IBALANCE PATELLA IMPLANT DOME, 34 X 9 MM
Received Nov 4, 2019 · Event occurred Oct 7, 2019
Report 1220246-2019-01391 · MDR key 9272306
Device
Generic name
- Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer
Manufacturer
Arthrex, Inc.Model number
IBALANCE PATELLA IMPLANT DOME, 34 X 9 MMCatalog number
AR-504-PSC9
Lot number
113601430
Product problems
- Loose or Intermittent Connection
Patient
60 YR
- Pain
- Pain
Narrative
Additional Manufacturer Narrative
COMPLAINT NOT CONFIRMED, NO EVIDENCE WAS FOUND THAT MAY HAVE CONTRIBUTED TO THE EVENT. DURING THE REVISION SURGERY THE SURGEON CHOSE TO ALSO REMOVE THIS DEVICE. THE DAMAGE OBSERVED WAS MOST LIKELY CAUSED BY THE DEVICE EXTRACTION.
Additional Manufacturer Narrative
THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.
Description of Event or Problem
IT WAS REPORTED THAT ON (B)(6) 2015 THE PATIENT HAD UNDERGONE A BI-LATERAL TKA PROCEDURE. ON (B)(6) 2019 THE PATIENT UNDERWENT A REVISION RIGHT TKA PROCEDURE DUE TO PAIN AND TIBIAL LOOSENING. DURING THE REVISION PROCEDURE THE FOLLOWING ORIGINAL ARTHREX IMPLANT DEVICES WERE EXPLANTED: AR-503-TTTG, TIBIAL TRAY IMPLANT (LOT 108761215), AR-516-7R, FEMORAL IMPLANT (LOT 108761338), AR-513-BG11, TIBIAL BEARING IMPLANT (LOT 113601405), AR-504-PSC9, PATELLA IMPLANT (LOT 113601430). THE REVISION PROCEDURE WAS COMPLETED BY IMPLANTING ANOTHER MANUFACTURER'S DEVICES.