Profemur Cobalt Chrome Modular Neck Hip Replacements: Higher than anticipated risk of revision surgery, metal-wear effects and component fracture

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 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.

The MHRA, with the support of the British Orthopaedic Association (BOA) and the British Hip Society (BHS), has recommended that NHS trusts and provider hospitals should review local and national databases (e.g. the National Joint Registry) to identify patients implanted with the specified devices and all identified patients should be contacted and invited to attend a virtual or face-to-face clinical review under the prioritised conditions. All patients should be invited for clinical review as soon as practically possible if implanted with the recalled CoCr modular neck product code PHAC1254 (Highest Risk Group) or implanted with a CoCr neck on either a Profemur or Ancafit titanium alloy or Profemur Xm CoCr stem – this group includes patients whose implant material combinations are unknown – (Moderate Risk Group). Priority should be give to the Highest Risk Group of patients.

Patients implanted with a titanium alloy neck on a Profemur Xm CoCr stem should be invited for clinical review only if they are concerned or have symptoms such as pain, loss of function or instability (Lowest Risk Group).

All identified patients, regardless of risk grouping, should be informed of the risks provided within the 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
  • 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