ABOUT THE DEVICE
Hip replacements — the surgical repair of an aged or injured natural hip joint by adding an artificial joint or implant — date back three centuries.
Patients who have undergone hip replacement surgery may experience problems shortly following the surgery or years down the road.Reasons for these implants are the same now as they were then: a fracture or similar injury to the hip, arthritis or a wearing down of the joint over time.
Although there are varied designs and models of hips built by several manufacturers, there are three basic components of an artificial hip — a stem that is inserted into the femur (thighbone); a ball that attaches to the top of the femur; and a cup that attaches to the pelvis.
Modern implants, increasingly popular since the 1970s, are made from a combination of materials, including plastics, ceramics and metals. Many of the most recent devices were metal-on-metal designs, created with the hope that hip replacements would last longer to give younger, active patients more pain-free mobility for more years.
PURPOSE OF THE DEVICE
Depending on the age of the patient and the nature of the injury or condition, there are various surgical procedures to consider with the ultimate goal of reducing pain and increasing mobility. The three hip replacement procedures are total hip replacement, partial hip replacement and hip resurfacing.
Metal-on-metal hip systems are classified as Class III (higher risk) devices but are regulated under the Food and Drug Administration (FDA) 510(k) premarket notification program. That means they are not required to undergo premarket testing or clinical trials before they are used in patients. Under the 510(k) program, manufacturers simply have to state that their products are similar to products already on the market.
In May 2011, the FDA ordered 21 manufacturers of metal-on-metal products to conduct postmarket studies. A year later, an FDA panel found that there is little reason for surgeons to continue to use metal-on-metal implant systems.
Patients who have undergone hip replacement surgery may experience problems shortly following the surgery or years down the road. In most cases, complications stem from the materials used in the implants themselves. Metal-on-metal implants can lead to metallosis, which is a serious condition that occurs when metallic debris builds up in the soft tissue of the body. Osteolysis, another serious complication that can occur following hip replacement surgery, is the loss of bone around the implant as the body works to “clean up” foreign particles that are produced by the device during normal movement. This can lead to loosening and failure of the implant.
HOW BRAMZON & ASSOCIATES SPECIALTY LITIGATION LLC CAN HELP
As with any surgery, complications can arise that will have the potential to create long-term difficulties for patients. Patients have made legal claims against some of the most popular hip implant manufacturers, including DePuy, Stryker and Zimmer. Since the complications can vary substantially from patient to patient and the impact it has on someone’s life, plaintiffs are mostly concerned with their ongoing medical care needs as well as any future surgeries that may be required.
“Hip implant manufacturers behaved recklessly and have set aside billions of dollars to help those who may have suffered, to help them regain some semblance of peace and a comfortable life again,”
“Hip implant manufacturers behaved recklessly and have set aside billions of dollars to help those who may have suffered, to help them regain some semblance of peace and a comfortable life again,” says Lonny Bramzon. “We understand the pain and suffering these patients and their families have endured, and hope important it is for them to be able to close this chapter and finally begin the recovery process once and for all.”