CARTIVA IMPLANT

Description of Event or Problem

RECEIVED A CARTIVA JOINT REPLACEMENT IMPLANT IN MY LEFT BIG TOE TO HELP RESOLVE HALLUX RIGIDUS. IN MORE THAN A YEAR POST-SURGERY, MY PAIN HAS INCREASED TO LEVELS WORSE THAN IT WAS BEFORE SURGERY. RECEIVED A SECOND OPINION FROM ANOTHER SURGEON WHO STATED THAT THE JOINT SPACE HAS DECREASED SIGNIFICANTLY AND SHE RECOMMENDS REMOVING THE CARTIVA IMPLANT AND REPLACING IT WITH A HEMICAP IMPLANT. SHE MENTIONED SHE SEES A LOT OF FAILED CARTIVA IMPLANTS. SURGERY TO REMOVE CARTIVA AND REPLACE IT WITH HEMICAP SCHEDULED FOR (B)(6) 2019. FDA SAFETY REPORT ID # (B)(4).