The Medical Devices Agency issued a hazard warning last night about the Capital hip made by the 3M company. Launched in 1991, it is one of more than 40 artificial hips on the market.
The warning will mean many, mostly elderly, patients will have to undergo complex revision surgery, which is riskier than the original hip replacement operation, imposing a heavy burden on the NHS. Each revision operation costs over pounds 5,000 and if all 5,000 patients had repeat surgery it would account for half the entire workload of repeat hip replacements undertaken by the NHS each year.
Richard Villar, consultant orthopaedic surgeon at Addenbrooke's hospital, Cambridge, said: "This is a major surgical drama. It will tie a lot of surgeons down for a long time. Waiting lists will increase enormously and they are long enough as it is."
It was unclear last night what the nature of the problem with the device is or whether all, or only some, of the patients fitted with it will require repeat operations. It appears that the device works eroding healthy bone, which causes fractures and reduces the success rate of further hip replacement operations.
The Department of Health called a press briefing for 9.30am this morning and the company has set up a helpline for patients.
More than 46,000 hip replacements are carried out each year on patients who have difficulty walking because of arthritis.
The replacement hip consists of a metal ball and shaft which is fitted into the thighbone and a socket made of plastic or metal into which the ball is inserted to form a new joint.
More than 90 per cent of replacement hips are expected to last 15 years, but failure rates vary widely. The most frequent cause of failure is loosening of the joint as a result of wear and tear.
The Capital hip was based on the famous Charnley design, the original hip replacement, invented in the 1960s which, has never been bettered.
Concerns were raised about the Capital hip last year when surgeons from Harlow Wood Orthopaedic Hospital, Nottingham, published a paper in the British Journal of Bone and Joint Surgery which revealed that up to 26 per cent of patients experienced an early failure of the implant. On average they lasted just over two years. Different materials have been tried in the devices to overcome such problems.
The materials and quality of manufacture are controlled by the Medical Devices Agency but the devices are not required to undergo long-term clinical trials before being introduced.
The Capital hip helpline number is 01509 613038Reuse content