Stryker Gets Another FDA Warning LetterMay 5, 2008 | Parker Waichman LLP
Stryker Corp. has been hit with another Food & Drug Administration (FDA) warning letter, the medical device maker's second since last November, and the third in a little over a year. This time, the FDA took Stryker's biotech division to task for quality systems and compliance issues at its Hopkinton, Massachusetts, location. One of the issues cited by the FDA warning letter involves falsification of hospital-approval documents used under an FDA rule that allows device sales on a very limited basis.
The past year or so has been a rough one for Stryker. In January, Stryker recalled some of its hip implant components made under the popular Trident line because of possible contamination issues. The 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 recall came after Stryker received two FDA warning letters about conditions at the Ireland plant, as well as a factory in New Jersey that also makes hip implants. 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 referred to an earlier voluntary recall of “hip fracture stems” which appeared 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, 2007 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.”
This third warning letter involves the company's biotech division, a small segment of Stryker's business that makes products to promote bone growth. The letter concerns observations made during an inspection that began in September 2007. The letter cites issues relating to the division's handling of a past clinical study, its quality system, including medical device reporting procedures, and the falsification of hospital Institutional Review Board documentation used to approve implantation of Humanitarian Use Device. No products have been recalled as a result of the letter.
Stryker says it is taking the FDA warning "very seriously" and has already taken steps to deal with the problems. The small number of field sales employees behind the falsified documents are no longer with the company, Stryker said. The company said it also launched a company-wide 'quality action plan' aimed at strengthening oversight.