Device safety informationMHRA
Profemur Cobalt Chrome Modular Neck Hip Replacements safety warning over a malfunction
An MHRA investigation has found increased risks of wear and corrosion, including an increased occurrence of device fracture and revision surgery associated with cobalt chrome-containing Profemur modular neck hip stem components.
What to do now
The MHRA has warned about a fault with Profemur Cobalt Chrome Modular Neck Hip Replacements.
- If you use this device at home, do not stop treatment without speaking to the team who supplied it.
- Compare the details on the device or its box with the list here.
- Report problems with medical devices to the MHRA Yellow Card scheme.
Why it matters. A device that fails at the wrong moment can delay treatment or cause injury.
Replacements and support
Device safety notices are mainly aimed at hospitals, clinics and suppliers, who are told how to replace, update or check affected devices.
If you use the device at home, the team or company that supplied it is responsible for any replacement or correction.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (DSI/2025/005). Quoted as issued.
Summary
An MHRA investigation has found increased risks of wear and corrosion, including an increased occurrence of device fracture and revision surgery associated with cobalt chrome-containing Profemur modular neck hip stem components.
The risk
Summary An MHRA investigation has found increased risks of wear and corrosion, including an increased occurrence of device fracture and revision surgery associated with cobalt chrome-containing Profemur modular neck hip stem components. Patients implanted with affected Profemur devices are to be invited for a clinical review to inform them of the identified risks, assess their clinical presentation and discuss the need for continued follow-up. Advice for healthcare professionals:
Advice for healthcare professionals
An MHRA investigation has found increased risks of wear and corrosion, including an increased occurrence of device fracture and revision surgery associated with cobalt chrome-containing Profemur modular neck hip stem components. Patients implanted with affected Profemur devices are to be invited for a clinical review to inform them of the identified risks, assess their clinical presentation and discuss the need for continued follow-up.
Clinical Follow-up Recommendation:
trusts / hospitals should review local and national databases (e.g. the National Joint Registry) to identify patients implanted with the specified devices
all identified patients should be contacted and invited to attend a virtual or face-to-face clinical review under the prioritised conditions recommended in Table 1
Table 1. Recommended risk prioritisation groupings for patients implanted with affected devices.
Risk Grouping*
Highest Risk Group
Moderate Risk Group
Lower Risk Group
Priority Condition
All patients to be invited for clinical review as soon as practically possible.
All patients to be invited for clinical review as soon as practically possible. Priority is to be given to patients in the Highest Risk Group.
Advice for patients
the majority of patients implanted with these hip replacements have well-functioning hips and are thought to be at a low risk of developing serious problems
a small number of patients implanted with these hips may, however, develop soft tissue reactions or other metal-related effects resulting in the need for revision surgery
patients with affected devices should expect to be contacted and, if in the highest or moderate patient risk groups, be invited for a clinical assessment to consider and discuss whether any action is required. Patients in the lowest risk group will be invited only if they are concerned or are symptomatic
patients who have an affected hip replacement device implanted, should expect to be contacted by their surgeon or implanting hospital. There is no need for patients to contact their surgeon or implanting hospital directly.
in the meantime, if patients experience any new or unexpected symptoms including pain, stiffness, or instability, they should speak to their implanting surgeon or the hospital where their surgery was performed in the first instance
Open the MHRA notice
Questions
Why has Profemur Cobalt Chrome Modular Neck Hip Replacements been recalled?
The MHRA has warned about a fault with Profemur Cobalt Chrome Modular Neck Hip Replacements. A device that fails at the wrong moment can delay treatment or cause injury.
How do I know if my product is affected?
The notice describes the affected product rather than listing codes. Compare the product name, pack size and where you bought it with the official notice.
What should I do now?
If you use this device at home, do not stop treatment without speaking to the team who supplied it. Compare the details on the device or its box with the list here.
Who replaces the device?
Device safety notices are mainly aimed at hospitals, clinics and suppliers, who are told how to replace, update or check affected devices. If you use the device at home, the team or company that supplied it is responsible for any replacement or correction.