Anxious wait for thousands of Irish patients over recall

AROUND 3,500 Irish patients received a replacement hip system which is now being recalled worldwide because of its high failure rate.

The DePuy Orthopaedics unit of Johnson & Johnson has recalled hip implants that failed earlier than expected in some patients.

The Irish Medicines Board (IMB) said it had received reports of 12 incidents involving the ASR hip system since it was introduced in 2004.

The IMB said data received by DePuy showed that around 12% of patients who received the ASR hip required replacement of the implant after five years.

It said the failure rate was higher than expected and had led to the recall.

The IMB said it had carefully monitored the produce on the Irish market and had been involved in ongoing discussions with the company. It said the manufacturer has confirmed that all stock has been removed from Irish hospitals.

The IMB explained that 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,” the IMB stated.

The IMB said there were tests that would help orthopaedic surgeons determine if the hip was working as it should.

It added that patients who had been implanted with the affected devices would be contacted in the coming weeks.

The Health Service Executive said it became aware of the safety notice from DePuy on Thursday evening and has notified staff in all of the hospitals where orthopaedic surgery is carried out.

“Hospitals have been advised that this product should not be used in any hip replacement surgeries with immediate effect,” it stated.

The HSE said orthopaedic consultants were assessing the risk to patients who received the device and it was now identifying all patients who might have received the device as part of their hip replacement.

“Hospitals will be contacting all affected patients directly and will take all steps necessary to ensure patients receive appropriate follow up,” it said.

The HSE said it would be liaising closely with the Irish Medicines Board and the manufacturers of the device as part of this ongoing process.