A Tennessee woman implanted with a metal-on-metal Stryker Rejuvenate modular hip stem brought a lawsuit against the device maker and alleges serious injuries, including having to undergo revision surgery.
According to the complaint, the woman was implanted with the Rejuvenate device on or about June 20, 2011. She was forced to undergo revision surgery to remove the device on approximately October 16, 2012. The complaint also notes that, following a blood test, the plaintiff was told that her blood contained abnormalities attributable to a defect in the hip implant.
The Stryker Rejuvenate and ABG II Hip Stems are constructed with metal components that grind together under the body’s weight. Following mounting injury reports and lawsuits, Stryker recalled both hip device products in June 2012. This year, Stryker Corp.’s second-quarter profit fell 34 percent and the medical device maker recorded a $170 million charge tied to the product recalls, according to MarketWatch.com.
The U.S. Food and Drug Administration (FDA) has since put this medical device class under increased scrutiny following reports of high failure rates and the release of high concentrations of metallic debris into the bloodstream. On January 17, 2013, the FDA released new guidelines for patients implanted with all-metal devices and advised that symptomatic patients undergo routine physical examinations, diagnostic imaging, and metal ion testing. According to the FDA alert, adverse events following surgery, regardless of the type of hip system implanted, include:
- Hip dislocation, when the ball of the femur (thigh bone) slips out of its socket in the pelvis (hip bone)
- Bone fracture
- Joint infection
- Local nerve damage with numbness/weakness
- Device loosening or breakage
- Difference in leg lengths
- Osteolysis (bone loss)
The FDA added that patients with hip implants should be aware of potential symptoms that may occur as early as three months after surgery and that may indicate their device is not functioning properly, including:
- Pain in the groin, hip, or leg
- Swelling at or near the hip joint
- A limp or change in walking ability
- Noise (popping, grinding, clicking, squeaking) from the hip joint
Depending on the severity of the adverse event(s), revision surgery may be necessary.
New data from Canada suggests that individuals implanted with metal-on-metal hips are likelier to require revision surgery within five years, according to CBC News. In fact, the Canadian Institutes for Health Information study indicated that individuals implanted with metal-on-metal implants faced a 5.9 percent chance of needing revision surgery within five years, compared to a 2.7 percent rate among those with metal-on-plastic implants.
This lawsuit was filed by the national law firm, Parker Waichman LLP, on June 26, 2013, in New Jersey’s Superior Court of Bergen County (Case No. 2-5036-13). This case is one of many related to the Multicounty Litigation entitled In Re Stryker Rejuvenate Hip Stem and ABG II Modular Hip Stem Litigation, Case No. 296.