Stryker Hip Implant Recall Creates Shortage in CanadaFeb 15, 2008 | Parker Waichman LLP
The Stryker hip implant recall has caused a world-wide shortage of these products and is prompting Health Canada to import equivalent products from the US. Stryker Orthopaedics recalled its Trident hemispherical and Trident PSL Shells from their Cork, Ireland facility on January 24th of this year. Acetabular Cups are used in the socket portion of replacement hip components. The PSL version of this component is the most commonly used Stryker cup in the U.S. Stryker Canada claims that there is no increased health risk to patients that have been identified with the recalled products. But, the Stryker recall has caused some planned surgeries in Canada to be delayed.
To help manage the shortage, Health Canada has authorized the importation and sale of the Trident implant components manufactured in Stryker’s New Jersey facility. "These authorizations were based on information received by Health Canada that significant delays in scheduled and emergent hip implant surgery would occur if these implants were not made available," Health Canada said in a notice to hospitals published online Tuesday. The use of the New Jersey-made implants will be reviewed on a case-by-case basis.
Stryker Corporation issued its recall of its Trident Hip Implants just days after the Food & Drug Administration (FDA) posted a warning letter on its website regarding serious deficiencies at its New Jersey plant. The Stryker hip implant components involved were manufactured at the company’s manufacturing facility in Ireland, which was also the subject of an earlier FDA warning letter.
The FDA implemented a review of the Stryker plants after receiving an unusually high number of complaints from patients receiving Stryker hip implants. Since 2005, patients receiving Stryker hip implants have reported a wide range of disturbing problems, including pain, difficulty walking, and “squeaky” joints; some patients have had pieces of the implant parts break off or wear down unevenly. Following these reports, the FDA inspected both the Mahwah, New Jersey and Cork, Ireland plants where most of the Stryker hip implants sold in the US are made.
The FDA reports and letters cited several violations at the Ireland plant, including missed deadlines to fix failures, not following procedures for testing problematic products, and not documenting risk. Stryker received another letter from the FDA regarding the New Jersey facility that warned of deficiencies uncovered during an inspection that had contributed directly to the manufacture of the faulty Sryker hip implants. This FDA letter described a range of deficiencies that included “clusters” of Staphylococcus bacteria, the pathogen that causes staph infections. Staphylococcus bacteria was found throughout the plant and the warning letter stated repeatedly that Stryker had “failed to perform corrective and preventive actions in order to prevent the recurrence of nonconforming product or other quality problems.” For instance, regarding the bacterial contamination, the letter states that Stryker had ‘not identified the root causes of the microorganism contamination and has not executed corrective and preventive action to prevent recurrence.”