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MDA/2007/054 - Total hip replacement: DePuy Ultima TPS femoral stem used in combination with Ultima metal-on-metal articulation

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/054
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 6
Price: Free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 14 June 2007 at 12:00
Ref: MDA/2007/054

 

 
Immediate action
 Tick mark
Action
 
Update
 Tick mark
Information request


Device:
Total hip replacement: DePuy Ultima TPS femoral stem used in combination with Ultima metal-on-metal articulation.

 >Page 2

Problem:

  • Unexplained groin pain.
  • The need for early revision due to periprosthetic soft tissue necrosis.

 >Page 2

Action by:
Orthopaedic surgeons.		  

Action:
Refer patients with this implant combination who present with unexplained groin pain for MRI scan. This is in line with the parameters recommended by DePuy (see recommendations for patient management under ‘Action’ in the appendix). Patients with abnormal signs should be considered for an early revision.

Report all revisions of metal-on-metal articulations where corrosion and/or periprosthetic soft tissue reaction are observed to the implant manufacturer and 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:
Letter from DePuy (in pdf only).		  

 >Pages 4-6



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 17 July 2007
Deadline (action complete): 17 August 2007


Page last modified: 14 June 2007