Stryker implants continue to plague patients
Manufactured by Stryker Orthopedics of Mahwah, New Jersey, a division of Kalamazoo, Michigan-based parent Stryker Corporation, Stryker hip replacement devices have concerned patients, doctors, and lawyers since 2008 when the company first issued a recall for its ceramic-based Trident Acetabular PSL Cup System and Trident Hemispherical Cup System. An acetabular cup is placed into the hip socket. The PSL version has been popular.
This first recall came on the heels of warning letters from the FDA.
In July 2012, the Rejuvenate and ABGII modular-neck hip implants were recalled again due to concerns about corrosion in patients who received them. These two implants are customizable. They conform to each individual’s body. The systems have four components, all made of metal:
- Femoral stem
- Modular neck
- Acetabular cup
When these metal components chafe against each other, metal shards or debris release toxins into the patient’s blood stream. Cobalt and chromium poisoning can result.
Stryker notified physicians and regulators of its recall. It also urged patients to contact their surgeons. It also terminated global distribution of these products.
Complications are well known
The following symptoms may characterize serious problems with a Stryker hip implant:
- Chronic pain
- Swelling around the area where the device was implanted
- Loss of mobility
- Loss of stability
- Loss of vision
- Loss of hearing
- Loss of bone
- Bone fractures
- Bone chipping
- Gastrointestinal issues
- Cardiovascular issues
- Hip dislocation
- Squeaking and popping sounds
Surgery may become necessary to remove or replace the hip implant that has caused damage. Given the customizable nature of the Rejuvenate and ABGII systems, surgery may translate to extensive recovery.
The FDA received 17,000 reports about problems with metal hip implants
In June 2012, the FDA asked an 18-member panel to recommend guidelines regarding use of metal hip implants. Originally manufactured with plastic or ceramic components, physicians began to favor metal for durability. About 400,000 Americans receive a hip replacement every year with the hope of regaining motion and relieving pain. In 2010, metal hip replacements represented about 27 percent of all hip implants. In 2008, they accounted for nearly 40 percent.
The FDA issued a warning to Stryker Orthopedics about its Trident systems in November 2007, based on a month-long, onsite investigation. The warning contained a litany of violations, stating the company failed to establish and maintain procedures for identifying the actions necessary to correct and prevent product and other quality problems. The FDA cited instances of continual complaints the firm received from January 2005 to May 2007 about the Trident systems that failed to function and that some of these problems required revision surgery. The FDA found Stryker’s responses to its concerns inadequate. At the core of the device problems are design and manufacturing flaws that were not corrected even when complaints were lodged, and marketing claims.
Stryker held accountable
While the FDA holds Stryker accountable, so does the law. In November 2013, a committee formed to represent plaintiffs around the country in Stryker hip replacement lawsuits. This lawsuit, filed in the U.S. District Court in Minnesota, could be one of the largest device lawsuits in the country. Stryker has estimated costs to reach more than one billion dollars in their exposure of 31,000 devices released for a period of two and a half years before it voluntarily recalled its devices in 2012. The suit represents thousands of affected patients.
More than 80 lawsuits have been filed in Stryker Orthopedics’ local Bergen County, New Jersey.
Stryker Lawsuit Attorneys in Chicago, Illinois
If you have had a Stryker hip replacement system implanted, contact Phillips Law Offices today to speak with an experienced Chicago products liability attorney. Call 312-346-4262 or contact us online today for a free consultation with an attorney about your case.