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Important Safety Information on Stryker Trident Hip Implants - Notice to Hospitals

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Contact: Marketed Health Products Directorate (MHPD)

NOTICE TO HOSPITALS
Health Canada Issued Important Safety Information on Stryker Trident Hip Implants

February 12, 2008

To: Hospital Chief of Medical Staff

Please distribute to the relevant Departments of Orthopaedic Surgery, and other involved professional staff and post this NOTICE in your institution.

Health Canada is aware of an international recall by Stryker concerning their Trident Hemispherical and Trident PSL Shells from their Cork Ireland facility. This has created a shortage of these products in various countries and has in certain cases delayed planned surgeries in Canada.

Health Canada is working in conjunction with Stryker and surgeons to manage the Canadian situation. As a short term measure, Health Canada has authorized the importation and sale of New Jersey manufactured implants through the Special Access Programme (SAP). 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, after reviewing United States Food and Drug Administration (FDA) warning letters as well as data provided by the manufacturer, determined that the devices manufactured at the New Jersey facility meet the requirements for distribution through the Special Access Programme (SAP).

Health Canada is accepting applications for SAP authorization for use of Trident Hemispherical and Trident PSL Shells manufactured at the New Jersey facility. These will be reviewed on a case by case basis. Physicians can find Application Forms for SAP release of products on the Health Canada Website.

According to Stryker Canada, no increased health risk to patients has been identified with the recalled products and the company has not recommended any additional action to be taken with respect to implanted joints at this time. Health Canada recommends that physicians follow up with their patients for any signs of device failure and report adverse incidents to the marketing authorization holder or to Health Canada.

Stryker has issued a recall notice concerning the affected products on January 24, 2008. According to information received from Stryker, corrective actions at the Cork facility have been implemented in early January and the supply issue is expected to be resolved by the end of February. At this time, the licensed products are expected to be fully available. In the meantime you may access products through the SAP at Health Canada or use licensed alternatives to prevent delays in surgeries.

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious or unexpected adverse incidents in patients using these implants or other medical devices should be reported to the marketing authorization holder or to Health Canada at the following address: