Medical Products

Dáil Éireann Debate, Tuesday - 16 April 2013

Tuesday, 16 April 2013

Questions (1166)

Michael McCarthy

Question:

1166. Deputy Michael McCarthy asked the Minister for Health if his attention has been drawn to the alleged use of an allegedly defective hip product in a hospital (details supplied) for a defined period of time; if he will explain the delay between the surgeons raising concerns and the patients being notified; the date on which the Health Service Executive Serious Incident Management Team, that was appointed to investigate the issue, will make their findings public and to explain the delay in reporting back on an issue that was first raised in 2008; if he will confirm the reasons given by the manufacturer for the withdrawal of the product from the market; and if he will make a statement on the matter. [16344/13]

Written answers

Minister for Health (Deputy James Reilly)

I am advised by the Health Service Executive (HSE) that the Executive stopped using the product combination referred to by the Deputy in 2008 when the Executive discovered unexpected early joint replacement failure in a small number of patients. The product had been in use in two hospitals in Cork between 2005 and August 2008. A management plan and incident management team was put in place at the time to oversee the review/recall process. All the individuals potentially affected were identified and seen. The HSE have confirmed that all patients who required revision surgery have had revision surgery - others will be monitored via out-patient appointments.

The incident was notified to the HSE Serious Incident Management Team in June 2010 and a report has now been completed and conveyed to the HSE.

I have arranged to have the Deputy's question referred to the Health Service Executive for attention and a more detailed response.