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A Class 2 recall was issued for the DePuy Synthes Radial Head elbow replacement device after a defect was discovered that allows the device to loosen at the stem. People who were already implanted with the device when it was recalled were left with concerns regarding safety, longevity, and how a defective device might impact their health. Patients who have experienced issues and injuries may be eligible to seek significant financial redress through a Depuy elbow implant lawsuit.
Over 50 Thousand Elbow Implants Pulled from Shelves
Generally, the radial head elbow implant is used to restore movement and functionality to the joint after it has been damaged by trauma or a degenerative disease which results in limited ability to straighten, bend, or turn the arm. To correct movement and function, the Synthes elbow may be implanted. It consists of a titanium alloy stem which is implant into the radius bone, and a cobalt and chromium radial head that is secured to the stem via taper-lock.
The Class 2 recall was issued by the FDA for all 50,311 devices on the market because of loosening issues. The FDA issues a Class 2 recall when there is a threat that use of the product could result in temporary health problems or when it poses even a slight threat of serious injury.
When an elbow replacement device loosens at the stem, you may suffer a serious injury such as:
- Bone tissue damage
- Poor movement and flexion
- Soft-tissue loss
When an implant device loosens, it is very important the patients seek medical advice and treatment. A loosened implant must be repaired or replaced or it may continue to cause damage to nearby bone and tissue. Patients who were forced to undergo additional surgeries due to premature loosening of their elbow implants may qualify for significant compensation for their injuries.
Symptoms of Stem Loosening
Unfortunately, when the recall was issued, DePuy was continuing to investigate the defect to determine the cause. Meanwhile, the company failed to give surgeons any instruction on how to mitigate the loosening issue and failed to give patients information regarding the signs of loosening. To learn more, scientists analyzed elbow replacement device failures and found that pain might be an indicator of a loosening problem, even if no other symptoms are present. Researchers also suggest that pain in the radius arm bone may be one of the first symptoms of loosening when elbow devices are implanted without being cemented in.
If you were implanted with the Synthes elbow replacement device, you should be aware that other indicators of the elbow stem loosening include joint swelling, problems with bending, turning, or extending the arm. Talk to your doctor as soon as possible if you experience any of these symptoms, then talk to an attorney about protecting your rights.
Protect Your Rights and Seek Justice
Any patient who was implanted with a defective DePuy Synthes Radial Head elbow replacement device and suffered post-operative fractures, tissue and bone damage, and had to endure additional surgeries to fix or replace the device may be eligible for compensation. Speak to an experienced defective implant attorney to learn more about protecting your rights and seeking justice and compensation for the damages you have suffered.