Zimmer Biomet, specific hip and trauma instruments: risk of infection

Manufactured by Zimmer GmbH – recall due to risk of infection as affected instruments may not be adequately cleaned when using standard cleaning instructions (MDA/2018/007).

Action

  • Quarantine affected devices and obtain replacements from the manufacturer.
  • Refer to the manufacturer’s Field Safety Notice (ref ZFA2017-332) for a full list of affected devices.
  • Report all adverse events involving these devices to Zimmer Biomet and the MHRA or the appropriate Devolved Administration.

Action by

  • Medical directors
  • Orthopaedic departments
  • Orthopaedic and trauma surgeons
  • Decontamination and sterilisation departments

Deadlines for actions

Actions underway: 01 March 2018

Actions complete: 15 March 2018

Note: These deadlines are for users to have an action plan in place and not for the repairs to be complete.

Medical Device Safety Officers (in England): ask the manufacturer to add you to their distribution list for field safety notices (FSNs). This is to help with reconciliation.

Remember: if your organisation receives an FSN from a manufacturer, always act on it. Do not wait for a communication from MHRA.

Problem background

The affected devices are being recalled by the manufacturer and replaced with alternative instruments which are already available and can be adequately cleaned using standard cleaning instructions.

This Medical Device Alert is being issued to ensure adequate awareness of the issue and appropriate action is taken.

Manufacturer contacts

Anne-Catherine Morancy Meister
Zimmer GmbH
Sulzer Allee 8
Winterthur
8404
Switzerland
Tel: +41 58 854 82 37
<fieldaction.uk@zimmerbiomet.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 NICAS liaison officers for onward distribution to all relevant staff including:

  • Infection control & prevention directors
  • Infection control departments
  • Infection control nurses
  • MDSOs
  • Microbiologists
  • Operating department practitioners
  • Operating theatres managers
  • Orthopaedic surgeons
  • Sterile services departments

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/2018/007 or 2017/010/003/701/010.

Technical aspects

Jacques Pouget, MHRA
Tel: 020 3080 6143

jacques.pouget@mhra.gov.uk

Clinical aspects

Devices Clinical Team, MHRA
Tel: 020 3080 7274

dct@mhra.gov.uk

Reporting adverse incidents in England

Through Yellow Card

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

MDA/2018/007

Published 15 February 2018