In response to on-going monitoring of the performance of metal-on-metal (MoM) hip joint articulations the MHRA published an updated Medical Device Alert on 29 June 2017 in respect of all MoM hip replacements. It is the first time the Agency has updated its recommendations for all MoM hip devices since June 2012.
The Alert requires all NHS Trusts to put updated systems in place for follow-up and investigation of patients with MoM hip replacements, extending the recommendations for frequent follow-up after primary surgery to asymptomatic patients for the first time, rather than deferring to local protocols, and recommending all patients, regardless of symptoms, undergo blood metal level testing. The Alert is aimed specifically at assisting with early detection of soft tissue reactions in patients with MoM hip replacements (including resurfacing).
The MHRA’s clinical orthopaedic experts have reported that soft tissue necrosis may occur in both asymptomatic and symptomatic patients, and say early detection of these events should improve patient outcomes following revision surgery, should this becomes necessary.
It is also recommended that MARS MRI scans or ultrasound scans should carry more weight in the decision-making in respect of revision surgery than isolated blood metal levels alone. Emphasis is also now placed on capturing data through an Oxford Hip score assessment and considering the need for revision should that score deteriorate.
This latest Alert replaces the patient follow-up advice previously given in MDA/2012/036 (All MoM hip replacements), MDA/2013/010 (Adept 12/14 Modular head), and MDA/2015/024 (Birmingham Hip Resurfacing system).
The Alert requires Trusts to take action to implement the revised follow-up and investigation arrangement by 13 July 2017 and have those systems in place by 27 July 2017.
All NHS Trusts need to urgently ensure they have robust systems in place to identify patients who have undergone MoM hip replacement or resurfacing to ensure they are kept under review.
The trial in the DePuy Pinnacle and Corin Cornet MoM hip litigation will start on 9 October 2017. The trial will consider defect and causation against the manufacturers of those MoM hip devices.