Device safety informationMHRA
CPT Hip System Femoral Stem 12/14 Neck Taper safety warning over a malfunction
Recent research has found that the CPT Hip System Femoral Stem 12/14 Neck Taper, cobalt chromium, (a type of hip implant) carries a higher risk of postoperative periprosthetic femoral fracture (PFF) compared to hips of a similar design but made of a different material. The device will be phased out in the UK by December 2024.
What to do now
The MHRA has warned about a fault with CPT Hip System Femoral Stem 12/14 Neck Taper.
- Speak to the clinic, hospital or supplier who gave you the device before changing how you use it.
- Check the model, lot or serial number against the details on this page.
- Any incident involving the device can be reported through the Yellow Card scheme.
Why it matters. A device that fails at the wrong moment can delay treatment or cause injury.
Replacements and support
Speak to the supplier, clinic or hospital that gave you the device. They will know whether yours is affected and what happens next.
Do not throw away a device you rely on until a replacement has been arranged.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (DSI/2024/007). Quoted as issued.
Summary
Recent research has found that the CPT Hip System Femoral Stem 12/14 Neck Taper, cobalt chromium, (a type of hip implant) carries a higher risk of postoperative periprosthetic femoral fracture (PFF) compared to hips of a similar design but made of a different material. The device will be phased out in the UK by December 2024.
The risk
Devices Details Device Name: CPT Hip System Femoral Stem 12/14 Neck Taper Product Code: Refer to the Field Safety Notice (FSN) issued by the manufacturer for details on the affected devices.
Advice for healthcare professionals
Actions for healthcare professionals (particularly surgeons)
Follow the actions set out in the Field Safety Notice .
Do not use CPT Hip System for elective surgery except in certain circumstances.
The CPT Hip System should only be implanted in new patients when the benefits of implanting the device outweigh the risks. A patient-centered consultation should consider the risks of implanting the affected device alongside the management needs of their condition. This discussion should be documented in the patient’s records.
For situations where it is in the patient’s interest to receive urgent treatment, only use the CPT Hip System when appropriate alternative devices are not available.
There are no specific patient monitoring instructions that are recommended beyond your existing follow-up schedule.
There are specific reporting arrangements for healthcare professionals to follow in each region. Healthcare professionals should report incidents:
in England and Wales to the Yellow Card scheme or via the Yellow Card app
in Scotland to Incident Reporting & Investigation Centre (IRIC) and their local incident recording system
in Northern Ireland to the Northern Ireland Adverse Incident Centre and their local incident recording system
Actions for hospitals
Hospitals with exclusive access or use of the CPT stem should engage with their supply chain management to seek alternative products and arrange suitable training for staff in their use.
Open the MHRA notice
Questions
Why has CPT Hip System Femoral Stem 12/14 Neck Taper been recalled?
The MHRA has warned about a fault with CPT Hip System Femoral Stem 12/14 Neck Taper. A device that fails at the wrong moment can delay treatment or cause injury.
How do I know if my product is affected?
The notice describes the affected product rather than listing codes. Compare the product name, pack size and where you bought it with the official notice.
What should I do now?
Speak to the clinic, hospital or supplier who gave you the device before changing how you use it. Check the model, lot or serial number against the details on this page.
Who replaces the device?
Speak to the supplier, clinic or hospital that gave you the device. They will know whether yours is affected and what happens next. Do not throw away a device you rely on until a replacement has been arranged.