Stryker Hip Implant Recall, Warning Letters Point to Serious ProblemsFeb 5, 2008 | Parker Waichman LLP
The FDA decided to take a hard look at Stryker after receiving an unusually high number of complaints from recipients of Stryker hip implants. Since 2005, Styker hip implant patients have reported a range of problems, including pain, difficulty walking and “squeaky” joints, and some have had pieces of implant parts break off or wear down unevenly. Those complaints prompted the FDA to inspect both the Mahwah, New Jersey and Cork, Ireland plants where most of the Stryker hip implants sold in the US are made. Those inspections resulted in the FDA issuing Stryker two warning letters.
The first, a seven-page letter dated March 15, 2007, cited several violations at the Ireland plant, including missed deadlines to fix failures in following procedures for testing problematic products and documenting risk. The heavily redacted letter refers to an earlier voluntary recall of “hip fracture stems” which appears to be related to the problems. It also cited several instances where the “root cause” of problems that caused that particular recall was not determined.
Then Stryker received another letter regarding the New Jersey facility. That letter, dated November 28, 207 said that the deficiencies uncovered during an inspection at the Mahwah, New Jersey facility had contributed directly to the manufacture of faulty hip implants. The FDA letter described a range of deficiencies, including “clusters” of Staphylococcus bacteria, the pathogen that causes staph infections, that was found throughout the plant. The November 28 letter states repeatedly that Stryker “failed to perform corrective and preventive actions in order to prevent the recurrence of nonconforming product or other quality problems.” For instance, in regards to the bacterial contamination, the letter states that Stryker “has not identified the root causes of the microorganism contamination and has not executed corrective and preventive action to prevent recurrence.”
Stryker’s problems came to a head on January 22, 2007, when the company issued a recall for more hip implant components made in the Cork, Ireland plant. The latest Stryker Hip Implant component recall involved two hip replacement cups – the Trident Acetabular PSL Cup and the Trident Hemispherical Cups – made at the Stryker facility in Cork, Ireland. Acetabular Cups are used in the socket portion of replacement hip components. The PSL version is the most commonly used Stryker cup in the U.S.
The Trident Hip Implant cup recall was implemented by Stryker amid concerns that the components could be contaminated with “manufacturing residuals” at levels that exceed company standards. However, Stryker maintained that the problems did not affect the sterility of the components, and claimed that patients who have received the recalled Trident components will not need to have them replaced.
Just a few days after the Stryker hip implant recall, Stryker President and CEO, Stephen P. MacMillan assured investors that there was no clinical evidence to suggest safety problems with the company’s products. In his remarks, MacMillan did not mention all of the complaints Stryker received from its hip implant recipients. Still, even he had to concede there are serious problems at Stryker. “You don’t get two letters in nine months and feel good,” MacMillan told his audience.