Sir Julian Lewis: To ask the Secretary of State for Health and Social Care, what recent estimate he has made of the number of NHS patients harmed by cobalt poisoning from modular neck hip replacements in each of the last three years. [9691]

[Due for Answer on 22 October. Answered on 24 October.]

HOLDING ANSWER: The Department of Health and Social Care has indicated that it will not be possible to answer this question within the usual time period. An answer is being prepared and will be provided as soon as it is available.

ANSWER 

The Minister of State for Secondary Care (Karin Smyth): The Medicines and Healthcare products Regulatory Agency (MHRA) is aware of concerns regarding modular neck hips and the risk of cobalt poisoning. We are investigating the issue with our stakeholders including the British Orthopaedic Association, British Hip Society, and the National Joint Registry to support. The term modular neck covers a broad range of designs, and adverse incident reports of this sort typically include descriptions of symptoms rather than a definitive diagnosis of cobalt poisoning. In addition, it is not possible to uniquely identify cobalt poisoning from hip replacements in the ICD-10 coding scheme currently used in Hospital Episode Statistics. The UK Medical Devices Regulations provide clear requirements for manufacturers to undertake post-market surveillance activities to ensure safety action is taken, when appropriate. The MHRA is working towards implementing a future regime for medical devices regulation. This will put in place strengthened legal requirements for how manufacturers monitor and report on their devices once they are being used in the real world.