OtherHSH
OPTETRAK
Received Nov 21, 2012 · Event occurred Oct 24, 2012
Report 1038671-2012-00138 · MDR key 2849260
Device
Generic name
Tibial Insert
Manufacturer
Exactech, Inc.Product problems
- Insufficient Device Problem Information
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
REVISION OF TIBIAL INSERT. SURGEON NOTED WEAR ON THE INSERT AND REPORTED BONE GROWTH ON THE FEMUR. PRIMARY SURGERY OCCURRED IN (B)(6) OF 2012.
Additional Manufacturer Narrative
RETURNED DEVICES ARE CURRENTLY UNDERGOING ENGINEERING EVALUATION.