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MDA/2007/067 - Hip resurfacing implants. Adept acetabular cups manufactured by Finsbury Orthopaedics

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/067
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 4
Price:
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 29 August 2007 at 14:00
Ref: MDA/2007/067


Tick mark
Immediate action
 
Action
 
Update
Tick mark
Information request


Device:
Hip resurfacing implants.
Adept acetabular cups manufactured by Finsbury Orthopaedics (see appendix for affected lot codes).

 >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).
  • 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 contact 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 codes in the UK (in pdf document only).		  

 >Page 4


Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 10 September 2007
Deadline (action complete): 24 October 2007


Page last modified: 29 August 2007