted into the top of the radius bone of the forearm, and the head is connected with a taper-lock mechanism. When the stem loosens, it can cause local tissue and bone damage, pain, and problems with the strength and movement of the arm.

More than 50,000 devices were recalled after a defect was found that causes the artificial joint to loosen. If you were one of the patients who was implanted with the elbow replacement before the recall was issued, you should be aware of the signs of loosening.

You may feel pain radiating through your forearm, and the joint may pop or make noise when you move and turn your arm. You may not be able to move the arm normally and have trouble straightening and bending the joint or turning the arm as if you were turning a screw. Should you experience any or all of these signs, you should make an appointment with your doctor as soon as possible so your implant can be evaluated. If your doctor finds that the stem has become loose, you may want to contact an attorney who is very experienced in defective product litigation to find out if what legal options may be available to you and your family.

Past Device Issues

Unfortunately, the elbow replacement device has been recalled before because of defects. A Class 2 recall was issued in 2013 because of loosening issues. Instead of the device coming loose post-operatively, surgeons were having issues during implantation. They reported having problems keeping the trial head attached to the stem while the arm was being manipulated during surgical implantation. The trial head is used during surgery before the chromium and cobalt head is attached.

Typically, before a medical device can be used, it may go through rigorous testing and clinical studies. The results of these tests and studies are shared with the FDA before the government agency approves its use. Unfortunately, the Synthes Radial Head artificial elbow did not have to undergo the same types of testing and studies because it was approved through a program that is considered controversial by most. The program, called the 510(k) premarket approval process lets manufacturers put products on the market without the same high-quality testing required for other devices if the device is significantly like a device that has already received FDA approval and is being sold on the market.

Patients who received the defective elbow implant and then experienced range of motion issues, pain, bone loss and tissue damage and had to have additional surgeries to fix or replace the device may be entitled to recover significant damages.

Speak to An Attorney

If you had to have additional surgeries to repair or replace your Synthes radial head artificial elbow, a deeply experienced and highly skilled attorney would be able to tell you more about patient rights, the defective device and if you are entitled to generous compensation.