Medical Device Alert: Knee replacement implant manufactured by DePuy International Limited (MDA/2009/037)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2009/037 or 2008/001/018/291/033

Technical aspects
Dr Elsie Damien or Miss Juliet Aharoni
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ

Tel: 020 7084 3276/3177
Fax: 020 7084 3106

E-mail: elsie.damien@mhra.gsi.gov.uk or juliet.aharoni@mhra.gsi.gov.uk

Clinical aspects
Christopher Brittain
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ

Tel: 020 7084 3126
Fax: 020 7084 3111

E-mail: christopher.brittain@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

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 (NIAIC)
Health Estates
Estate Policy Directorate
Stoney Road
Dundonald
Belfast
BT16 1US

Tel: 02890 523 704
Fax: 02890 523 900

E-mail: 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 https://sabs.dhsspsni.gov.uk

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

E-mail: iric@shs.csa.scot.nhs.uk

http://www.hfs.scot.nhs.uk/online-services/incident-reporting-and-investigation-centre-iric/

Enquiries in Wales should be addressed to:

Dr Jane Ludlow
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3505 / 3922

E-mail: Haz-Aic@wales.gsi.gov.uk

Knee replacement implant. Preservation mobile bearing unicompartmental knee manufactured by DePuy International Limited.

The DePuy Preservation unicompartmental knee system is available in two variants: fixed or mobile bearing.

This alert applies only to the mobile bearing variant that uses the mobile bearing tibial tray and insert. See Appendix for product codes.

The system has been distributed in the UK since 2002.

• Identify patients implanted with affected devices.
• Consider undertaking clinical assessment of affected patients at least annually.

The MHRA has received expert advice that all patients implanted with affected devices should be reviewed routinely in order to ensure that those requiring revision are identified at the earliest opportunity. Where additional radiological examination is required, the benefit should be weighed against the risks from radiation exposure on an individual basis, in line with the requirements of IR(ME)R 20001.

References
1. SI 2000 No 1769. The Ionising Radiation (Medical Exposure) Regulations 2000.

This MDA has been distributed to:

• NHS trusts in England (Chief Executives)
• Healthcare Commission (CHAI) (Headquarters)
• HSC Trusts in Northern Ireland (Chief Executives)
• NHS Boards in Scotland (Chief Executives) 
• Primary care trusts in England (Chief Executives

Onward distribution
Please bring this notice t distribution by:

Trusts to:
CAS and SABS

• Clinical governance leads
• Fracture clinics
• Medical directors
• Nursing executive directors
• Orthopaedic departments
• Orthopaedic surgeons
• Outpatient clinics
• Outpatient theatre managers
• Outpatient theatre nurses
• Physiotherapists
• Radiology departments
• Radiology directors
• Risk managers
• Supplies managers
• Theatre managers

Care Quality Commission (CQC) (England only) to:
Headquarters for onward distribution as appropriate to:

• Hospitals in the independent sector
• Independent treatment centres

Primary care trusts to:
CAS liaison officers for onward distribution to all relevant staff including:

• Community hospitals
• Directors of public health
• Physiotherapists

Change of address or removal from address list for Care Quality Commission:
National Contact Centre
Care Quality Commission
St Nicholas Building
St Nicholas Street
Newcastle-upon-Tyne
NE1 1NB

Tel: 03000 61 61 61

E-mail: enquiries@cqc.org.uk

Paul Arnott
DePuy Internernational Limited 
St Anthony’s Road
Leeds LS11 8DT

Tel: 0113 387 6298
Fax: 0113 387 6087

E-mail: parnott@its.jnj.com

Preservation mobile bearing inserts

Preservation mobile bearing tibial trays