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MDA/2007/063 - Hip resurfacing implants. Birmingham Hip Resurfacing (BHR) acetabular cups manufactured by Smith & Nephew Orthopaedics Ltd

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/063
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 4
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

Related information:

MHRA pages:

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Page 1

Issued: 15 August 2007 at 14:00
Ref: MDA/2007/063


Tick mark
Immediate action
 
Action
 
Update
Tick mark
Information request


Device:
Hip resurfacing implants.
Birmingham Hip Resurfacing (BHR) acetabular cups manufactured by Smith & Nephew Orthopaedics Ltd (see Appendix for affected lot numbers in pdf only).

 >Page 2

Problem:

  • Inappropriate mixing of head and cup sizes due to incorrect labelling of the cups.
  • The need for early revision due to loose joint fit as a result of mislabelled cups.

 >Page 2

Action by:
Orthopaedic surgeons, Theatre managers		  

Action:

  • Identify and quarantine any unimplanted affected devices (see Appendix in pdf only).
  • DO NOT implant affected devices.
  • Return affected devices to the manufacturer.

 >Page 2

Distributed to:

NHS trusts in England - Chief Executives*
Healthcare Commission (CHAI) - Headquarters
Primary care trusts in England - Chief Executives*

* via CE Bulletin

 >Page 2

Contacts:
Details of manufacturer contacts and MHRA contacts for technical and clinical aspects.
Change of address or removal from address list for Healthcare Commission.		  

 >Pages 2&3

Appendix:
Manufacturer’s list of affected lot numbers in UK (in pdf only).		  

 >Page 4



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 30 August 2007
Deadline (action complete): 15 October 2007


Page last modified: 07 February 2008