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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 083 06 11 000
NexGen Complete Knee Solution LPS
Prostheses, Joint, Knee, Femoral Component
Medical Device Identifier:
00599601502, 00599601601, 00599601602, 00599601701, 00599601702
Reason of Field Safety Corrective Action:
Zimmer has determined that the femoral component of a knee implant has an undersized CAM radius due to a manufacturing error. This may cause polyethylene delamination and fatigue fracture due to higher contact stresses. Zimmer is not recommending any enhanced patient follow-up.
Return affected product. Zimmer has increased the awareness of this CAM radius feature and increased the training for the use of the gauge to measure this feature. They are also evaluating the CAM radius measurement method to determine if operator variability can be minimised.
Ebrahim M. Al-Mana & Bros. Co. Ltd., Riyadh, (01) 4610733
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.