FOI release

Freedom of Information request (FOI 22/1003)

Published 17 January 2024

21st October 2022

FOI 22/1003

Dear

Thank you for your letter dated 16th September 2022, which requested information on:

1) The outcome of your case,

2) Any other Yellow Card incidents relating to the model, batch, or expiry of bone cement used in your case,

3) Any other incidents relating to the healthcare professional responsible for your care.

Firstly, I am sorry to hear of the ongoing issues you are experiencing because of your surgery. I wish you well in your recovery.

For background, it may be helpful if I describe the role of the Medicines and Healthcare products Regulatory Agency (MHRA) and the work that we do. The MHRA is a government agency that has responsibility for the regulation of medicines and medical devices and is responsible for ensuring that medicines, healthcare products and medical equipment are safe for those who use them. Both patients and healthcare professionals are encouraged to report problems with these products to the MHRA using the Yellow Card Scheme ([Yellow Card

Making medicines and medical devices safer (mhra.gov.uk)](https://yellowcard.mhra.gov.uk/))

In response to question 1 and 3, your letter did not contain a reference to a MHRA incident report, nor could we locate a report where you were the reporter or identified as the patient. If the report was made by your healthcare professional, they may not have included patient details within the case. Therefore, please can you provide the reference number for your incident when reported to the MHRA or contact the hospital/healthcare professional who reported the incident and ask them for the outcome of the investigation. I apologise if this appears to be very unhelpful. However, the MHRA is bound by strict rules of confidentiality (FOI exemption 41, please see below) and we are unable to disclose the sources of adverse incidents reported to us. Furthermore, reports that we receive from hospitals rarely provide us with the personal details of patients. Therefore, it is very difficult to confirm with absolute certainty that a report relates to a specific patient.

Similarly, and unfortunately, for question 3 the information is exempt from release under section 41:

Section 41 – Information provided in confidence: information provided to us in confidence, with the expectation that it will not be released, is exempt from disclosure under the FOI Act. Information will be covered by Section 41 if: it was obtained by the authority from any other person; its disclosure would constitute a breach of confidence; a person or organisation could bring a court action for that breach of confidence; and that court action would be likely to succeed.

In regard to question 2, we are pleased to be able to provide you with information on the number of incidents relating to bone cement. A total of 120 incident reports have been received by the MHRA between the 1st January 2019 to the 12th July 2022.  Please be advised, this figure comprises incidents reported due to a wide range of circumstances, and therefore may not be directly related or similar to your case. For example, a large portion of these incidents received are part of larger multi-faceted literature studies, for which bone cement may not be a contributory factor for the adverse incident.

If you are able to confirm further details of your case, we can provide the number of similar incidents reported to the MHRA. Please note we are unable to provide information on specific manufacturers, makes or models in most cases. We can provide information about generic types of devices.

With regards to the above, the data must be read with the following explanations:

• ·         The majority of reports indicate an issue experienced by a single user. However, some cases may represent the same user experiencing further issues.
• ·         Reports do not necessarily represent an individual patient. Individuals may report an incident at any time after the event and as such can make multiple reports at any time after an incident and on the same issue. Where possible, multiple reports for the same event are linked. However, as reporters are not required to complete all fields, we cannot always be sure enough to link every duplicate.
• ·         It should be noted that this information may include a range of recognised complications related to this type of procedure and does not necessarily indicate a fault with any particular device.
• ·         The numbers include reports where the incident has been taken from published literature.
• ·         These numbers of reports are accurate at the time they are extracted from our database and minor changes in the numbers can occur if the reporter of the incident gives us more details later.
• ·         Adverse incident reports by members of the public are voluntary but play a substantial part in the successful operation of the vigilance system. All reports received via Yellow Card are sent to the relevant manufacturer (if known and anonymised as appropriate) to feed into the vigilance system.
• ·         Adverse incident reports include mandatory reporting by manufacturers to MHRA for certain types of incidents that occurred in the UK as part of the regulatory post market surveillance ‘vigilance’ system. The principal purpose of this system is to improve the protection of health and safety of patients. This is to be achieved by the evaluation of reported AIRs and, where appropriate, dissemination of information, which could be used to prevent such repetitions, or to alleviate the consequences of such adverse events.

Please be assured that with all medical devices, MHRA continues to monitor the safety and performance and encourages reporting of any adverse incidents through the Yellow Card scheme as detailed above. We undertake regular and structured analysis of data received from a large variation of sources which aim to highlight any safety issues that arise. Any emerging evidence relating to possible risks associated with these devices will be carefully reviewed and, if appropriate, regulatory action will be taken if any serious risks were confirmed.

If you have a query about the information provided, please reply to this email. If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: [email protected].

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

Yours sincerely,

Devices Safety & Surveillance Group

Medicines & Healthcare Products Regulatory Agency

10 South Colonnade, Canary Wharf, London, E14 4PU