Bone Cement: Optipac 40 Refobacin Revision and Optipac 80 Refobacin Revision – Risk of revision

Manufactured by Biomet – risk of revision surgery from an increase in bone cement polymerisation time and reduced mechanical strength.

Action

  • Identify and quarantine all affected devices. (See table below for affected batches.)
  • Follow actions recommended in the manufacturer’s Field Safety Notice.
  • If at time of use the setting time was longer than indicated in the manufacturer’s instructions for use these patients may require more frequent follow up.
  • For all affected patients, surgeons will need to formulate a local risk assessment and follow-up plan based upon the length of time the device was in storage and relevant patient variables. The affected batches are known to have their mechanical strength reduced by half after 6 months in storage.
  • Complete the certificate of acknowledgment attached to the Field Safety Notice and return it to the manufacturer.

Action by

All users of the affected medical device.

Deadlines for actions

Actions underway: 30 April 2018

Actions complete: 14 May 2018

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.

Device details

Catalogue number (Manufacturer product code) Product Description Batch/Lot number Use-by date Date of manufacture
OPTIPAC 40 REFOBACIN REVISION 4730501163-1 A648C04670 31/05/2018 19/12/2016
OPTIPAC 40 REFOBACIN REVISION 4730501163-1 A648C05100 30/06/2018 09/01/2017
OPTIPAC 40 REFOBACIN REVISION 4730501163-1 A705B05130 31/07/2018 09/02/2017
OPTIPAC 40 REFOBACIN REVISION 4730501163-1 A705B06130 30/09/2018 04/04/2017
OPTIPAC 40 REFOBACIN REVISION 4730501163-1 A722B08920 30/11/2018 20/06/2017
OPTIPAC 80 REFOBACIN REVISION 4732501165-1 A620A01788 31/01/2018 16/08/2016
OPTIPAC 80 REFOBACIN REVISION 4732501165-1 A620A0178A 31/01/2018 23/08/2016
OPTIPAC 80 REFOBACIN REVISION 4732501165-1 A705C05628 31/08/2018 30/03/2017
OPTIPAC 80 REFOBACIN REVISION 4732501165-1 B705B05128 31/07/2018 09/02/2017

Problem / background

In December 2017 Biomet issued a Field Safety Notice informing healthcare professionals that the mechanical strength of the affected batches of bone cement may be reduced increasing the risk of revision. There is also a risk of prolonged surgery from increased polymerisation time when using affected batches of bone cement. The manufacturer suggests it would be prudent to monitor closely affected patients as part of their standard follow-up.

This Medical Device Alert is being issued to ensure that all hospitals are aware of the issue and that adequate action is taken to mitigate potential risk to patients.

Manufacturer contacts

Zimmer Biomet UK Ltd
Peter Bevan
Email: Peter.Bevan@zimmerbiomet.com

Tel: +441656674270 Mobile: +447920007446

Peter.Bevan@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:

  • Day surgery units
  • Equipment stores
  • Equipment libraries and stores
  • Medical directors
  • Operating department practitioners
  • Orthopaedic surgeons
  • Risk managers
  • Sterile services departments
  • Supplies managers
  • Theatre managers
  • Theatre nurses
  • Theatres

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)

  • Hospitals in the independent sector
  • Independent treatment centres

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/2018/011 or [2017/012/019/071/001].

Technical aspects

Hasan Samee-Ahmed MHRA

Tel: 020 3080 6807

Email: hasan.samee-ahmed@mhra.gov.uk

Clinical aspects

Devices Clinical Team, MHRA

Tel: 020 3080 7274

Email: DCT@mhra.gov.uk

Reporting adverse incidents in England

Through Yellow Card

Northern Ireland

Alerts in Northern Ireland are distributed via the NICAS 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

https://www.health-ni.gov.uk/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

Bone Cement: Optipac 40 Refobacin Revision and Optipac 80 Refobacin Revision – Risk of revision

Published 20 April 2018