Description of Event or Problem · 1
KNEE IMMOBILIZATION [JOINT RANGE OF MOTION DECREASED]; DIFFICULTY MOVING [MOBILITY DECREASED]; KNEE WARMTH [JOINT WARMTH]; KNEE SWELLING [JOINT SWELLING]; THERMAL PAIN [ARTHRALGIA]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2009 FROM A PHYSICIAN REGARDING A (B)(6) FEMALE PATIENT, INITIALS (B)(6). THE PATIENT RECEIVED HER THIRD SERIES OF SYNVISC INJECTIONS INTO THE KNEE(S) WITH TWO INJECTIONS BEING ADMINISTERED ON (B)(6) 2009 AT A DOSE OF 2 ML ADMINISTERED VIA INTRA-ARTICULAR ROUTE (FREQUENCY UNKNOWN). THE PATIENT'S MEDICAL HISTORY INCLUDES OSTEOARTHRITIS. ON (B)(6) 2009, AFTER THE FIRST SYNVISC INJECTION, THE PATIENT EXPERIENCED KNEE PAIN AND KNEE SWELLING THAT RESULTED IN THE USE OF ICE PACKS. ON (B)(6) 2009, ONE TO TWO DAYS AFTER THE SECOND SYNVISC INJECTION, THE PATIENT EXPERIENCED SIGNIFICANT KNEE SWELLING AND KNEE PAIN ASSOCIATED WITH SENSATION OF WARMTH (THERMAL PAIN). THE KNEE WAS SO SWOLLEN THAT THE PATIENT COULDN'T BEND HER KNEE AND BECAUSE IT WAS AN ELDERLY PATIENT IT WAS DIFFICULT FOR HER TO MOVE. SYNVISC THERAPY WAS PERMANENTLY DISCONTINUED. THE PATIENT RECEIVED TREATMENT WITH A COMBINATION OF STEROID AND NSAID THAT WAS ONGOING AT THE TIME OF THIS REPORT. THE PHYSICIAN REPORTED THAT HE HAD NEVER OBSERVED SO SEVERE SYMPTOMS. AS OF THE DATE OF RECEIPT OF THIS REPORT THE PATIENT WAS NOT YET RECOVERED. THE PHYSICIAN ASSESSED THE RELATIONSHIP BETWEEN THE REPORTED ADVERSE EVENTS AND SYNVISC THERAPY AS DEFINITELY RELATED.