Stryker Corp. Gets FDA Warning Letter Following Inspection, Hip Implant ComplaintsJan 16, 2008 | Parker Waichman LLP
Stryker Corp., the maker of the Trident Hip Implant and other hip replacement parts, received a warning letter from the Food & Drug Administration (FDA) after problems where found at the company’s Mahwah, New Jersey plant during an FDA inspection. The inspection at the Stryker facility, which took place June 12 and July 1, 2007, uncovered problems that led to the manufacture of defective medical devices, including the Trident Hip Implant.
According to the FDA warning letter, which was dated November 28, 2007, the medical devices made at the Stryker Corp. plant in New Jersey included the Trident Hip Implant components, as well as the ReUnion Plasma Spray Humeral Stem, Solar Plasma Purefix HA Shoulder Stems, Trident PSL Acetabular Shells, Duracon Toatal Knee Modular Femoral Component, hip implants with ceramic bearing components, and Global Modular Hip Stems. In its letter, the FDA said Stryker had received complaints from January 2005 to April 2007 "for squeaking noises of hip implants with ceramic bearing components." According to the letter, some of the hip replacement component problems resulted in additional surgeries for implant failures such as fractures and pain.
According to the company's most recent financial report, Stryker's hip, knee and shoulder implants are a major generator of revenue for the company, with worldwide sales of $2.6 billion for the first nine months of 2007.
The FDA warning letter said that problems found during an inspection of the Stryker Facility were directly linked to the defective implant components. Those problems included failing “to establish and maintain procedures for identifying all of the actions needed to correct and prevent the recurrence of nonconforming product and other quality problem” related to complaints the company received between January 2005 and April 2007, and “verifying or validating the corrective and preventive action to ensure that such action is effective .” The FDA letter also said that previous responses it had received from Stryker regarding problem found during the 2007 inspection of the New Jersey facility were inadequate.
In a written statement, Stryker officials responded to the letter, saying: "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, including those administered by the U.S. FDA and regulatory bodies in other countries in which Stryker conducts business. We have been working diligently since July 2007 to respond to the FDA and will continue to work closely with them to address these matters."
According to Reuters, the FDA sends dozens of warning letters each year. Most are resolved without further action. In rare cases, the letters can result in product seizures or hold up approval of new products.