Description of Event or Problem · 1
THIS SOLICITED DEVICE CASE WAS RECEIVED FROM (B)(6) ON (B)(6)-2014 FROM A CONSUMER VIA PATIENT SUPPORT PROGRAM. THE CASE CONCERNS A (B)(6) FEMALE PATIENT WHO DEVELOPED RIGHT KNEE SWOLLEN/HUGE, RIGHT KNEE PAIN/VERY BAD JABBING PAIN, ALLERGY TO SYNVISC INJECTIONS, A PIN ALL ALONG LEG (THIGH AND ANKLE) / SHOOTING PAIN, DRAINED THE RIGHT KNEE AFTER TREATMENT WITH SYNVISC USED FOR OSTEOPOROSIS (OFF LABEL USE). THE PATIENT'S MEDICAL HISTORY INCLUDED THYROID ISSUES (THYROID WAS OUT OF WACK) WHICH CAUSED ATRIAL FIBRILLATION (THREE MONTHS AGO). FAMILY HISTORY INCLUDED RHEUMATOID ARTHRITIS. PAST DRUG INCLUDES USE OF SYNVISC (TWO LOTS: ONE IN NOV IN LEFT KNEE). NO CONCURRENT CONDITIONS WERE REPORTED. CONCOMITANT MEDICATIONS INCLUDED ACETYLSALICYLIC ACID (ASPIRING; RECENTLY STARTED), PANCREATIN (CREON), PLATELET RICH PLASMA (PRP) AND LEVOTHYROXINE SODIUM (THYROXINE). ON AN UNSPECIFIED DATE IN 2014, THE PATIENT RECEIVED TREATMENT WITH SYNVISC INJECTION (ROUTE, BATCH/LOT NUMBER AND EXPIRATION DATE UNK) AT A DOSE OF 2 ML FOR OSTEOPOROSIS (OFF LABEL USE). THE PATIENT RECEIVED A TOTAL OF 3 DOSE OF SYNVISC IN 6 WEEKS. AFTER THE FIRST INJECTION IN FIRST WEEK, THE PATIENT'S KNEE STARTED TO SWELL. IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS BONE ON BONE. ON AN UNSPECIFIED DATE, THE PATIENT'S KNEE WAS DRAINED AND CORTISONE WAS ADMINISTERED. THE SECOND INJECTION WAS ADMINISTERED IN THE SECOND WEEK. THE PATIENT HAD SAME EFFECT (SWOLLEN KNEE) AND WAS ADMINISTERED CORTISONE. AFTER THE 2ND INJECTION IN HER RIGHT KNEE, THE PATIENT EXPERIENCED PAIN FOR ONE AND A HALF WEEKS. IT WAS REPORTED THAT THE PATIENT USUALLY TAKES 2-3 DAYS BEFORE GOING BACK ON HER FEET BUT THIS TIME ROUND SHE GAVE IT 1.5 DAYS. THE PATIENT STILL HAD SWOLLEN KNEE (SLIGHTLY SWOLLEN HUGE KNEE). ALSO, THE PATIENT EXPERIENCED SHOOTING PAIN ALL ALONG LEG (THIGH AND ANKLE). THE NEXT DAY, THE PATIENT'S KNEE WAS DRAINED AGAIN. THE PATIENT WAS ADVISED TO LET HER KNEE SETTLE DOWN FOR 2 WEEKS. THE PATIENT WAS SCHEDULED FOR A VISIT ON (B)(6)-2014. ON AN UNSPECIFIED DATE, THE PATIENT'S SWELLING WAS DOWN (A BIT SWOLLEN) BUT PAIN WAS STILL PRESENT. THE PATIENT WAS THEN ADMINISTERED 3RD INJECTION AND THE PATIENT EXPERIENCED VERY BAD JABBING PAIN ALL NIGHT. THE NEXT DAY, A LOT OF FLUID WAS DRAINED FROM PATIENT'S KNEE AND WAS ADVISED TO LEAVE IT FOR 2 WEEKS. AT THE TIME OF THE REPORT, THE PATIENT'S KNEE WAS PAINFUL. THE DOCTORS ADVISED THE PATIENT TO KEEP HER LEG UP AS MUCH AS POSSIBLE AND TO REFER TO A PHYSIOTHERAPIST WHO GOT HER TO DO POOL EXERCISES WHICH WAS STILL ONGOING. IT WAS REPORTED THAT THE PATIENT MAY BE ALLERGIC TO SYNVISC. ACTION TAKEN: NO ACTION TAKEN. OUTCOME: RIGHT KNEE PAIN / VERY BAD JABBING PAIN: NOT RECOVERED / NOT RESOLVED. RIGHT KNEE SWOLLEN / HUGE, ALLERGY TO SYNVISC INJECTIONS, PAIN ALL ALONG LEG (THIGH AND ANKLE) / SHOOTING PAIN, PAIN ALL ALONG LEG (THIGH AND ANKLE) / SHOOTING PAIN AND DRAINED THE RIGHT KNEE: UNK. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER: (B)(4). THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH RECORD REVIEW WAS NOT POSSIBLE. BASE DON THE LACK OF INFORMATION PROVIDED, NO CAPA WAS REQUIRED. IT WAS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR SPECIFICATION CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT WAS IDENTIFIED AND MITIGATED THROUGH THE NCR PROCESS. DATA WAS PERIODICALLY PRESENTED AND REVIEWED BY INDIVIDUALS RESPONSIBLE FOR ASSURING PRODUCT SAFETY. THIS REVIEW HAS NOT INDICATED ANY SAFETY ISSUE. GENZYME BIOSURGERY WILL CONTINUE TO MONITOR ADVERSE EVENTS TO DETERMINE IF A CAPA WAS REQUIRED. REPORTER'S CAUSALITY: NOT REPORTED. COMPANY CAUSALITY: ASSOCIATED. NO FURTHER INFORMATION WAS AVAILABLE. 1CONSENT FOR FOLLOW UP WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6)-2014. PTC RESULTS WERE ADDED. PHARMACOVIGILANCE COMMENT: SANOFI COMPANY FOLLOW UP COMMENT DATE (B)(6)-2014: THE FOLLOW UP INFORMATION RECEIVED DOES NOT CHANGE THE OVERALL ASSESSMENT OF THE CASE. SANOFI COMPANY COMMENT DATE (B)(6)-2014: THIS CASE CONCERNS A PATIENT WHO WAS DEVELOPED "RIGHT KNEE SWOLLEN / HUGE" AND "RIGHT KNEE PAIN / VERY BAD JABBING PAIN" AFTER RECEIVING SYNVISC FOR OSTEOPOROSIS. ALTHOUGH THE ROLE OF DEVICE CANNOT BE RULED OUT BASED ON THE DEVICE EVENT TEMPORAL RELATIONSHIP; HOWEVER, LACK OF DETAILED INFORMATION ABOUT MEDICAL HISTORY, LAB DATA, ANY CONCURRENT MEDICAL ILLNESSES, CLINICAL COURSE ETC. OF THE PATIENT PRECLUDES A COMPREHENSIVE ASSESSMENT IN THIS CASE.