Dear BHS Member,

Over the last few months, members of the Executive of the BHS have been working closely with the Medicine Health and Regulatory Authority (MHRA) and senior representatives from the British Orthopaedic Association (BOA) and the National Joint Registry (NJR) to investigate concerns related to the performance of Profemur Cobalt Chrome modular neck hip replacements. 

These investigations have revealed a higher than anticipated risk of revision surgery, metal-wear effects and component fracture. The MHRA investigation has now concluded and their guidance can be found here.

The recommendations are that all patients who have received these implants should be identified and offered a review appointment and investigation as outlined in the guidance above. While this will undoubtedly raise concern among patients, surgeons and other healthcare providers, it is important that all necessary steps are taken to manage any risk appropriately. 

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
  • consider revision surgery if any of the following are present:
    • abnormal imaging findings
    • blood metal levels that are higher than expected and/or rising
    • deterioration in hip-related clinical function or Patient Reported Outcome Measures (PROMs)
• following this clinical review:
  • symptomatic patients should be followed up annually while the device remains in place
  • asymptomatic patients should be advised to return if they develop new or concerning symptoms

While this device safety information relates to the Profemur Cobalt Chrome femoral implants, the British Hip Society suggests that members carefully consider the use of all modular neck implants in light of the current findings.

If you have any questions, we would recommend contacting the MHRA directly however, I am happy to hear from members who have concerns they would like to discuss so please do not hesitate to contact me at president@britishhipsociety.com.

Very best wishes,

Matt Wilson

President - British Hip Society.