IBALANCE PATELLA IMPLANT DOME, 34 X 9 MM
Received Oct 18, 2019 · Event occurred Sep 19, 2019
Report 1220246-2019-01365 · MDR key 9207325
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
- Appropriate Device Problem Term/Code Not Available
Patient
64 YR
- Pain
- Pain
Narrative
Additional Manufacturer Narrative
THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS REQUESTED/IS EXPECTED BUT HAS NOT BEEN 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 THE PATIENT HAD UNDERGONE A RIGHT TKA PROCEDURE ON (B)(6) 2015. DURING THE ORIGINAL PROCEDURE THE PATELLA WAS RESURFACED. THE PATIENT WAS EXPERIENCING PAIN AND UNDERWENT A REVISION RIGHT TKA PROCEDURE ON (B)(6) 2019. THE REVISION PROCEDURE WAS COMPLETED BY IMPLANTING ANOTHER MANUFACTURER'S PRODUCT. DURING THE REVISION THE FOLLOWING ARTHREX PRODUCTS WERE EXPLANTED: TIBIAL TRAY IMPLANT, AR-503-TTTH, LOT 1337240, FEMORAL IMPLANT, AR-516-7R, LOT 108761331, BEARING IMPLANT, AR-513-BH12, LOT 113601409, PATELLA IMPLANT, AR-504-PSC9, LOT 113601430.
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.