A Florida man alleges, in a recently brought lawsuit, that he was implanted with a Stryker Rejuvenate metal hip stem device on his right side and, soon after, needed to undergo revision surgery to remove the device.
According to the lawsuit, the man was implanted with the Stryker Rejuvenate device on or around June 6, 2011. The man needed to undergo revision surgery on February 13, 2013 and the lawsuit alleges that the Stryker device caused him injury and economic loss.
The Stryker Rejuvenate and ABG II Hip Stem contains metal components that come in contact with one another, which can cause the release of metal ions. Many metal-on-metal hip implant manufacturers have recalled their products, including Stryker, which recalled both the Rejuvenate and the ABG II hip stem in June 2012. This year, Stryker Corp.’s second-quarter profits fell 34 percent and the device maker recorded a $170 million charge tied to the product recalls, according a MarketWatch.com report.
The U.S. Food and Drug Administration (FDA) has put the metal-on-metal implant class under greater scrutiny following reports of high failure rates and reports that the devices release high concentrations of metallic debris into patients’ bloodstream. This January, the agency released new guidelines for patients who are implanted with all-metal devices, including that symptomatic patients undergo routine physical examinations, diagnostic imaging, and metal ion testing.
A January 17 2013 FDA alert concerning adverse events associated with metal-on-metal hip implants, which can follow the surgery, including:
- Hip dislocation, which happens 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 who have been implanted with hip devices should be aware of potential symptoms that may occur three or more months following surgery that may indicate that 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 the ability to walk
- Noise, such as popping, grinding, clicking, or squeaking, emanating from the hip joint
New data from Canada suggests that metal-on-metal hip patients are likelier to have to undergo revision surgery within the first five years of implantation, according to CBC News. A Canadian Institutes for Health Information study found that people who have been implanted with metal-on-metal devices face a 5.9 percent increased likelihood of requiring implant replacement within five years compared to a 2.7 percent increased likelihood in patients implanted with metal-on-plastic implants.
National law firm, Parker Waichman LLP, filed this lawsuit on behalf of a Florida man who alleges that his Stryker Rejuvenate hip implant is defective and has caused him injuries. The lawsuit was filed on May 24, 2013, in New Jersey’s Superior Court of Bergen County (Docket No.BER-L-4085-13) and is one of many cases related to the Multicounty Litigation entitled In Re Stryker Rejuvenate Hip Stem and ABG II Modular Hip Stem Litigation, Case No. 296.