CARTIVA IMPLANTS

Description of Event or Problem

ON (B)(6) 2017, I HAD BILATERAL TOE SURGERY TO PLACE CARTIVA IMPLANTS IN MY GREAT TOES DUE TO SEVERE HALLUX RIGIDUS. THE SURGERY WAS PERFORMED BY DR (B)(6) IN (B)(6). I DILIGENTLY WENT THROUGH PHYSICAL THERAPY. I FOLLOWED-UP WITH DR (B)(6) ON TWO SEPARATE OCCASIONS IN 2018 DUE TO PAIN IN MY TOES, LACK OF BALANCE AND RIGIDITY IN MY TOES. EACH TIME, I HAD X-RAYS AND WAS TOLD THAT I WAS STILL SWOLLEN AND HEALING." ON (B)(6) 2019 I RETURNED TO DR (B)(6) FOR MY ONE YEAR F/U. I HAD REPEAT X-RAYS AND WAS TOLD THAT BOTH CARTIVA IMPLANTS HAD FAILED. THEY HAD RECEDED AND BOTH TOE JOINTS ARE "BONE-ON-BONE." DR (B)(6) INFORMED ME AT THIS APPT THAT HE NO LONGER PERFORMS THE CARTIVA IMPLANT SURGERY DUE TO ITS HIGH FAILURE RATE, WHICH HE CLAIMED IS AROUND 50% AND NOT THE 90% SUCCESS RATE CLAIMED BY THE CARTIVA COMPANY. BOTH X-RAYS REVEALED THE CARTIVA IMPLANTS HAD RECESSED. FDA SAFETY REPORT ID# (B)(4).