Medical Device Alert: Knee replacement implant manufactured by DePuy International Limited (MDA/2009/062)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2009/062 or 2009/005/014/081/001.

Technical aspects
Miss Juliet Aharoni or Mr Allan Hidderley
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London SW8 5NQ

Tel: 020 7084 3177/3172
Fax: 020 7084 3106

Email: juliet.aharoni@mhra.gsi.gov.uk or allan.hidderley@mhra.gsi.gov.uk

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

Tel: 020 7084 3126
Fax: 020 7084 3111

Email: christopher.brittain@mhra.gsi.gov.uk

How to report adverse incidents
Please report via our website: Reporting adverse incidents involving medical devices.
Further information about CAS can be found on the Central Alerting System website (external link).

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

Email: NIAIC@dhsspsni.gov.uk

Northern Ireland Adverse Incident Centre (NIAIC) (external link)

How to report adverse incidents in Northern Ireland
Please report directly to NIAIC, further information can be found on the NIAIC website (external link).
Further information about SABS can be found on the SABS website (external link).

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

Health Facilities Scotland - Incident Reporting and Investigation Centre (external link)

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

Email: Haz-Aic@wales.gsi.gov.uk

A manufacturing defect on the posterior chamfer region may result in fracture of the device.

A manufacturing defect on this femoral component has resulted in microscopic cracks, which appear as a linear defect on the posterior chamfer region of the lateral condyle of the implant. This could result in premature fracture of the device. Defective devices could fracture suddenly or, if the cracks propagate over time without fracture, the knee replacements could suffer increased rate of polyethylene wear. Should cracks propagate, they could spread to the bearing surface.

The manufacturer’s investigation by sample testing has determined that approximately 6% of the devices from the affected lots may exhibit microscopic cracks. However, it is not possible to estimate how many of these will fail. In the UK 195 devices from affected lots have been implanted. To date the manufacturer is not aware of any adverse incidents where a fracture has occurred.

Standard view X-rays will not identify failures due to these cracks, but if patients are symptomatic, a tunnel (intracondylar notch) view X-ray of the knee may confirm failure.

The manufacturer has already issued two Field Safety Notices (dated 7 and 28 May 2009) relating to this issue. This Medical Device Alert has been issued to ensure that users are aware of this problem and take appropriate action to monitor affected patients.

• Identify patients implanted with affected devices.
• Consider undertaking clinical assessment of affected patients.
• Consider informing affected patients and their GPs of this problem.

1. Consider the need to:

i) Keep all affected patients under annual review to ensure that those requiring revision are identified in a timely manner.

ii) Advise affected patients of the additional risk of failure and the need for them to contact their GP as soon as possible if they begin to develop any symptoms such as stiffness, pain or swelling.

iii) Inform affected patients’ GPs of this additional risk of failure and advise them to refer symptomatic patients to an orthopaedic consultant.

2. Review symptomatic patients as soon as is practical and consider performing a tunnel (intracondylar notch) view X-ray. 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:

• Care Quality Commission (CQC) (Headquarters)
• 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)
• 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
• fracture clinics
• medical directors
• nursing executive directors
• orthopaedic surgeons
• outpatient clinics
• outpatient theatre managers
• outpatient theatre nurses
• physiotherapists
• radiographers
• radiology departments.

Care Quality Commission (CQC) (England only) to:
The MHRA considers this information to be important to:

• hospitals in the independent sector
• independent treatment centres.

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

• directors of public health
• physiotherapists.

Paul Arnott
DePuy International Ltd
St Anthony’s Road
Leeds
LS11 8DT

Tel: 0113 387 6298
Fax: 0113 387 6087

Email: parnott@its.jnj.com