Description of Event or Problem · 0
THIS SERIOUS SPONTANEOUS REPORT FROM PHYSICIAN RECEIVED FROM BIOVENTUS (REF. NR. COMP-(B)(4)) ON (B)(6) 2022 AS INITIAL REPORT (MERGED WITH FU 1 RECEIVED ON (B)(6) 2022, FU 2 & FU 3 RECEIVED ON (B)(6) 2022 AND FU 4 RECEIVED ON (B)(6) 2022) DESCRIBES THE OCCURRENCE OF INJECTION SITE PAIN, INJECTION SITE SWELLING, RESULTING IN POSITIVE CULTURE ASPIRATE FROM RIGHT KNEE, IN A (B)(6) MALE PATIENT WHO RECEIVED GELSYN-3 (HYALURONATE SODIUM 0.84 %), INJECTION, FOR OSTEOARTHRITIS. PROVIDER ADMINISTERED BILATERAL GELSYN INJECTIONS FOR THE PATIENT ON (B)(6) 2021. PATIENT CALLED 2 DAYS LATER COMPLAINING OF PAIN AND SWELLING IN THE RIGHT KNEE. PATIENT WAS SEEN IN OFFICE ON (B)(6) 2021: THE KNEE WAS ASPIRATED AND SENT FOR CULTURE. CULTURES CAME BACK POSITIVE FOR INFECTION AND PATIENT WAS TAKEN FOR INCISION & DRAINAGE (I&D) OF THE RIGHT KNEE ON (B)(6) 2021. PATIENT WAS PRESCRIBED ORAL ABX (BACTRIM) POST-OP AND DEALT WITH 3-4 MONTHS OF POST-OPERATIVE COMPLICATIONS. HE HAD NO COMPLICATIONS AND COMPLETED THE LEFT KNEE SERIES. PROVIDER RESUMED THE RIGHT KNEE SERIES ON (B)(6) 2022 WHICH THE PATIENT HAS TOLERATED TO THIS POINT AND THE PROVIDER WOULD LIKE AN ADDITIONAL SYRINGE TO COMPLETE THE SERIES FOR THE PATIENT. ADDITIONAL INFORMATION: MULTIPLE ASPIRATION/CULTURES WERE DONE POST-PROCEDURALLY. ALL INFECTION HAS RESOLVED, AND PATIENT WANTED TO RESUME TREATMENT AS HIS PAIN FROM THE OA IS EXTREME. NO FURTHER INFORMATION WAS AVAILABLE. FU1 (B)(6) 2022: THE PHYSICIAN REPORTED THAT GELSYN INJECTION WAS PERFORMED IN THE OFFICE 2 DAYS PRIOR TO THE ONSET OF SYMPTOMS; THE GELSYN BATCH NUMBER WAS 2104005; LATERAL SUPRA-PATELLAR APPROACH WAS USED TO ADMINISTER GELSYN; THE PATIENT'S CURRENT STATUS WAS GOOD, JUST PAIN FROM OSTEOARTHRITIS AT THE TIME OF THE REPORTING OF FOLLOW UP; THE MEDICAL INTERVENTION REQUIRED WAS AN ARTHROSCOPIC I&D OF THE KNEE AND ANTIBIOTIC TREATMENT; NO OTHER RELEVANT MEDICAL CONDITIONS OR PRIOR REACTIONS TO MEDICATIONS WERE KNOWN; THE PATIENT'S DIAGNOSIS WAS OF END STAGE OSTEOARTHRITIS; THE TYPE OF BACTERIA ISOLATED FROM THE INFECTION WAS UNKNOWN; THE SYMPTOMS STARTED 2 DAYS POST INJECTION AND LASTED ABOUT 12 WEEKS; THE 3-4 MONTH POST INJECTION, AS PER MEDICAL RECORDS, THE PATIENT HAD PERSISTENT PAIN, JOINT EFFUSION AND LOSS OF MOTION AND DIMINISHED ABILITY TO PERFORM ADLS FOR A PERIOD OF 2.5-3 MONTHS. FU2 & FU3 ((B)(6) 2022): LABORATORY REPORTS CONFIRMED NO BACTERIA WAS FOUND. LABORATORY RESULTS WERE RECEIVED: BODY FLUID (RIGHT KNEE ASPIRATE) WAS COLLECTED AND ANALYZED ON (B)(6) 2021. THE JOINT FLUID CELL COUNT RESULTED IN: COLOR YELLOW; APPEARANCE TURBID; RBC 14,057/MCL; WBC 16,503 (HIGH; NORMAL VALUE <=150/MCL). THE JOINT FLUID DIFFERENTIAL ANALYSIS RESULTED IN: SEGS (PERCENT SEGMENTED NEUTROPHILS) 85 (HIGH; NORMAL VALUE <25%); LYMPHS 2%; MACROPHAGES 13%. ANAEROBIC CULTURE (NO STAIN) RESULTED IN NO ANAEROBIC GROWTH AT 5 DAYS. BODY FLUID CULTURE (STAIN INCLUDED) RESULTED IN NO GROWTH AT 94 HOURS AND GRAM STAIN SHOWED MODERATE WBCS WITH NO ORGANISMS SEEN. NO FURTHER INFORMATION WAS AVAILABLE. FU4 ((B)(6) 2022): QUALITY INVESTIGATION RESULTS WAS RECEIVED: THE REVIEW OF THE MANUFACTURING AND PACKAGING RECORDS OF BATCH 2104005 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 2104005 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 2104005". IBSA COMMENT (I+FU1+FU2+FU3): SERIOUS, LISTED, POSSIBLE AS CONTRIBUTION DUE TO LACK OF ALTERNATIVE EXPLANATION. THE CAUSAL ROLE OF THE PRODUCT IS LIMITED AS IF THE PRODUCT WAS CONTAMINATED ALSO THE OTHER KNEE WOULD HAVE HAD THE SAME REACTION. BASED ON THE RESULT OF JOINT FLUID ASPIRATE THE DIAGNOSIS IS: PSEUDOSEPTIC REACTION WHICH IS RARE LISTED AE OCCURRENCE RELATED TO THE PROCEDURE/PRODUCT. THEREFORE, THE SERIOUS I&D PROCEDURE AND AB, LOCAL SYMPTOMS 2 DAYS ONSET AND DURATION 12 WEEKS, THE PATIENT HAD PERSISTENT PAIN, JOINT EFFUSION AND LOSS OF MOTION AND DIMINISHED ABILITY TO PERFORM ADLS FOR A PERIOD OF 2.5-3 MONTHS BUT NO SIGNS OF SYSTEMIC SYMPTOMS (FEVER, MALAISE) BECOMES UNRELATED. MANUFACTURER INVESTIGATIONS MADE ON THE BATCH HAVE RULED OUT A POTENTIAL PRODUCT DEFECT. THE LATE, UNCLEAR AND NOT ACCURATE DESCRIPTIONS OF THE EVENTS SINCE OCCURRENCE HAS BEEN RESOLVED".