In a largely unprecedented process, Stryker reached a mediated settlement agreement involving thousands of lawsuits and has set aside $1.45 billion to settle claims over its failed hip system, which is no longer on the market. According to various reports, Stryker will pay $300,000 if a patient received and then had removed through revision surgery a failed Stryker hip. Were both hips involved in such fashion, the compensation would double to $600,000.
There could also be additional compensation for complications arising from revision surgery. Removal of a failed implant is often a more complicated procedure than the initial installation of the implant.
Patients have to show that hips were received and then removed through revision surgery on or before November 3 of this year - the date of the settlement - and to also have proof of the hip implant in the form of a product label that is kept on file by the facility at which the hip implant initially took place.
Unlike other all-metal devices that have proven problematic in recent years, the Stryker Rejuvenate Modular-Neck and ABG II Modular-Neck systems were not exclusively all-metal artificial hips. However, there were sufficient combinations of metal alloys that proved to be problematic for patients suffering from soft tissue inflammation and injury pertaining to the soft tissue surrounding the joint, caused by minute metal particles wearing away from the joint.
Many other patients were found to suffer from Stryker Orthopedics Metallosis, a toxic condition that results from metal ions getting into the bloodstream. Regardless of any other kind of failure related to the artificial hip system, metallosis alone is sufficient grounds to remove an all-metal or metal-based artificial joint in order to protect a patient’s long-term health.
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All-metal implants were part of a new breed of implant that was fast-tracked through the approval process governed by the US Food and Drug Administration (FDA). The compressed approval holds that a new device that essentially features a design similar to that already on the market can escape the normally rigorous vetting process. The use of metal was thought to extend the lifespan of the joint and would reduce the frequency of replacements - an important consideration given the aging baby boomers. At one time, one in three hip implants featured an all-metal design.
However, the reality has been far different, with upwards of 8,000 patients filing a Stryker recall lawsuit. The manufacturer recalled the problematic devices in 2012.