APEX KNEE SYSTEM
Received Feb 13, 2013 · Event occurred Jan 16, 2013
Report 1226188-2013-00011 · MDR key 2963499
Device
Generic name
Prosthesis, Knee Patello/femorotibial
Manufacturer
Omnlife Science, Inc.Catalog number
KC-2203L
Lot number
8171
Product problems
- Device Slipped
Patient
36 YR
- No Code Available
Narrative
Description of Event or Problem
SALES REPRESENTATIVE REPORTED THAT PATIENT WAS HAVING A REVISION SURGERY AS THE BONE SCAN SHOWED THE TIBIA WAS LOOSENING. INITIAL SURGERY WAS ON (B)(6) 2011 AND REVISION SURGERY WAS ON (B)(6) 2013. THE SALES REPRESENTATIVE REPORTED THAT THERE WAS NOTHING WRONG WITH THE TIBIAL TRAY IMPLANT.
Additional Manufacturer Narrative
THE IMPLANTS WERE NOT RETURNED FOR EXAMINATION; THEREFORE, OMNI COULD NOT CONFIRM THE LOT NUMBERS OF THE PRODUCT REPORTED. BASED ON THE INFORMATION PROVIDED, A REVIEW OF MANUFACTURING LOT RECORDS WAS PERFORMED. ALL IMPLANT LOT RECORDS WERE REVIEWED AND THERE WERE NO DEVIATIONS REPORTED.