OPTETRAK
Received Sep 26, 2012 · Event occurred Aug 9, 2012
Report 1038671-2012-00126 · MDR key 2771719
Device
Generic name
Cemented Finned Tibial Tray
Manufacturer
Exactech Inc.Catalog number
200-04-22
Lot number
09071038
Product problems
- Device Operates Differently Than Expected
Patient
58 YR
- No Code Available
Narrative
Description of Event or Problem
RECEIVED A COPY OF MEDWATCH REPORT #0500470000-2012-0071 STATING, "THE PT HAD A RIGHT TOTAL KNEE REVISION DUE TO PROSTHESIS FAILURE. INITIAL KNEE PROCEDURE WAS PERFORMED AT ANOTHER MEDICAL FACILITY. PATHOLOGY REPORT DESCRIBES TWO METALLIC PIECES OF HARDWARE AND ONE PLASTIC PIECE OF HARDWARE."
Additional Manufacturer Narrative
ALTHOUGH THE REPORT STATES TWO METALLIC PIECES OF HARDWARE AND ONE PLASTIC PIECE OF HARDWARE WERE REVISED, ONLY INFORMATION FOR THE TIBIAL TRAY WAS PROVIDED. THE CONTRIBUTION OF THE DEVICE TO THE EXPERIENCE REPORTED COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION.