Stryker CEO Talks of “Work to Do” Following FDA Warning, Hip Implant Component RecallJan 25, 2008 | Parker Waichman LLP
The head of Stryker Corp., the manufacturer of defective hip implants and other joint replacement components, told analysts on Wednesday that the company “has work to do”. That might qualify as the understatement of the year. Stryker has been receiving complaints about its defective hip implants since at least 2005. In a short 9 month period, Stryker received two Food & Drug Administration (FDA) warning letters, and just this week, the company recalled some of its Trident Hip Implant components.
The fact that Stryker has work to do won’t come as a surprise to many recipients of the company’s defective hip implants. These patients have complained about problem hip implant components for years, to no avail. 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.
All the complaints led the FDA to conduct inspections of the company’s manufacturing plants in New Jersey and overseas in Cork Ireland. Just last week, a warning letter Stryker received from the agency dated November 28 was posted on the FDA website. The FDA warning letter 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.”
Shockingly, this was not the first warning letter Stryker received in 2007 from the FDA. Dated March 15, 2007, another seven-page letter 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.
But two warning letters in nine months was not the worst of it. Stryker added to its woes earlier this week when it 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 that patients who have received the recalled Trident components will not need to have them replaced.
While stressing that there was no clinical evidence to suggest safety problems with the company’s products (apparently 3 years of complaints from hip implants do not count as “clinical evidence”) Stryker President and CEO , Stephen P. MacMillan told investors and analysts during a conference call that the company was doing its best to fix its quality control issues. ``This is really frustrating and disappointing,'' MacMillan said of two FDA warning. ``You don't get two letters in nine months and feel good."