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Smith & Nephew R3 Acetabular System Recalled
Smith & Nephew is a multinational medical equipment manufacturer based out of London, England, with products sold in over 90 countries, including the United States. They are the world’s fourth-largest producer of orthopedic reconstruction products, including the Smith & Nephew Birmingham Hip Resurfacing (BHR) System. Approved by the Food and Drug Administration in 2006, the BHR system is a metal-on-metal hip replacement system designed to relieve pain and improve hip joint function. The reality of this product is that is has proven to be dangerous, ineffective and harmful to patients.
The BHR consists of two parts:
- A cap in the form of a ball head known as the femoral resurfacing component
- A socket in the shape of a shallow cup known as the acetabular component
The acetabular component was designed to replace the damaged surface of the hip socket, while the femoral resurfacing component is inserted in to the top of the thigh bone. This system was created to work modularly, meaning that doctors would have multiple choices in terms of what parts to fit together in an individual patient. This design was supposed to help doctors cater to the individual needs of their patients and create a system that was right for them. The reality was that the BHR system used materials that were dangerous, defective, and caused higher than normal rates of revision surgery.
Recalled after 5 years
Just five years after the initial release of its BHR system, Smith & Nephew issued a recall of the metal liner used in its R3 Acetabular system. After the recall, the company issued a supposedly precautionary “hazard alert” to doctors that had prescribed this system to their patients. The problems in the BHR Acetabular system stem from the product’s metal-on-metal design.
When the metal liners of the individual components rubbed against each other during the course of normal use in patients, the motion would cause erosion of the metal lining. This erosion caused metal particles, including Cobalt and Chromium, to be released into the patient’s blood stream and surrounding tissues. These metal particles caused tissue and bone death around the surgically implanted hip, which lead to many complications including loosening of the hip joint and other device failures. The elevated concentration of Chromium and Cobalt in the bloodstream also created a medical condition known as Metallosis, which has many severe side effects including:
- Severe hip and leg pain
- Tissue and bone death
- Drastically reduced mobility in the hip
- Pseudotumors around the surgically repaired area
Between 2009 and 2012, it is estimated that nearly 4,000 BHR R3 Acetabular metal liners were used on patients in the U.S. These malfunctioning devices caused many patients to undergo dangerous and extremely painful revision surgery to undo the damage done by the Smith & Nephew BHR system.
When patients are forced to undergo painful and costly revision surgery following the implant of a medical device, the corporations responsible for manufacturing and marketing these defective products must be held accountable. If you or a loved one has been injured or required revision surgery following a Smith & Nephew BHR or R3 Acetabular system, you may be entitled to compensation for your pain and injuries.
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Call The Yost Legal Group today at 1-800-YOST-LAW (967-8529) to discuss the details of your case with an experienced Baltimore Medical Malpractice and Product Liability attorney for FREE. Our legal team will examine the details of your case and stand with you from the start of your claim through to the finish.
If you have been injured due to the negligence of a medical device manufacturer, time may be running out to file a claim for damages. Call the experienced Baltimore Medical Malpractice attorneys at The Yost Legal Group today, and we will help provide the answers you seek.