Recall of DePuy ASR Hip Systems
27 August 2010
ASR Hip Replacement System & ASR Hip Resurfacing System
The Irish Medicines Board (IMB) is working with the HSE and Orthopaedic surgeons in relation to the worldwide recall announced yesterday by DePuy of their ASR Hip System.
Most hip replacements involving the ASR hip system have been successful. However, data recently received by DePuy shows that after 5 years approximately 12 per cent of patients who received the ASR hip require replacement of their implant, a higher rate than expected, and this has led to the recall.
The IMB has carefully monitored this product on the Irish marketplace and has been in on-going discussions with the company. The manufacturer confirmed that all stock has been removed from Irish hospitals. Approximately 3500 patients have received the ASR Hip System in Ireland since it became available in 2003. Twelve incidents have been reported to the IMB to date.
A hip implant is made up of ball and socket components that move against each other. The ASR components are made of metal and may wear over time. This is an expected process.
There are tests that will help orthopaedic surgeons determine if the hip is working as it should. Patients who have been implanted with the affected devices will be contacted in the coming weeks for review.
FOR FURTHER MEDIA INFORMATION:
Ger McCarthy/Orla Molloy Tel: (01) 676 01 68
Weber Shandwick 086 233 3590 or 087 770 5108
ABOUT THE IRISH MEDICINES BOARD
The Irish Medicines Board (IMB) is the competent authority for the licensing of human and veterinary medicines and medical devices in Ireland. Its role is to protect and enhance public and animal health through the regulation of medicines, medical devices and healthcare products.
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