Hip Implant Recalls and How They Work
When a company learns that there is a problem with one of its medical devices, they have a responsibility to alert consumers. The company will propose a correction or removal depending on the type of situation. When the manufacturer does so, the FDA refers to this action as a “recall.” Medical devices are recalled when they are a risk to a consumer’s health, are defective, or both.
Recalling Medical Devices
In some cases, a company (manufacturer, distributor, or other responsible parties) voluntarily recalls a medical device. When a company learns that its product violates FDA regulations, it initiates a recall (through correction or removal) and then notifies the FDA. The FDA is also allowed to demand the recall of a medical device.
The FDA will review the company’s proposed strategy, assess the health hazard, and determine whether the issue violates FDA law or requirements. If it does so, it will assign the recall a classification (I, II, or III) -I being the most serious, in order to indicate the relative degree of risk that defective product poses to someone.
The FDA will post about it in the Medical Device Recall Database as well as in the weekly Enforcement Report in order to notify the public. Once the violation has been remedied and the health hazard has been fixed, the FDA can then terminate the recall.
Metal on Metal Hip Replacement Recall
Parts of the Smith & Nephew Birmingham Hip Resurfacing and R3 Acetabular System were recalled in 2012 when the metal liner used in the hip was found to be defective. Like the Birmingham Hip Resurfacing System, the R3 System failed at a higher-than-normal rate—forcing hundreds of patients to undergo revision surgery.
Each year hundreds of thousands of patients undergo hip replacement surgery. Many of these devices have been recalled due to unsafe product defects and side effects, including releasing metallic ions into the patient’s bloodstream and causing Metallosis. Other problems include loosening of the implant, a squeaky hip, joint dislocation, and severe pain.
The Yost Legal Group is Here to Help
If you or a loved one has suffered from the harmful side effects of metal hip implant products, the defective hip attorneys at the Yost Legal Group can investigate your case and help you obtain the justice you deserve. For a free consultation, please call us at 1-800-YOST-LAW.