MHRA published Device Safety Information notice DSI/2026/010 on 26 August 2026, warning that cobalt-chrome dual-taper modular-neck hip replacement systems from five manufacturers carry an increased risk of wear and corrosion at their modular junctions — and, with it, a higher risk of needing revision surgery. The devices were sold in the UK between 2007 and 2019; MHRA estimates about 750 patients still carry one, and is directing NHS trusts to find every one of them and bring them in for a clinical review.
What the review found
The devices in question are dual-taper modular-neck hip systems — designs that separate the femoral stem, neck, and head into distinct modular components joined at two tapered junctions rather than manufacturing them as one piece. That modularity lets a surgeon fine-tune leg length and offset intraoperatively, but it also creates two metal-on-metal contact points where micromotion, fretting, and crevice corrosion can degrade the implant over years of use. MHRA's review found an increased risk of wear and corrosion specifically at those two interfaces — the neck-to-stem junction and the neck-to-head junction — in cobalt-chrome versions of five manufacturers' systems, and a corresponding increase in the risk that a patient will eventually need revision surgery. The notice states MHRA did not find evidence of a higher-than-expected rate of outright device fracture, which is the narrower, more acute failure mode regulators have flagged in similar modular-hip reviews elsewhere.
A second class-wide review in two years
DSI/2026/010 did not originate from nothing. MHRA opened this broader review after an earlier alert, DSI/2025/005, covering MicroPort Orthopedics' Profemur modular-neck systems — a similar design that triggered its own wear, corrosion, and fracture concerns and led MicroPort to withdraw its cobalt-chrome and titanium modular-neck Profemur components from the UK market. Rather than treat each dual-taper design as an isolated case, MHRA appears to be working through the modular-neck hip category as a class: the Profemur alert flagged the mechanism, and this review extends the same scrutiny to five more manufacturers' cobalt-chrome systems sold across the same general era. For device makers with legacy dual-taper designs still in the field — cobalt-chrome or otherwise — that pattern is the signal to reassess proactively rather than wait for a name-specific notice.
What NHS trusts are asked to do
- Identify every patient who received one of the five named devices between 2007 and 2019, using implant records and patient registries.
- Invite each one for clinical review — a symptom and functional assessment as the baseline step.
- Escalate where indicated: whole-blood cobalt and chromium ion testing, and cross-sectional imaging such as MARS-MRI or ultrasound, for patients whose review raises concern.
- Consider revision surgery on the evidence — abnormal imaging, elevated or rising metal-ion levels, or clinical deterioration — rather than as a blanket response to having one of the affected implants.
Frequently asked questions
What did MHRA publish, and when?
Device Safety Information notice DSI/2026/010, published 26 August 2026 on GOV.UK's drug and device alerts service, covering cobalt-chrome dual-taper modular-neck hip replacement systems.
Which devices and manufacturers are covered?
Five modular-neck hip systems sold in the UK between 2007 and 2019: Aesculap AG's Metha modular, LimaCorporate's H-Max-M (LimaCorporate is now part of Enovis Corp), Smith & Nephew's SMF, Stryker's ABG II modular, and Symbios's HARMONY modular and SPS modular.
What did MHRA find?
Increased risk of wear and corrosion at the two modular interfaces in these dual-taper designs — the neck-to-stem and neck-to-head junctions — and an associated increase in revision-surgery risk. MHRA said it did not find evidence of a higher-than-expected rate of device fracture.
What are NHS trusts told to do?
Identify all patients who received one of the affected devices and invite them for clinical review — a symptom and functional assessment, and, where clinically indicated, whole-blood cobalt and chromium ion testing and cross-sectional imaging such as MARS-MRI or ultrasound. Revision surgery is to be considered based on the findings, not carried out automatically. MHRA estimates roughly 750 UK patients currently have one of these implants in place.
Sources & further reading
- MHRA / GOV.UK, “Increased risk of wear and corrosion identified with certain cobalt chrome modular neck hip replacements,” news release, 26 August 2026. gov.uk
- MHRA, Device Safety Information notice DSI/2026/010, “Cobalt chrome modular neck hip replacements: risk of metal wear effects and revision surgery.” patient.info
- Nursing in Practice, “Patients with certain hip replacement to be invited for clinical review after risk identified,” 26 August 2026. nursinginpractice.com
- Medscape, “Corrosion Alert for Cobalt Chrome Hip Replacements.” medscape.com
Regulatory News reports on public regulatory documents. It is not legal advice, and the primary sources above govern. If we have made an error, we will say so in public: see corrections.