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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 083 06 11 000
Date submitted: 6/22/2011
Manufacturer:Zimmer inc
Device Type:NexGen Complete Knee Solution LPS
Description: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.
Remedy Action: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.
Athorized Representative/Importer/Distributor:Ebrahim M. Al-Mana & Bros. Co. Ltd., Riyadh, (01) 4610733
Report Source:NCAR
Source Ref. Number:UK-2011-06-21-085
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments