DePuy Synthes Radial Head elbow prosthesis system: risk of post-operative loosening of the radial stem
Manufactured by Synthes GmbH - Recall of Radial Head Prosthesis System. Associated Radial Head Prosthesis system parts also need to be returned to DePuy Synthes but will be available for revision surgeries of the radial head component.
Action
- Do not implant these devices (see details below).
- Locate and return all affected products to DePuy Synthes as detailed in their Field Safety Notice.
- Identify and advise all patients implanted with affected devices to contact their orthopaedic surgeon if they develop symptoms such as pain, loss of function or instability.
- Consider monitoring patients at 6 monthly intervals for up to 2 years post-implantation, with both clinical and radiographic assessments (i.e. X-rays[footnote 1]) to identify possible loosening of the radial stem.
- Any asymptomatic patients identified with loosening of their implants should continue to be monitored at 6-monthly intervals for progressive osteolysis (including potential risk of fracture), or the development of symptoms needing revision surgery.
- Report all adverse events involving this device to DePuy Synthes and to MHRA or the appropriate Devolved Administration.
Action by
- Medical directors
- Orthopaedic departments
- Orthopaedic surgeons
- Staff involved in the management of patients with joint related implants
Deadlines for actions
Actions underway: 19 June 2017
Actions complete: 3 July 2017
NOTE: These deadlines are for systems to be in place to take actions and not for the completion of patient follow up and imaging.
Device details
All lots of the DePuy-Synthes Radial Head prosthesis system are affected.
For part number and description information for the device and associated parts refer to Attachment 1 of the manufacturer’s [Field Safety Notice](https://mhra-gov.filecamp.com/s/vqq2EChzcATElIz0/d/fzGfPW7KjhpXkdsX and the spreadsheet attached to this alert, which includes both catalogue numbers and relevant UDI Device Identifier codes (GS1 GTINs).
Problem / background
In December 2016, DePuy-Synthes issued a Field Safety Notice informing clinicians of the recall of the Radial Head prosthesis due to the possibility of post-operative loosening of the stem at the stem-bone interface. Implant loosening may lead to osteolysis, poor joint mechanics, bone fracture or soft tissue damage.
The radial stem was introduced into the UK market in 2015 and up to the publication date of this medical device alert, MHRA has received no reports of stem loosening.
Manufacturer contacts
Martyn Kedie
Johnson & Johnson Medical Ltd
DePuy Synthes
Leeds One
St Anthony’s Road
Leeds, LS11 8DT
Telephone: 0113 387 6261
Email: MDFieldActionsUKIrl@its.jnj.com
Distribution
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts (NHS boards in Scotland)
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
- Fracture clinics
- Orthopaedic surgeons
- Outpatient clinics
- Physiotherapists
- Purchasing managers
- Radiology departments
- Radiology directors
- Risk managers
- Supplies managers
- Theatre managers
- Theatre nurses
- Theatres
Public Health England
Directors for onward distribution to:
- Collaborating centres
- Consultants in communicable disease control
- Divisional directors
- Heads of department
- Heads of health, safety and quality
- Health protection nurses
NHS England area teams
CAS liaison officers for onward distribution to all relevant staff including:
- General practice managers
- General practice nurses
- General practitioners
Independent distribution
Establishments registered with the Care Quality Commission (CQC) (England only)
- Adult placement
- Hospitals in the independent sector
- Independent treatment centres
- Private medical practitioners
Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: safetyalerts@dh.gsi.gov.uk and requesting this facility.
Enquiries
England
Send enquiries about this notice to MHRA, quoting reference number MDA/2017/016 or 2017/001/005/299/001.
Technical aspects
Salman Ghani or Bayode Adisa, MHRA
Tel: 020 3080 6920 or 020 3080 7723
Email: salman.ghani@mhra.gov.uk or bayode.adisa@mhra.gov.uk
Clinical aspects
Mark Grumbridge, MHRA
Tel: 020 3080 7128
Email: DCT@mhra.gov.uk
Reporting adverse incidents in England
Northern Ireland
Alerts in Northern Ireland are distributed via the NI SABS system.
Enquiries and adverse incident reports in Northern Ireland should be addressed to:
Northern Ireland Adverse Incident Centre, CMO Group,
Department of Health, Social Services and Public Safety
Tel: 028 9052 3868
Email: niaic@health-ni.gov.uk
Northern Ireland Adverse Incident Centre (NIAIC)
Please report directly to NIAIC using the forms on our website.
Scotland
Enquiries and adverse incident reports in Scotland should be addressed to:
Incident Reporting and Investigation Centre,
Health Facilities Scotland,
NHS National Services Scotland
Tel: 0131 275 7575
Fax: 0131 314 0722
Email: nss.iric@nhs.net
Reporting adverse incidents in Scotland
NHS Boards and Local Authorities in Scotland – report to Health Facilities Scotland.
Contractors such as private hospitals carrying out NHS work and private care homes that accept social work funded clients – report to Health Facilities Scotland.
Private facilities providing care to private clients report to the Care Inspectorate and MHRA.
Wales
Enquiries in Wales should be addressed to:
Healthcare Quality Division,
Welsh Government
Tel: 02920 823 624 / 02920 825 510
Email: Haz-Aic@wales.gsi.gov.uk
Reporting adverse incidents in Wales
Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).
Download documents
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In all cases, the benefit of ionising radiation screening should be weighed against the risks from radiation exposure on an individual basis, in line with the requirements of The Ionising Radiation (Medical Exposure) Regulations 2000. ↩