Device Safety Information – DSI/2025/005
Published on 04 September 2025
From: NHSScotland Assure
DSI/2025/005 - Profemur Cobalt Chrome Modular Neck Hip Replacements: Higher risk of revision surgery, metal-wear effects and component fracture.
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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.
Patients implanted with affected Profemur devices are to be invited for a clinical review to inform them of the identified risks, assess their clinical presentation and discuss the need for continued follow-up.