TRENTON, N.J. - Federal regulators have ordered medical device maker Stryker Corp. to fix a host of longstanding problems in its manufacturing of hip replacement parts that have triggered multiple patient complaints and forced some follow-up surgeries.
The Food and Drug Administration told Kalamazoo, Mich.-based Stryker in a letter that it was aware the company has received patient complaints since January 2005 about problems, including fit of implants that caused bone fractures. Patients also have complained about pain, difficulty walking, and "squeaky" joints.
The letter was prepared after FDA officials spent six weeks last summer inspecting the company's orthopedics division headquarters in Mahwah, N.J., which houses manufacturing operations.
A statement from Stryker said: "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."