| The U.S. Food and Drug Administration (FDA) has issued a third warning to the Stryker Corporation since last year over quality and compliance issues – this time for operations at a Massachusetts-based facility.
Details of the warning
The FDA’s warning letter was sent to Stryker Biotech, a smaller division of the company located in Massachusetts which makes bone-growth products used in spinal surgery. The letter accused the company of quality and compliance deficiencies including falsifying hospital approval documents, having inadequate procedures for clinical studies and also criticized the company for how device reports and product complaints were handled. Stryker has said that is working to fix these issues, but industry analysts seem to be saying that the company isn’t doing enough and point to how it handled problems related to hip replacements.
Hip replacements still a problem
Patients with Stryker’s Trident PSL and Hemispherical Acetabular Cups say there are still major problems with these products. In fact, they’ve been complaining to the company about it for years, but say that the company has done little to address their concerns.
Stryker’s Trident line of hip implants uses ceramic-on-ceramic components rather than metal-on-metal or metal-on-plastic components. Patients have complained about pain, difficulty in walking, pieces of the ceramic materials breaking off and wearing unevenly and perpetual squeaking. Nearly 11 percent of patients experience squeaking. To listen to one patient’s squeaking hip, click here.
Earlier warnings show similar concerns
Earlier warning to the company over its hip replacement products show similar concerns. The FDA, in a previous letter to Stryker made public earlier this year, said that the company has “failed to implement adequate corrective and preventive actions . . . in order to prevent the recurrence of nonconforming product and other quality problems.” The letter came after the FDA inspected Stryker’s Mahwah New Jersey plant last year.
If you are experiencing problems with Stryker’s Trident PSL and Hemispherical Acetabular Cups, contact an experienced attorney who has been following this issue to discuss your situation. For a free, no-obligation consultation, please click here.
|
