A Tennessee woman claims that Stryker Corporation failed to adequately warn consumers about the risks and severity of side effects associated with the Rejuvenate modular-neck stem hip implant.

Plaintiff Karen H. is suing the medical device company, Stryker Corporation, for the injuries she allegedly sustained from their Rejuvenate hip replacement system. Karen claims that in direct result of the metal-on-metal hip replacement, she suffered multiple complications and required corrective surgery.

After being advised by her physician that she would need a hip replacement, Karen opted to use the defendant’s Rejuvenate hip replacement modular system. Ideally, the metal hip implant would have allowed Karen to continue normal daily activities.

On Dec. 6, 2010, Karen underwent total left hip replacement surgery and a year later on Nov. 28, 2011, Karen then underwent a total right hip replacement surgery, using the Rejuvenate system. She had also reportedly suffered no immediate complications from both procedures.

At the time she was told about her options of hip implant systems, neither Karen nor her physician had been aware of the hip replacement complications associated with the defendant’s metal hip implant. On Jan. 27, 2013, Karen received a letter from her physician, which announced that Stryker Corporation was recalling the Rejuvenate and ABG II metal hip implant systems.

The Stryker hip recall letter detailed several health impositions that could cause major problems for the patients including metallosis, corrosion, infection, and the formation of pseudotumors. Soon after receiving the hip replacement recall letter, Karen had an MRI conducted on her hips, which revealed that pseudotumors were forming on each hip. Her physician recommended that she undergo corrective surgery to have the hip implants removed, in order to prevent any further hip replacement complications.

Karen had the left metal-on-metal hip implant removed in Spring 2013. According to the metal hip lawsuit, Karen’s hip revision surgery was very painful and recovery was difficult, and she is still currently under the supervision of her orthopedic surgeon. Her orthopedic surgeon states that she will eventually need to undergo the same procedure for her right hip, but will have to wait until she is in better health.

Karen is taking legal action against Stryker Corporation for failing to warn her about these potential hip replacement complications, and she says that her orthopedic surgeon should have been given special instructions. Karen insists that she never would have used the Rejuvenate system if she had known about the possibility of pseudotumors or any of the other associated hip replacement complications she suffered.

Overview of Metal Hip Implant Complications

Stryker Corporation sent recall letters to physicians and surgeons across the country in January 2013, warning them of the complications associated with their metal-on-metal implants, particularly the Rejuvenate and ABG II models. The complications mentioned in the letter included metallosis (blood-metal poisoning), metal corrosion, tissue infection, device failure, and the formation of pseudotumors. The Stryker hip recall letter went on to explain that these hip replacement complications were caused by the metal ions that are naturally shed into the bloodstream, when the metal ball-and-socket joint interact with each other.

Since this discovery, many experts have speculated about how such a design flaw could have passed the FDA’s rigorous safety requirements. Experts further explained that like many alternative metal-on-metal hip replacement implants the Stryker Rejuvenate system had been approved through the FDA’s 510(k) Premarket Notification Process. This policy allows a device to go to market without having to go through preclinical testing; the device must be shown to work at an equivalent level with a similar product that is already on the market.

Karen is taking legal action against Stryker Corporation, claiming the defendant was negligent in its manufacturing, selling and distribution of the Stryker Rejuvenate hip implant.

The Stryker Hip Lawsuit is Case No. 3:13-cv-00554, in the Circuit Court for Knox County, Tennessee.