Thousands of Irish patients who were fitted with metal-on-metal artificial hips are to be reviewed by consultants amid concerns over high failure rates for the devices.
The Health Service Executive is ordering a major review of all patients fitted with metal-on-metal artificial hips after international evidence showed that significant numbers are experiencing problems with the devices after a number of years.
A HSE spokeswoman described the move as “a review rather than a recall” and said that, where required, consultants would order additional tests for patients.
About 6,500 metal-on-metal artificial hips, usually made with cobalt and/or chromium, have been fitted to Irish patients.
A similar investigation was begun last year by the UK’s medical devices regulatory agency, the MHRA.
Review plans
The HSE will issue letters next week to all regional directors, its spokeswoman said yesterday, setting out the plans for a national review. The review will cover 3,500 ASR hip devices made by DePuy and another 3,000 from other manufacturers.
DePuy recalled the ASR hips in 2010 over concerns about the failure rate. About 600 patients are suing the company in the Irish courts over the problems they experienced with the device, while a further 300 cases are being taken by public patients against the HSE.
Database
The review comes as a new database of all knee and hip joint replacement surgeries is being established.
From September, the Irish National Orthopaedic Register, operated jointly by the HSE and the Royal College of Surgeons, will log the performance of medical devices and the activity of the surgeons who fit them.
Similar databases in other countries were credited with spotting the problems with DePuy hips at an early stage.
