UP TO 400 patients who had their hip replaced may need corrective procedures, including repeat surgery, following the recall of a widely used hip implant.
All 3,500 patients who had their hip replaced with the faulty ASR replacement implant at the centre of a worldwide recall are to be contacted by the hospital in which the procedure was carried out, the HSE said yesterday.
The Irish Medicines Board said it had received reports of 12 incidents involving the ASR Hip System made by DePuy Orthopaedics since it was introduced in 2004.
Based on UK data, which has revealed problems in about 12 per cent of devices, more than 400 Irish patients could require corrective procedures to remedy the problems experienced with the product.
The board, which is working with the HSE and orthopaedic surgeons on the recall, said patients who had been implanted with the affected devices would be contacted in the coming weeks for review. The recalled products were more often used on younger patients in need of hip resurfacing rather than older patients requiring a complete hip replacement.
The HSE said it had contacted management and staff in all hospitals where orthopaedic surgery is carried out. Orthopaedic consultants were assessing the risk to patients who received the device. “Hospitals will be contacting all affected patients directly and will take all steps necessary to ensure patients receive appropriate follow up.”
While most hip replacements involving the ASR system have been successful, the UK data shows that after five years about one patient in eight required replacement of the implant. This was higher than expected, triggering the recall.
The medicines board said it had carefully monitored the product in Ireland and was in “ongoing discussions” with the company. It said the manufacturer had confirmed that all stock has been removed from Irish hospitals.
Problems have arisen with two devices, the ASR XL Acetabular System and the DePuy ASR Hip Resurfacing System, which were discontinued last year. About 93,000 people around the world use the devices.
A hip implant is made up of ball and socket components that move against each other. The components are made of metal and may wear over time. This is expected.
However, problems with the ASR device include loosening parts, infections, fractures, dislocation, metal sensitivity and pain.
DePuy said it would pay for the cost of doctor visits, tests and procedures associated with the recall.
