Advisory

2001-101
September 20, 2001

Voluntary recall of some ceramic hip replacement devices

OTTAWA - Health Canada is advising Canadians that specific lots of zirconia ceramic femoral head hip replacement devices manufactured by Saint Gobain Advanced Ceramics Desmarquest of France are being recalled by Canadian distributors due to an unusually high rate of failure after implantation with one particular lot.

The recall applies to unimplanted devices manufactured since 1998 that have been found to be more susceptible to spontaneous fractures. Although the failure rate is higher than expected, not all zirconia ceramic femoral heads made by St. Gobain Advanced Ceramics Desmarquest after 1998 will fail. It is important to note, therefore, that not all patients who have these zirconia ceramic femoral heads made after 1998 will experience failure of their implants.

Health Canada is currently gathering information to determine the exact number of defective devices imported into Canada and which may have been implanted into Canadian patients. Approximately 20,000 hip replacements are implanted in Canada each year. Canadian companies estimate that zirconia femoral heads are used in less that 5 per cent of these 20,000 annual hip implant replacement procedures.

The recall was initiated by the Canadian distributors of the device, which include:

• Biomet Canada Inc., Oakville, Ontario,
• DePuy Canada Ltd., Markham, Ontario;
• Smith & Nephew Inc., St-Laurent, Quebec;
• Stryker Canada, Burlington, Ontario; and
• Zimmer Canada Ltd, Mississauga, Ontario

The defect in the identified lots is in the femoral head, which is the ball portion of the ball-and-socket joint that makes up the zirconia ceramic device. This appears to be the result of a change made in the manufacturing process. According to information obtained so far, the defective devices tend to fail between 13 and 27 months after implantation.

There are currently no tests available to predict if or when a device will fail. Patients will notice a sudden onset of pain in the implanted hip joint if the implant fails.

Health Canada has notified Canadian hospitals and orthopaedic surgeons of the recall and is recommending that surgeons who have implanted the defective devices inform their patients of the increased risk.

Similar recalls of this device are being issued in other countries, including the U.S., the U.K. and Australia.

Health Canada will continue to monitor the progress of the recall.

Media inquiries:
Roslyn Tremblay
Health Canada
(613) 957-1588