Federal regulators ordered medical devicemaker Stryker Corp. to fix a host of long-standing problems in its manufacturing of hip replacement parts that have triggered multiple patient complaints and forced some to have follow-up surgeries.
According to a warning letter the Food and Drug Administration sent to Kalamazoo, Mich.-based Stryker, the company has received patient complaints since January 2005 about a range of problems, including improper fitting of hip implants that caused bone fractures. Patients also have complained about pain, difficulty walking and ''squeaky'' joints, and some have had pieces of implant parts break off or wear down unevenly.
The six-page warning letter was prepared after FDA officials spent six weeks last summer inspecting the company's orthopedics division headquarters in Mahwah, N.J.
We take these matters very seriously and are committed to developing, manufacturing and marketing medical products that are safe and effective and that comply with applicable laws and regulations, said Stryker officials in a prepared statement said. Stryker was among five companies that in September 2007 agreed to pay $310 million and accept federal monitors to settle allegations they gave doctors kickbacks to use their products. -- by the Associated Press