A medical device company has issued an urgent safety notice after discovering problems with hip replacement devices thought to have been fitted in hundreds of NHS patients.
DePuy Orthopaedics - a subsidiary of Johnson and Johnson - issued an “urgent field safety notice” to all UK hospitals last week instructing them to not implant any further devices held in stock and to recall any patients implanted with the devices for checks.
The voluntary product recall and instruction to review all patients follows fresh evidence that patients implanted with the hip resurfacing and full replacement devices have needed replacement surgery at more than twice the expected rate.
The notice to all NHS hospitals – issued in tandem with similar recall notes worldwide - said as yet unpublished data from the UK National Joint Registry showed that, on average, between 12 and 13 per cent of patients implanted with DePuy’s so-called ASR devices for metal-on-metal total hip replacements and resurfacing procedures needed to have their operation repeated within five years.
A spokeswoman for DePuy said the “generally accepted” standard was a revision rate of less than 5 per cent after five years.
The UK recall notice was issued in a letter from DePuy’s vice president for worldwide clinical affairs Pamela Plouhar. In it she warned “a small number” of patients may develop “progressive soft tissue reactions” from metal debris resulting from the device. The letter recommends patients are reviewed “at least annually” for five years after their implant and if necessary given blood tests or MRIs to measure metal ion levels.
DePuy said it was not able to say how many UK patients had been implanted with its devices but estimated 93,000 patients globally had an affected implant.
Figures from the 2008 National Joint Registry annual report suggest at least 900 UK patients were implanted with an ASR resurfacing device in 2008 alone and the Medicine and Healthcare Products Regulatory Agency says the affected devices are used in 257 clinical centres in the UK.
In her letter, Ms Plouhar said DePuy “intends to cover reasonable and customary costs” for monitoring and treating affected patients.
The affected products have already been the subject of two separate MHRA device alerts this year in April and May. However, the May alert focused on the possibility surgeons had not followed the manufacturer’s guidance in installing the devices at a stated angle.
The latest voluntary recall makes less reference to the possibility of surgeon error. Asked if that was an acknowledgement there were problems with the devices themselves, a spokeswoman for DePuy said: “The performance of any joint replacement system is dependent on a complex interaction of many factors including surgical technique, patient considerations and other factors. Beyond that, we do not understand why more hips than expected need to be revised, but we believe it’s in the best interest of patients to have their hip replacements evaluated annually.”