DUROLANE

Additional Manufacturer Narrative

A PATIENT INJECTED WITH DUROLANE WAS DIAGNOSED WITH SEPTIC ARTHRITIS AND HOSPITALIZED. PATIENT WAS TREATED WITH ANTIBIOTICS (CLINDAMYCINE, CLOXACILLINE) AND MORPHINE. THIS WAS THE PATIENT'S FIRST DUROLANE INJECTION, IN WHICH THEY WERE ALSO INJECTED WITH A STEROID (DOPROSTONE) CONCOMITANTLY. THE PATIENT WAS RELEASED AND IS RECOVERING FROM THE EVENT. A BATCH RECORD REVIEW WAS COMPLETED AND CONFIRMED THIS LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE. A REVIEW OF REPORTED DUROLANE EVENTS IDENTIFIED TWO ADDITIONAL CASES OF INFECTION WITH THE SAME LOT; HOWEVER, ALL THREE CASES WERE FROM THE SAME FACILITY AND THE INJECTIONS PERFORMED BY THE SAME PHYSICIAN ON THE SAME DAY. MULTIPLE FOLLOW-UPS WERE COMPLETED FOR ADDITIONAL INFORMATION, AND ONLY LIMITED INFORMATION WAS PROVIDED AND ALREADY INCLUDED IN THIS REPORT. THIS EVENT WAS REVIEWED BY A CLINICAL SPECIALIST WHO CONCLUDED A ROOT CAUSE COULD NOT BE DETERMINED, AND MOST LIKELY DUE TO THE TREATMENT PROCEDURE. DUROLANE LABELING DOES IDENTIFY INFECTIONS AS A POTENTIAL ADVERSE EVENT WITH THE USE OF THE PRODUCT. BIOVENTUS WILL CONTINUE TO MONITOR THIS AND SIMILAR EVENTS SHOULD ADDITIONAL ACTION BE NEEDED.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT BEING TREATED FOR MODERATE GONARTHROSIS OF THE KNEE WAS INITIALLY INJECTED ON (B)(6) 2025, CONCOMITANTLY WITH DUROLANE AND A STEROID INJECTION. IT WAS REPORTED THE PHYSICIAN USED THE SAME NEEDLE FOR THE DUROLANE INJECTION THAT WAS UTILIZED FOR THE STEROID INJECTION. THREE DAYS POST INJECTION, THE PATIENT EXPERIENCED SEVERE PAIN AND SWELLING AND WAS HOSPITALIZED. A JOINT PUNCTURE WAS COMPLETED FOR BACTERIAL SAMPLING. THE PATIENT WAS DIAGNOSED WITH SEPTIC ARTHRITIS CAUSED BY STAPHYLOCOCCUS AUREUS. PATIENT WAS PROVIDED ONE INTRAVENOUS AND TWO ORAL ANTIBIOTICS AS WELL AS MORPHINE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2025 IN STABLE CONDITION. PATIENT IS REPORTED TO STILL HAVE PAIN BUT IS IMPROVING.