Stryker Corporation continues to work to address issues raised in four recent FDA warning letters as the company faces more lawsuits concerning its Stryker Trident artifical hip medical device. The Stryker hip was the subject of a recall in January 2008 after the FDA found quality control issues at its manufacturing plants in Ireland and New Jersey. The recalled hip received numerous complaints from patients who continued to experience pain and discomfort from the implanted artificial hip. Other patients reported squeaking from improper wear of the Stryker devices. Both issues concerning the Stryker hip have resulted in lawsuits against the medical device company.
Stryker Trident hips are not the only company device that’s been the subject of a recall. In December 2008, Stryker issued a recall of its cranial implant kits citing a risk for infection due to a lack of proper sterilization.
Stryker has pledged to spend $150 million over the next few years to address quality control problems as well as a monitoring system that will better track adverse event reports so that device defects can be spotted earlier.
Many Stryker hip patients have had to undergo one or more revision surgeries to correct the defective hip originally implanted.