Description of Event or Problem · 1
THIS UNSOLICITED DEVICE CASE FROM (B)(6) WAS RECEIVED ON (B)(6) 2014 FROM AN ORTHOPEDIST VIA MARKETING PARTNER ((B)(4)). THIS CASE IS CROSS REFERENCED WITH CASE (B)(4) (SAME PT). THIS CASE CONCERNS A (B)(6) MALE PT WHO DEVELOPED "BLOODY EFFUSION", JOINT EFFUSION AND JOINT SWELLING (LEFT KNEE) AFTER RECEIVING TREATMENT WITH SYNVISC. RELEVANT MEDICAL HISTORY INCLUDED PREVIOUS USE OF SYNVISC (ADMINISTRATION DATES; (B)(6) 2013 (2ML INTO THE LEFT KNEE FOR GONARTHROSIS), (B)(6) 2014 ALL INTO LEFT KNEE). NO OTHER PAST DRUGS, CONCURRENT CONDITION OR CONCOMITANT MEDICATION WAS REPORTED. AT A HOSPITAL VISIT ON (B)(6) 2014, THE PT REPORTED THAT THE PAIN HAD BEEN DECREASED AND HE BECAME ABLE TO WALK FAST. ON (B)(6) 2014, THE PT HAD ARTHROCENTESIS (VOLUME: 50 ML) AND THEN RECEIVED TREATMENT WITH INTRA-ARTICULAR SYNVISC INJECTION (LOT/ BATCH NUMBER AND EXPIRATION DATE UNK) AT A DOSE OF 2ML ONCE INTO THE LEFT KNEE FOR GONARTHROSIS (SEVERITY OF HIS GONARTHROSIS WAS PROBABLY MILD, BUT KELLGREN-LAWRENCE GRADE HAD NOT BEEN DETERMINED YET). THE SAME DAY, IN THE EVENING, THE PT EXPERIENCED JOINT SWELLING (LEFT KNEE) WHICH ENLARGED DURING THE NIGHT. ON (B)(6) 2014, THE PT VISITED THE HOSPITAL AND HAD ARTHROCENTESIS AT 145 ML (JOINT EFFUSION). LABORATORY RESULTS SHOWED C-REACTIVE PROTEIN (CRP) AT 0.45 MD/DL AND WHITE BLOOD CELL COUNT AT 7200/MM3 (REF. RANGE NOT REPORTED). HE UNDERWENT ARTHROCENTESIS AGAIN ON (B)(6) 2014 (95 ML, MILDLY BLOODY) AND ON (B)(6) 2014 (65 ML); HOWEVER, THE EVENT HAD NOT RESOLVED YET. IT WAS ALSO REPORTED THAT THE PT SOMETIMES WENT PLAYING GOLF EVEN WHEN HE HAD A PAIN. ACTION TAKEN: STOPPED TEMPORARILY. CORRECTIVE TREATMENT: ARTHROCENTESIS FOR JOINT EFFUSION, JOINT SWELLING (LEFT KNEE) AND BLOODY EFFUSION. OUTCOME: JOINT EFFUSION AND BLOODY EFFUSION: UNK. JOINT SWELLING (LEFT KNEE): NOT RECOVERED/ NOT RESOLVED. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER # (B)(4) AND RESULTS WERE PENDING FOR THE SAME. JOINT SWELLING (JOINT SWELLING). REPORTING PHYSICIAN'S CAUSALITY ASSESSMENT: PROBABLE. JOINT EFFUSION. REPORTING PHYSICIAN'S CAUSALITY ASSESSMENT: NOT REPORTED. BLOODY EFFUSION (HEMARTHROSIS). REPORTING PHYSICIAN'S CAUSALITY ASSESSMENT: NOT REPORTED. SERIOUSNESS ASSESSMENT: IMPORTANT MEDICAL EVENT. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATED ON (B)(6) 2014: THIS CASE CONCERNS A PT WHO DEVELOPED BLOODY EFFUSION, JOINT EFFUSION AND JOINT SWELLING (LEFT KNEE) WHILE RECEIVING SYNVISC FOR GONARTHROSIS. ALTHOUGH THE ROLE OF DEVICE CANNOT BE RULED OUT; HOWEVER, LACK OF DETAILED INFO ABOUT MEDICAL HISTORY, LAB DATA, ANY CONCURRENT MEDICAL ILLNESSES, CLINICAL COURSE ETC. OF THE PT PRECLUDES A COMPREHENSIVE ASSESSMENT IN THIS CASE.