Shoulder system: Comprehensive Nano Humeral Components – increased risk of revision when used in reverse configuration
Manufactured by Zimmer Biomet – do not use this device in the reverse configuration. (MDA/2017/023)
Action
- Immediately stop using the affected items in the reverse configuration.
- Read the manufacturer’s Field Safety Notice for further information.
- Complete the certificate of acknowledgment attached to the Field Safety Notice and return it to the manufacturer.
- Monitor patients who have already been implanted with this device in the reverse configuration for signs of loosening on X-ray[footnote 1] for 2 years post-implantation.
- Advise patients to contact their implanting centre if they experience any increased pain or loss of shoulder movement or if their shoulder suddenly changes shape.
- Report all adverse events involving this device to Zimmer Biomet and to MHRA or the appropriate Devolved Administration.
Action by
All users of the affected medical devices.
Deadlines for actions
Actions underway: 04 September 2017 Actions complete: 18 September 2017
Device details
The following components are affected:
| Device Identifier | Item Number | Product Description | Size | NHS Supply Codes |
|---|---|---|---|---|
| (01)00880304530898 | 115730 | Comprehensive Nano Humeral Component PPS | 30mm | FQS196 |
| (01)00880304530904 | 115732 | Comprehensive Nano Humeral Component PPS | 32mm | FQS197 |
| (01)00880304530881 | 115734 | Comprehensive Nano Humeral Component PPS | 34mm | FQS198 |
| (01)00880304530935 | 115736 | Comprehensive Nano Humeral Component PPS | 36mm | FQS199 |
| (01)00880304530911 | 115738 | Comprehensive Nano Humeral Component PPS | 38mm | FQS200 |
| (01)00880304530928 | 115740 | Comprehensive Nano Humeral Component PPS | 40mm | FQS201 |
Problem / background
Data collected by the manufacturer indicates that the Comprehensive Nano Humeral Component did not meet the expected performance rate (EPR) when used in the reverse configuration. Therefore, the manufacturer has changed the indication for use and it must no longer be used in the reverse configuration. The component may still be used in the anatomic configuration.
MHRA is issuing this advice to ensure that you are aware of the change in indication for use and take appropriate action.
Manufacturer contacts
Zimmer Biomet
Mr Grayham Burnell,
Corrective Action Co-ordinator,
Complaints Department,
UK
Tel: 01656 678 308 [email protected]
If you haven’t yet returned the certificate of acknowledgement form attached to the Field Safety Notice, please contact Mr Grayham Burnell.
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:
- Orthopaedic surgeons
- Supplies managers
- Theatre managers
Independent distribution
Establishments registered with the Care Quality Commission (CQC) (England only)
- 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: [email protected] and requesting this facility.
Enquiries
England
Send enquiries about this notice to MHRA, quoting reference number MDA/2017/023 or 2017/006/007/291/011.
Technical aspects
Alan McDonagh or Hasan Samee-Ahmed, Medical Device Specialists, MHRA
Tel: 020 3080 6268 / 6807
[email protected] [email protected]
Clinical aspects
Dr Kate Antrobus, Clinical Advisor, Devices Clinical Team, MHRA
Tel: 020 3080 7274
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: [email protected]
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: [email protected]
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: [email protected]
Reporting adverse incidents in Wales
Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).
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