Description of Event or Problem · 1
(B)(6) 2014, DR (B)(6) OF (B)(6) ORTHOPAEDIC CLINIC IN (B)(6) PERFORMED A TOTAL LEFT KNEE ARTHROPLASTY. (B)(6) 2015 DURING THERAPY, I FELT A VERY SHARP PAIN AS MY THERAPIST MOBILIZED MY KNEE. HE ATTRIBUTED THE PAIN TO SCAR TISSUE. SOON AFTER THAT MOBILIZATION, I BEGAN FEELING AN ODD SENSATION WHEN DOING STRENGTH EXERCISES. I STARTED COMPLAINING ABOUT THE SENSATION IN (B)(6) AND EVEN VISITED DR (B)(6). HE ATTRIBUTED THE SENSATION TO "STARTING" PAIN, AND THAT IT WOULD GO AWAY. THE PAIN DID NOT AND THE SENSATION GOT MORE AND MORE PRONOUNCED. IN (B)(6), I INSISTED DR (B)(6) SEE ME AND AT THIS POINT HE PERFORMED AN X-RAY WHICH CONFIRMED THAT MY TIBIAL IMPLANT HAD BROKEN FREE OF ITS CEMENT BOND. (B)(6) 2015 I HAD REVISION SURGERY (1ST REVISION SECOND TKA). (B)(6) 2016, MY RANGE OF MOTION IMPROVEMENT HIT A WALL AND I STARTED TO LOSE FLEXIBILITY. DR (B)(6) AND MY THERAPIST SAID THAT THIS WAS NOT ABNORMAL AND THAT I SHOULD PRESS FORWARD. OVER THE SUBSEQUENT MONTHS, I KEPT TRYING HARDER WITH LITTLE TO NO RESULTS. I KEPT INSISTING THAT THERE WAS SOMETHING 'WRONG' WITH KNEE AND WOULD SEE DR (B)(6). X-RAYS WERE TAKEN AND DR (B)(6) SAID THAT THE IMPLANTS LOOKED SECURE. I KEPT AT THERAPY 3X A WEEK RELIGIOUSLY UNTIL (B)(6), WHEN I BEGAN TO EXPERIENCE SHARP PAIN IN MY KNEE WHEN WALKING. I VISITED DR (B)(6) YET AGAIN AND HE SAID THAT THE ONLY EXPLANATION WAS THAT SCAR TISSUE WAS GROWING INTO THE JOINT AREA AND MY WALKING / EXERCISING WAS IRRITATING IT, CAUSING PAIN AND SWELLING. DR (B)(6) SCHEDULED AN ADD'L ARTHROSCOPY FOR (B)(6) 2016 AND REMOVED SCAR TISSUE. (B)(6) 2017 , MY KNEE STARTED TO FEEL TIGHT. I SCHEDULED A VISIT WITH DR (B)(6) ASAP. (B)(6) 2017, DR(B)(6) IDENTIFIED FLUID BUILDUP ON MY KNEE AS THE CAUSE OF MY DISCOMFORT AND PAIN. HE PERFORMED ARTHROCENTESIS (OVER 30ML) AND TOLD ME THAT I COULD EXPECT TO SEE HIM EVERY THREE OR FOUR MONTHS TO REPEAT THE PROCEDURE GOING FORWARD. (B)(6) 2017, MY KNEE STARTED FEELING TIGHT AGAIN. TOC REMOVED FLUID BUILDUP AGAIN BUT SAID NO OTHER ISSUE. MY FAITH WITH TOC WAS NOW AT AN END AND I REACHED OUT TO THE (B)(6) CLINIC IN (B)(6). (B)(6) 2017, CONSULTATION WITH (B)(6) CLINIC REVEALS THAT BOTH UPPER AND LOWER IMPLANTS ARE LOOSE AND NEED TO BE REPLACED. DR (B)(6), MY ORTHO SURGEON SAID THAT MY REVISION TKA WAS DOOMED TO FAIL IN A PT OF MY AGE AND ACTIVITY LEVEL - A QUESTION OF IT, NOT WHEN. SECOND REVISION (THIRD TKA WITHIN 3 YEARS) IMPLANTED BY (B)(6) (B)(6) 2017. FDA SAFETY REPORT ID# (B)(4).