Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.
Page 1
| Issued: 18 September 2008 at 14:00 |
Ref: MDA/2008/066
|
|
|
Immediate action |
|
Action |
|
|
Update |
|
|
Information request |
| Device: Total knee replacement implants: Stryker Orthopaedics Kinemax Plus Revision TS Tibial Inserts (specific product and lot codes – see Appendix in pdf only). |
|||||||||
| Problem: Risk of loosening, excessive wear and fracture of knee replacement components, due to a manufacturing defect. |
>Page 2 |
||||||||
|
Action by:
|
|
||||||||
|
Action:
|
>Page 2 |
||||||||
|
Distributed to:
* via CE Bulletin |
>Page 2 |
||||||||
| Contacts: Details of manufacturer contacts and contacts for technical and clinical aspects. Change of address or removal from address list for Healthcare Commission. |
>Page 2 |
||||||||
| Appendix: Manufacturer’s Field Safety Notice (in pdf only) |
>Pages 4-7 |
|
Action deadlines for the Central Alerting System (CAS)
|
|
|
Deadline (action underway): 03 October 2008
|
Deadline (action complete): 31 October 2008
|
MDA/2008/066 - Total knee replacement implants: Stryker Orthopaedics Kinemax Plus Revision TS Tibial Inserts 
