Description of Event or Problem · 0
THIS SPONTANEOUS CONSUMER MEDICALLY CONFIRMED REPORT RECEIVED FROM BIOVENTUS (REF. NR. (B)(4) ON (B)(6) 2022 AS INITIAL REPORT (MERGED WITH FU1 RECEIVED ON (B)(6) 2022, FU2 RECEIVED ON (B)(6) 2022 AND FU3 RECEIVED ON (B)(6) 2022) DESCRIBES THE OCCURRENCE OF SWELLING, PAIN EXACERBATION WITH FUNCTIONAL LIMITATION AND INFECTION, IN A FEMALE PATIENT (AND AGE) WHO RECEIVED GELSYN-3 (HYALURONATE SODIUM 0.84 %), INJECTION, FOR OSTEOARTHRITIS DEGENERATIVE JOINT IN THE LEFT KNEE. THE CASE, INITIALLY REPORTED AS NON-SERIOUS, WAS UPGRADED TO SERIOUS (FOR HOSPITALIZATION) WITH THE FU1 INFORMATION (RECEIVED ON (B)(6) 2022). PATIENT REPORTED TO HAVE RECEIVED 3 SHOTS OF GELSYN 3. THE FIRST SHOT AND THE SECOND SHOT DID NOT GIVE PROBLEM AND SEEMED TO BE NO CHANGES. ONLY 20% SIGHT IMPROVEMENT WITH OSTEOARTHRITIS DEGENERATIVE JOINT IN THE LEFT KNEE. THE 3RD SHOT LEFT THE PATIENT TOTALLY DEBILITATED IN THE LEFT KNEE; THE KNEE BEGAN TO SWELL TREMENDOUSLY. PATIENT COULD NOT WALK OR RAISE BY LEG, GET IN A CAR OR CONTINUE WITH THE ACTIVITIES OF DAILY LIVING. PATIENT CANNOT CARE FOR HERSELF. THE ORTHOPEDIC DREW FLUID TO TEST FOR INFECTION. PATIENT DID NOT HAVE RESULTS AT THE TIME OF REPORTING. PATIENT REPORTED TO HAVE SEVERE OSTEOARTHRITIS AND DID NOT UNDERSTAND A SHOT CAUSING THIS MUCH HURT AND HARM. PATIENT WAS ON CRUTCHES AND ALL ACTIVITIES WERE HARD AND WAS NOT THIS WAY BEFORE THE SHOTS AND NEEDED HELP FOR THE ACTIVITIES. THE ORTHOPEDIC SURGEON WAS REVIEWING TIMING FOR KNEE REPLACEMENT. NO FURTHER INFORMATION WAS AVAILABLE. FU1 (B)(6) 2022): THE PHYSICIAN REPORTED THAT THE TEST RESULTS SHOWED AN INFECTION; THE PATIENT ADDED THAT WAS HOSPITALIZED AND WAS ON IV ANTIBIOTICS FOR 6 WEEKS. NO FURTHER INFORMATION WAS AVAILABLE. FU2 (B)(6) 2022): THE FOLLOWING ADDITIONAL INFORMATION WERE RECEIVED FROM THE PHYSICIAN: THE MEDICAL PROFESSIONAL'S ASSESSMENT ON THE RELATIONSHIP BETWEEN THE REPORTED EVENT AND GELSYN-3 WAS UNKNOWN (TEST RESULTS PENDING); THERE WERE NO CONTRIBUTORY MEDICATION CHANGES OR OTHER EXTERNAL FACTORS PRECEDING THE ONSET OF THE EVENT; THE GELSYN-3 LOT NUMBER WAS 2109061 (FIRST INJECTION), 2109079 (SECOND AND THIRD INJECTIONS); THE SYMPTOMS STARTED APPROXIMATELY 10 HOURS AFTER THE THIRD INJECTION OF GELSYN-3; THE JOINT INJECTED WAS LEFT KNEE; THE APPROACH USED WAS: GELSYN-3 INJECTED INTO JOINT SPACE (PREFILLED SYRINGE AND NEEDLE PROVIDED), CLEANSED WITH IODINE X 3 ALCOHOL; THE PATIENT'S CURRENT STATUS WAS: PATIENT STAID IN HOME HEALTH ON IV ANTIBIOTICS, PAIN AND SWELLING CONTINUED; MEDICAL INTERVENTION WAS REQUIRED TO TREAT THE EVENT; PATIENT HAD NOT OTHER RELEVANT MEDICAL CONDITIONS OR PRIOR REACTIONS TO MEDICATIONS; THE PATIENT'S DIAGNOSIS WAS OF EFFUSION OF THE LEFT KNEE AND SEVERE, OTHERWISE UNSPECIFIED OSTEOARTHRITIS. NO FURTHER INFORMATION WAS AVAILABLE. FU3 (B)(6) 2022): QUALITY INVESTIGATION RESULTS ON BOTH BATCHES WERE RECEIVED. IN PARTICULAR. QA INV. RESULTS (BATCH 2109061): THE REVIEW OF THE MANUFACTURING AND PACKAGING RECORDS OF BATCH 2109061 SHOWED NO ANOMALIES. THE REVIEW OF THE ANALYSIS OF THE RAW MATERIALS AND THE PRIMARY AND SECONDARY PACKAGING COMPONENTS THAT COME IN CONTACT WITH THE PRODUCT (SYRINGES, PLUNGER STOPPERS AND NEEDLE) USED FOR THE PRODUCTION OF BATCH 2109061 SHOWED NO ANOMALIES: ALL OF THEM WERE CONFORMANT, IN COMPLIANCE WITH THE SPECIFICATIONS. ALL THE IN PROCESS CONTROLS AND RELEASE CONTROLS, BOTH MICROBIOLOGICAL (BIOBURDEN, STERILITY TEST, BACTERIAL ENDOTOXINS) AND CHEMICAL (DYNAMIC AND INTRINSIC VISCOSITY, PH, OSMOLALITY, SODIUM HYALURONATE ASSAY) ONES WERE IN COMPLIANCE WITH THE SPECIFICATION. THEREFORE, THE INVESTIGATION PERFORMED DOESN'T SHOW ANY PROBLEM RELATED TO THE QUALITY OF THE PRODUCT AND IBSA EXCLUDES THAT THE ADVERSE EVENT IS RELATED TO AN ANOMALY OR DEFECT IN THE MANUFACTURING PROCESS OF BATCH 2109061. QA INV. RESULTS (BATCH 2109079): THE REVIEW OF THE MANUFACTURING AND PACKAGING RECORDS OF BATCH 2109079 SHOWED NO ANOMALIES. THE REVIEW OF THE ANALYSIS OF THE RAW MATERIALS AND THE PRIMARY AND SECONDARY PACKAGING COMPONENTS THAT COME IN CONTACT WITH THE PRODUCT (SYRINGES, PLUNGER STOPPERS AND NEEDLE) USED FOR THE PRODUCTION OF BATCH 2109079 SHOWED NO ANOMALIES: ALL OF THEM WERE CONFORMANT, IN COMPLIANCE WITH THE SPECIFICATIONS. ALL THE IN PROCESS CONTROLS AND RELEASE CONTROLS, BOTH MICROBIOLOGICAL (BIOBURDEN, STERILITY TEST, BACTERIAL ENDOTOXINS) AND CHEMICAL (DYNAMIC AND INTRINSIC VISCOSITY, PH, OSMOLALITY, SODIUM HYALURONATE ASSAY) ONES WERE IN COMPLIANCE WITH THE SPECIFICATION. THEREFORE, THE INVESTIGATION PERFORMED DOESN'T SHOW ANY PROBLEM RELATED TO THE QUALITY OF THE PRODUCT AND IBSA EXCLUDES THAT THE ADVERSE EVENT IS RELATED TO AN ANOMALY OR DEFECT IN THE MANUFACTURING PROCESS OF BATCH 2109079". DESPITE SEVERAL FOLLOW-UP ATTEMPTS, NO ADDITIONAL INFORMATION HAS BEEN COLLECTED. IBSA COMMENT (I+FU1+FU2+FU3): THE CASE HAS BEEN INITIALLY EVALUATED AS NON-SERIOUS, UNLISTED AND POSSIBLY RELATED TO THE MEDICAL DEVICE. IT APPEARED TO BE AN EXACERBATION OF KNEE SYMPTOMS ASSOCIATED WITH THE THIRD INJECTION. WITH FOLLOW UP INFORMATION, THE PHYSICIAN CONFIRMED THE DIAGNOSIS OF INFECTION. THE PATIENT WAS HOSPITALIZED, SO THE CASE HAS BEEN UPGRADED TO SERIOUS. ABOUT THE QUALITY, THE MANUFACTURER INVESTIGATIONS MADE ON THE TWO BATCHES HAVE RULED OUT A POTENTIAL PRODUCT DEFECT. SEVERAL FOLLOW-UP ATTEMPTS WERE PERFORMED IN ORDER TO HAVE RESULTS OF JOINT FLUID ASPIRATE AND ADDITIONAL INFORMATION ABOUT THE EVENT OCCURRED. CURRENTLY, THE AVAILABLE DATA DOES NOT ALLOW A PROPER MEDICAL EVALUATION; HOWEVER, BASED ON THE INFORMATION COLLECTED A CONTRIBUTORY ROLE OF GELSYN CANNOT BE EXCLUDED (CAUSALITY: NOT ASSESSABLE).