Device safety informationMHRA
Cobalt-chrome modular neck hip replacements safety warning over risk of metal-wear effects and revision surgery
An MHRA investigation has found increased risks of wear and corrosion associated with multiple cobalt-chrome (Co-Cr) modular neck hip stem components, including a potential increased occurrence of revision surgery due to adverse local tissue reaction (ALTR).
What to do now
Cobalt-chrome modular neck hip replacements may show incorrect information or fail to alert as expected.
- Speak to the clinic, hospital or supplier who gave you the device before changing how you use it.
- Check the model, lot or serial number against the details on this page.
- Any incident involving the device can be reported through the Yellow Card scheme.
Why it matters. Software faults can lead to wrong readings, missed alarms or incorrect settings.
Replacements and support
Speak to the supplier, clinic or hospital that gave you the device. They will know whether yours is affected and what happens next.
Do not throw away a device you rely on until a replacement has been arranged.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (DSI/2026/010). Quoted as issued.
Summary
An MHRA investigation has found increased risks of wear and corrosion associated with multiple cobalt-chrome (Co-Cr) modular neck hip stem components, including a potential increased occurrence of revision surgery due to adverse local tissue reaction (ALTR).
The risk
Summary An MHRA investigation has found increased risks of wear and corrosion associated with multiple cobalt-chrome (Co-Cr) modular neck hip stem components, including a potential increased occurrence of revision surgery due to adverse local tissue reaction (ALTR). There is a potential increased risk of wear and corrosion associated with the presence of two interfaces on the dual taper modular neck: one between the modular neck and the modular hip stem, and another between the modular neck and modular head. MHRA recommends that patients implanted with affected devices should be invited for a virtual or face-to-face clinical review to inform them of the potential risks, assess their clinical presentation and discuss the need for continued follow-up. Two of the systems in scope of this DSI (ABG II modular and SMF) have already been the subject of previous investigations by the manufacturers. Patients implanted with these devices may not need further follow-up if they are already undergoing monitoring based on the manufacturers’ previous recommendations.
Advice for healthcare professionals
An MHRA investigation has found increased risks of wear and corrosion associated with multiple cobalt-chrome (Co-Cr) modular neck hip stem components, including a potential increased occurrence of revision surgery due to adverse local tissue reaction (ALTR). There is a potential increased risk of wear and corrosion associated with the presence of two interfaces on the dual taper modular neck: one between the modular neck and the modular hip stem, and another between the modular neck and modular head. MHRA recommends that patients implanted with affected devices should be invited for a virtual or face-to-face clinical review to inform them of the potential risks, assess their clinical presentation and discuss the need for continued follow-up.
Two of the systems in scope of this DSI (ABG II modular and SMF) have already been the subject of previous investigations by the manufacturers. Patients implanted with these devices may not need further follow-up if they are already undergoing monitoring based on the manufacturers’ previous recommendations.
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
all identified patients should be informed of the risks detailed in this Device Safety Information communication
if symptoms or clinical findings suggest an adverse soft tissue reaction or other metal-related effects, the following follow-up is recommended:
perform a whole blood test for cobalt and chromium* using a laboratory associated with one of the following schemes:
in England, Northern Ireland, or Wales: laboratories participating in the UK National External Quality Assessment Service (UK NEQAS)
in Scotland: the Scottish Trace Element and Micronutrient Reference Laboratories
conduct cross-sectional imaging using MARS MRI or ultrasound, depending on local trust or hospital policy
each patient should be assessed on an individual basis
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. Please refer to Table 1 and discuss the row for the implant system that is relevant to the patient
patients with affected devices, who have not already been contacted, should expect to be contacted by their surgeon or implanting hospital and invited for a clinical assessment to consider and discuss whether any action is recommended. 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
none of the implant systems investigated showed a higher-than-expected revision rate due to device fracture
Open the MHRA notice
Questions
Why has Cobalt-chrome modular neck hip replacements been recalled?
Cobalt-chrome modular neck hip replacements may show incorrect information or fail to alert as expected. Software faults can lead to wrong readings, missed alarms or incorrect settings.
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?
Speak to the clinic, hospital or supplier who gave you the device before changing how you use it. Check the model, lot or serial number against the details on this page.
Who replaces the device?
Speak to the supplier, clinic or hospital that gave you the device. They will know whether yours is affected and what happens next. Do not throw away a device you rely on until a replacement has been arranged.