Increased risks identified with Profemur cobalt chrome modular neck hip replacements
Source: gov.uk (2025-09-03)

Patients implanted with affected devices should expect to be contacted directly for a follow-up assessment, if required.

People with affected hip replacements should expect to be contacted by their hospital for a clinical assessment following a review by the Medicines and Healthcare products Regulatory Agency (MHRA) which found increased safety risks for patients with specific Profemur cobalt chrome modular neck hip replacements. These are:

All hip replacement constructs using Profemur cobalt chrome (CoCr) modular neck components;

All Profemur Xm hip replacement stems (cobalt chrome) used with Profemur titanium or cobalt chrome modular neck components.

While most patients implanted with these hip replacements experience good outcomes and are unlikely to develop serious problems, a small number may be affected by soft tissue reactions or other metal-wear effects, which could lead to the need for revision surgery.

UK trusts and hospitals are being advised to identify and contact patients implanted with affected devices to offer them a follow-up assessment as soon as practically possible, based on their individual risk level. Patients do not need to contact their surgeon or hospital directly.

This advice does not apply to all Profemur branded products, as the brand covers a wide range of products.

The affected devices were used in the UK from 2009 until January 2025 and the available data suggests approximately 2,000 patients currently have these particular hip replacements implanted. These devices are no longer available in the UK.

For context, more than 100,000 hip replacements of all types are performed in the UK each year.

Dr Alison Cave, MHRA Chief Safety Officer, said:

“Our review identified higher than expected risks associated with Profemur cobalt chrome modular neck hip replacements.

“We have developed specific follow-up advice to help ensure patients with these devices receive appropriate care. If you have an affected hip replacement device implanted, you should expect to be contacted by your surgeon or implanting hospital. You don’t need to contact them directly.

“Anyone experiencing new or unexpected symptoms related to any implant should speak to their surgeon or the hospital where their surgery was performed. Please report it to the MHRA via the Yellow Card scheme or the Incident Reporting & Investigation Centre if you are in Scotland.”

For more information, visit: Profemur Cobalt Chrome Modular Neck Hip Replacements (DSI/2025/005) (https://www.gov.uk/drug-device-alerts/profemur-cobalt-chrome-modular-neck-hip-replacements-higher-than-anticipated-risk-of-revision-surgery-metal-wear-effects-and-component-fracture-dsi-slash-2025-slash-005).

Notes to editors

The MHRA review found that the affected devices carry a higher risk of wear, corrosion, and fracture – impacting around 6 in every 1,000 patients, compared to fewer than 1 in 10,000 with alternative hip replacement designs.

This advice does not apply to all Profemur branded products, as the brand covers a wide range of products. Only the product codes included in the DSI (https://www.gov.uk/drug-device-alerts/profemur-cobalt-chrome-modular-neck-hip-replacements-higher-than-anticipated-risk-of-revision-surgery-metal-wear-effects-and-component-fracture-dsi-slash-2025-slash-005) are affected.

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All work is underpinned by robust and fact-based judgements to ensure that benefits justify any risks.

The MHRA is an executive agency of the Department of Health and Social Care.

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