Weitz & Luxenberg is no longer accepting Stryker Hip Implant Cases

FDA issues two warnings against Stryker on hip implants components that may be defective.

NEW YORK, NY--Orthopedic implant maker Stryker Corp. has been issued two stern warnings by the U.S. Food and Drug Administration (“FDA”) this year about problems at its manufacturing facilities that may have led to numerous complaints from patients who were fitted with the manufacturer’s orthopedic hip implant components, including its Trident hip implant. Some of these may be defective.

The most recent warning letter, dated November 28, 2007 and posted on the FDA’s Web site on January 15, relates to inspections of the New Jersey plant last summer that raised quality issues with several products. The federal agency specifically cited the firm’s failure to properly identify and correct recurring problems with some of its hip implant devices.

“We have successfully represented many clients involved with medical device problems in the past, and are well acquainted with manufacturers’ attempts to put profits ahead of safety,” said Paul Pennock, head of Weitz & Luxenberg’s medical device litigation unit. “Stryker’s apparent disregard for the FDA’s repeated warnings suggests that patients will need the strong legal representation for which this firm is historically recognized.”

Stryker has received numerous complaints concerning their Trident Hemispherical and Trident PSL cups, which have failed to function, and hip implant components that have poor fixation. In some instances, the FDA noted that these problems have required revision surgeries.

Complaints were also received for squeaking noises of hip implants with ceramic bearing components, which have apparently also resulted in revision surgeries. Symptoms include bone fractures, pain, wear particles, and broken fragments, the FDA said in its second warning letter to Stryker. “Your firm has failed to implement adequate corrective and preventive actions . . . in order to prevent the recurrence of non-conforming product and other quality problems,” the FDA warned.

Stryker, headquartered in Kalamazoo, MI, and formally known as Stryker Howmedica Osteonics Corp., has responded to the FDA at least four times since August, but the FDA deemed the responses to be inadequate. The manufacturer’s most recent response: “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.” The company said it would continue to work closely with the FDA to address matters raised by the letter.

The FDA warning letter addressing the firm’s procedures at its Mahwah, N.J., plant was the second warning issued to Stryker in the past year. Another letter, issued last March, involved a plant based in Ireland that makes knee implant parts and hip implants.

Weitz & Luxenberg has built a reputation as one of the country’s foremost medical device law firms, helping thousands of people receive significant financial compensation for their injuries. The firm is currently working for patients affected by a worldwide recall of implantable “Sprint Fidelis” heart defibrillator leads manufactured by Minneapolis-based Medtronic, Inc.

Implant patients who have undergone revision surgeries stemming from Stryker orthopedic components, or who have suffered emotional injuries due to malfunctioning implants, should fill out the form on this page for a free legal review of your hip implant case. We will be in touch shortly.

see also:

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Stryker's First Response to FDA Warning Learn from our lawyers about the FDA letter to Stryker
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News & Warnings Read the FDA Warning Letter re: Stryker Hip Implants.
FDA issues Warning Letter re: Stryker Hip Implants. Get the info here.