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MDA/2007/092 - Total knee replacement implants. VKS, RT-Plus and TC-Plus femoral and tibial knee components manufactured by Plus Orthopaedics/Smith & Nephew Orthopaedics Ltd (specific lot numbers)

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/092
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 5
Price: Free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 04 December 2007 at 15:30
Ref: MDA/2007/092

 

 Tick mark
Immediate action
 
Action
 
Update
 Tick mark
Information request


Device:
Total knee replacement implants.
VKS, RT-Plus and TC-Plus femoral and tibial knee components manufactured by Plus Orthopaedics/Smith & Nephew Orthopaedics Ltd (specific lot numbers).

 

Problem:
Implants may have incorrect alloy composition.

>Page 2

Action by:

  • Orthopaedic surgeons
  • Theatre managers
  • Theatre nurses
  

Action:

  • Do not implant affected products (lot numbers listed in appendix)
  • Quarantine all affected products and return them to the manufacturer
  • Report revisions or adverse incidents related to affected products to the MHRA.
 

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 products distributed to UK hospitals (in pdf only).		  

>Pages 4-5



 

Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 14 December 2007
Deadline (action complete): 04 March 2008

Page last modified: 04 December 2007