Description of Event or Problem · 1
THIS UNSOLICITED DEVICE CASE WAS RECEIVED FROM (B)(6) ON (B)(6) 2014 FROM A PHYSICIAN. THIS CASE IS CROSS REFERRED TO (B)(4) (CLUSTER, SAME REPORTER). THIS CASE INVOLVES (B)(6) MALE PATIENT WHO EXPERIENCED INJECTION SITE JOINT INFECTION THAT EXTENDED TO THE CALF AFTER RECEIVING TREATMENT WITH SYNVISC ONE. NO MEDICAL HISTORY, PAST DRUGS, CONCURRENT CONDITION OR CONCOMITANT MEDICATION WAS REPORTED. ON AN UNKNOWN DATE IN 2014 (IN THE BEGINNING), THE PATIENT RECEIVED TREATMENT WITH INTRAARTICULAR SYNVISC ONE INJECTION ONCE (DOSE, BATCH/LOT NUMBER AND EXPIRY DATE: UNKNOWN) INTO UNSPECIFIED KNEE FOR GONARTHROSIS. ON AN UNKNOWN DATE IN 2014, ONE WEEK LATER, THE PATIENT DEVELOPED INFECTION ON THE INJECTION SITE. ON AN UNKNOWN DATE IN 2014, THE PATIENT WAS HOSPITALIZED, THE PATIENT RECEIVED TREATMENT WITH ANTIBIOTHERAPY. THE INFECTION LATER EXTENDED TO THE CALF. ARTHROTOMY WAS PERFORMED AND INFECTED TISSUES WERE DISSECTED. NO GERMS WERE FOUND. ACTION TAKEN: PERMANENTLY DISCONTINUED. OUTCOME: RECOVERED/RESOLVED. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED AND CONCLUSION WAS PENDING FOR THE SAME. SERIOUSNESS CRITERIA: HOSPITALIZATION. REPORTER'S CAUSALITY: NOT REPORTED. (B)(4). PHARMACOVIGILANCE COMMENT: SANOFI COMPANY COMMENT DATE (B)(4) 2014: THIS CASE CONCERNS A PATIENT WHO WAS HOSPITALIZED DUE TO INJECTION SITE JOINT INFECTION THAT EXTENDED TO CALF AFTER RECEIVING SYNVISC ONE INJECTION FOR GONARTHROSIS. ALTHOUGH THE ROLE OF DEVICE CANNOT BE RULED OUT BASED ON THE DRUG 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.