MHRA Warning Letter Metal Metal 1

Medical Device Alert
Action
Ref: MDA/2010/033 Issued: 22 April 2010 at 14:00
Device
All metal-on-metal (MoM) hip replacements.
Problem Action
The MHRA has received reports of revisions of
MoM hip replacements involving soft tissue Put systems in place for the follow-up of
reactions. These reactions may be associated patients implanted with MoM hip
with unexplained hip pain. replacements including, where appropriate,
blood metal ion measurements and cross
sectional imaging.
Action by
• Medical directors
• Orthopaedic departments
• Orthopaedic surgeons
• Staff involved in the management of
patients with joint replacement implants.
CAS deadlines
Action underway: 21 May 2010
Action complete: 17 June 2010
Note: These deadlines are for systems to be in

place to take actions and not for the completion
of patient follow-up and testing.
Medicines and Healthcare products Regulatory Agency Page 1 of 4

Issued: 22 April 2010 at 14:00 Ref: MDA/2010/033
Problem
The majority of patients implanted with MoM hip replacements have well functioning hips and are thought to
be at a low risk of developing serious problems.
A small number of patients implanted with these hips may, however, develop progressive soft tissue
reactions to the wear debris associated with MoM articulations. The debris can cause soft tissue necrosis
and adversely affect the results of revision surgery. Early revision of poorly performing MoM hip
replacements should give a better revision outcome.
Following extensive consultation with orthopaedic experts and using information from the National Joint
Registry for England and Wales, the MHRA is issuing this interim advice to healthcare professionals
involved in the management of patients implanted with MoM hip replacements.
The MHRA is continuing to monitor the situation in consultation with orthopaedic experts and may issue
further advice.
Action
For patients implanted with MoM hip replacements:
• follow up patients at least annually for five years postoperatively and more frequently in the
presence of symptoms. Beyond five years, follow up in accordance with locally agreed protocols
• investigate patients with painful MoM hip replacements. Specific tests should include evaluation
of cobalt and chromium ion levels in the patient’s blood and cross sectional imaging including
MRI or ultrasound scan
• consider measuring cobalt and chromium ion levels in the blood and/or cross sectional imaging
for the following patient groups:
> patients with radiological features associated with adverse outcomes including
component position
> patients with small component size (hip resurfacing arthroplasty only)
> cases where the patient or surgeon is concerned about the MoM hip replacement
> cohorts of patients where there is concern about higher than expected rates of failure
• if either cobalt or chromium ion levels are elevated above seven parts per billion (ppb), then a
second test should be performed three months after the first in order to identify patients who
require closer surveillance, which may include cross sectional imaging
• if imaging reveals soft tissue reactions, fluid collections or tissue masses then consider revision
surgery.
Note: Measurements of cobalt or chromium ions should be carried out by laboratories participating in the
Trace Elements External Quality Assessment Scheme (TEQAS) (http://www.sas-centre.org/home.html).
Distribution
This MDA has been distributed to:
• NHS trusts in England (Chief Executives)
• HSC trusts in Northern Ireland (Chief Executives)
• NHS boards in Scotland (Chief Executives)
• NHS boards and trusts in Wales (Chief Executives)
• Care Quality Commission (Headquarters)
• Primary care trusts in England (Chief Executives)

Onward distribution
Please bring this notice to the attention of all who need to know or be aware of it. This may include
distribution by:
Trusts to:
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
• Clinical governance leads
• Medical directors
• Nursing executive directors
• Orthopaedic departments
• Orthopaedic surgeons
• Outpatient clinics
• Outpatient theatre managers
• Outpatient theatre nurses
• Pathologists
• Radiology departments
• Radiology directors
• Risk managers
• Theatre managers
Care Quality Commission (CQC) (England only) to:

The MHRA considers this information to be important to:
• Hospitals in the independent sector
• Independent treatment centres
• Private medical practitioners
Primary care trusts to:

• Directors of public health
• General practitioners
• NHS walk-in centres
England
If you are in England, please send enquiries about this notice to the MHRA, quoting reference number
MDA/2010/033 or 2010/004/019/291/007
Technical aspects
Ms Feza Haque or Dr Crina Cacou or Dr Khalid Razak
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ
Tel: 020 7084 /3066/ 3338/ 3200
Fax: 020 7084 3106
Email: feza.haque@mhra.gsi.gov.uk crina.cacou@mhra.gsi.gov.uk khalid.razak@mhra.gsi.gov.uk
Clinical aspects
Dr Susanne Ludgate
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ
Tel: 020 7084 3123
Fax: 020 7084 3111
Email: susanne.ludgate@mhra.gsi.gov.uk
How to report adverse incidents

Please report via our website http://www.mhra.gov.uk
Further information about CAS can be found at https://www.cas.dh.gov.uk/Home.aspx

Northern Ireland
Alerts in Northern Ireland will continue to be distributed via the NI SABS system.
Enquiries and adverse incident reports in Northern Ireland should be addressed to:
Northern Ireland Adverse Incident Centre
Health Estates Investment Group
Room 17
Annex 6
Castle Buildings
Stormont Estate
Dundonald BT4 3SQ
Tel: 02890 523 704
Fax: 02890 523 900
Email: NIAIC@dhsspsni.gov.uk
http://www.dhsspsni.gov.uk/index/hea/niaic.htm
How to report adverse incidents in Northern Ireland

Please report directly to NIAIC, further information can be found on our website http://www.dhsspsni.gov.uk/niaic
Further information about SABS can be found at http://sabs.dhsspsni.gov.uk/
Scotland
Enquiries and adverse incident reports in Scotland should be addressed to:
Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh EH12 9EB
Tel: 0131 275 7575
Fax: 0131 314 0722
Email: nss.iric@nhs.net
http://www.hfs.scot.nhs.uk/online-services/incident-reporting-and-investigation-centre-iric/
Wales
Enquiries in Wales should be addressed to:
Dr Sara Hayes
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff CF10 3NQ
Tel: 029 2082 3922
Email: Haz-Aic@wales.gsi.gov.uk
MHRA is an executive agency of the Department of Health

© Crown Copyright 2010
Addressees may take copies for distribution within their own organisations

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Medical Device Alert

Ref: MDA/2010/033 Issued: 22 April 2010 at 14:00

All metal-on-metal (MoM) hip replacements.

Note: These deadlines are for systems to be in

Medicines and Healthcare products Regulatory Agency Page 1 of 4

Medicines and Healthcare products Regulatory Agency Page 2 of 4

Care Quality Commission (CQC) (England only) to:

Primary care trusts to:

How to report adverse incidents

Medicines and Healthcare products Regulatory Agency Page 3 of 4

How to report adverse incidents in Northern Ireland

MHRA is an executive agency of the Department of Health

Medicines and Healthcare products Regulatory Agency Page 4 of 4

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