Get Medical Device Adverse Incident Report Form Hip Or Knee Implants - Mhra Gov

Filling out the Medical Device Adverse Incident Report Form for hip or knee implants is essential for reporting adverse incidents related to these medical devices. This guide will provide step-by-step instructions to help you accurately complete this form online.

Follow the steps to fill out the form correctly.

1. Press the ‘Get Form’ button to access the form and open it in your preferred online editor.
2. Begin by entering the reporter details. Fill in your name, organisation, address, telephone number, e-mail, and the consultant-in-charge if known. Additionally, include the local reference number.
3. Indicate how the report is being submitted by selecting one of the options: a telephone report, a fax report, or neither.
4. In the 'Type of injury' section, specify the nature of the injury by selecting the most applicable option such as fatality, serious, revision, distress, minor, or none.
5. Enter patient information. Provide the patient's identification code, gender, date of birth, implant type (hip or knee), date of primary implantation, and implant side (left or right).
6. For 'Indication for primary implantation,' select the reason from the provided list, including conditions such as avascular necrosis, rheumatoid arthritis, congenital dysplasia, among others.
7. Complete the 'Failed component' section by indicating the specific hip or knee components that have failed, from the choices listed.
8. State the reason for the revision in the next section, choosing from options such as loosening, wear, infection, etc. Specify if applicable.
9. Follow the instructions regarding the retrieval of implants and any discussions to have with MHRA’s Adverse Incident Centre.
10. Fill in the revision details, including the date of revision and the hospitals where both primary and revision operations occurred.
11. Provide retrieved prosthesis information, including manufacturer details, model name, and other required identifiers.
12. Indicate the cement type used. If it is an 'other' option, specify the type.
13. Answer if radiographs are available from the initial implantation by selecting yes or no.
14. Enter the current location of the explanted device and add any relevant comments in the space provided or on a separate sheet.
15. Complete the report by adding the date of completion and then return the form via e-mail, fax, or postal address as provided.

Complete and submit the Medical Device Adverse Incident Report Form online today to ensure adverse incidents are properly documented and addressed.