MHRA warns thousands over risk of fracture from certain hip replacements

The Medicines and Healthcare products Regulatory Agency (MHRA) has warned thousands of people in the UK that certain modular-neck hip replacement devices may be at risk of mechanical failure, and has ordered local trusts and hospitals to invite affected patients for clinical review.

The regulator concluded that about 2,000 people who received the common joint operation between 2009 and January 2025 could be affected, and said a small percentage of those could face about a 1 in 100 chance of fracture of the implant. Patients fitted with a Profemur cobalt chrome (CoCr) modular neck hip replacement are being prioritised for review.

Invitations for clinical reviews will be issued by hospitals and NHS trusts in order of assessed risk. The MHRA identified a high-risk group consisting of patients fitted with a recalled CoCr modular-neck product bearing the code PHAC1254. Patients classed as moderate risk include those who received a CoCr neck on either a Profemur or Ancafit titanium alloy stem, or a Profemur Xm CoCr stem; this moderate group also includes some patients whose implant material combinations are not recorded.

Moderate-risk patients are to be seen as soon as possible, the regulator said. Low-risk patients will be offered clinical assessment only if they report symptoms such as pain, instability or loss of function.

The MHRA investigation followed reports of malfunction associated with modular-neck systems. The probe reviewed cases going back to 2009 and up to January 2025 to identify device models and material combinations linked to higher failure rates. The regulator has instructed trusts to trace and contact patients fitted with the specified devices so that a clinical assessment can be arranged.

Hospitals and trusts are responsible for implementing the MHRA's instructions and arranging reviews in line with the stated prioritisation. The reviews are intended to determine whether further monitoring, imaging or intervention is required, based on individual clinical findings.

Patients who have had a hip replacement and are concerned about the type of implant they received should contact their local NHS trust or hospital to enquire about a review and to confirm whether they will be contacted. The MHRA said it would continue to liaise with healthcare providers to ensure that affected patients are identified and offered appropriate clinical assessment.