No approval system was in place when the Capital hip, made by 3M Healthcare, was introduced, and there was no monitoring system to detect problems when they developed.
Yesterday, the department issued a hazard warning about the device and said all patients who have received it must be traced and recalled for examination followed by a repeat operation where necessary.
The Capital hip was one of the cheaper devices on the market, priced at pounds 250-pounds 350. It was withdrawn in the UK in March last year for "commercial reasons", according to the company, although it is still sold overseas. There had already been early reports of problems and it is likely these had hit sales. In some patients the shaft inserted into the femur (thighbone) worked loose and eroded healthy bone.
Dr Jeremy Metters, the Government's deputy chief medical officer, said the Capital hip had been distributed to between 90 and 100 hospitals in Britain and hard evidence of its high failure rate had become available from three hospitals only last week. That showed one in five of the hips had failed over five years compared with an expected rate of one in 10 over 10 years.
Dr Metters said first reports of problems with the hip two years ago had been followed up but the department had been unable to gather the necessary evidence.
"My worry was that we deliberately went out to gain that evidence and we were unable to obtain it. We tried very hard."
He said that the Government would now consider setting up a national register of orthopaedic implants, as operated in Sweden, to keep track of devices and pick up problems early.
"There are 11,000 medical devices and to keep tabs on all of them is inappropriate. However, we have to look to see if there is a better way to keep in touch with orthopaedic implants." Under European Union regulations which take effect in June, all devices will have to be licensed before being marketed.
More than 250,000 hip replacements took place in Britain between 1991 and 1997 so fewer than one in 50 received a Capital hip but neither patients nor GPs will know who they are, Dr Metters said. The task of tracing them will fall to the hospitals and will take several months, he said. The situation was not urgent and patients who were not contacted need not worry.
The cost of recalling and re-operating on affected patients could exceed pounds 20m but the department said it was "too early" to say whether it would be seeking compensation from the company. BUPA said all private patients treated in BUPA-owned hospitals would be covered for investigation and repeat operation, whether or not they were members of BUPA.
Janine Tobias of the Manchester-based solicitors Pannone said patients affected could have a claim for compensation under the Consumer Protection Act 1987. "All they have to prove is that the product is defective and they have suffered injury," she said.
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