IMPORTANT MEDICAL DEVICES SAFETY INFORMATION

Date: 2001-08-27

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Contact
MDB

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Health Products and Food Branch
Direction générale des produits de santé et des aliments

August 27, 2001

Recall of Specified Batches of Zirconia Ceramic Femoral Heads for Use in Hip Replacement

Dear Health Professional(s),

Several orthopedic manufacturers are recalling unimplanted Zirconia Ceramic Femoral Heads, specified as having been fabricated by Saint Gobain Advanced Ceramics Demarquest, France, after 1998. The reason for the recall is an increased rate of spontaneous fracture post-implantation.

You are advised as follows:

• Do not implant Zirconia Ceramic Femoral Heads until the relevant manufacturer has confirmed which products are affected by the recall.

• Return product affected by the recall to the relevant manufacturer.

• Inform Health Canada of any cases of Zirconia Ceramic Femoral Head fractures by calling the Medical Devices Problem Reporting Hotline at 1-800-267-9675.

Recommendation:
Health Canada recommends that surgeons who have implanted Zirconia Ceramic Femoral Heads from lots identified as being at higher risk of fracture, inform their patients of the increased risk.

Discussion:

• The French health authorities (AFSSAPS) have advised Health Canada of 61 reports of fracture of Zirconia ceramic femoral heads manufactured by St. Gobain Advanced Ceramics Desmarquest. The problem is believed to be due to a change in manufacturing process in 1998.

• Failures are reported to have occurred between thirteen and twenty-seven months post-implantation at rates of up to 8.8% of implicated devices.

• St. Gobain had supplied the affected zirconia ceramic heads to orthopaedic manufacturers supplying Canadian hospitals. These manufacturers are recalling affected products and have issued advice to hospitals in receipt of these products. Health Canada supports this action, and recommends that zirconia ceramic femoral heads supplied by these manufacturers not be implanted until the manufacturer has confirmed which products are affected by the recall.

• This notice does not affect zirconia ceramic femoral heads supplied by other manufacturers not sourced from St. Gobain Advanced Ceramics Demarquest or femoral heads manufactured of alumina ceramic.

For further information, please contact the manufacturer of the device, or

original signed by

Beth Pieterson
Director, Medical Devices Bureau
beth_pieterson@hc-sc.gc.ca
Tel: 613 957-4786