Description of Event or Problem · 0
RIGHT KNEE INFECTION [INFECTION] . CASE NARRATIVE: THIS IS A SERIOUS SPONTANEOUS CASE RECEIVED FROM A HEALTH PROFESSIONAL IN THE UNITED STATES. THIS REPORT CONCERNS A 60-YEAR-OLD FEMALE WHO EXPERIENCED RIGHT KNEE INFECTION DURING TREATMENT WITH EUFLEXXA (SODIUM HYALURONATE) SOLUTION FOR INJECTION UNKNOWN CONCENTRATION, DOSE, ROUTE, AND FREQUENCY, FOR UNKNOWN INDICATION FROM (B)(6) 2023 TO AN UNKNOWN STOP DATE. THE X-RAY TECHNOLOGIST REPORTED THAT THE PATIENT RECEIVED A EUFLEXXA INJECTION IN THE LEFT KNEE ON (B)(6) 2023 AND THEN RECEIVED A EUFLEXXA INJECTION IN HER RIGHT KNEE ON (B)(6) 2023. THE PATIENT WAS HOSPITALIZED OVER THE WEEKEND DUE TO A RIGHT KNEE INFECTION WHICH WAS WASHED OUT ON (B)(6) 2023. LOT NUMBER 030073 WITH EXPIRATION DATE OF 12-AUG-2024 WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED. ACTION TAKEN WITH EUFLEXXA WAS UNKNOWN. CONCOMITANT MEDICATION AND MEDICAL HISTORY WERE NOT REPORTED. ALL EVENTS IN THE CASE WERE REPORTED AS SERIOUS. AT THE TIME OF REPORTING THE CASE OUTCOME WAS UNKNOWN. SENDER COMMENT: AS VERY LIMITED INFORMATION REGARDING E.G. PRODUCT INDICATION AND MEDICAL HISTORY WAS PROVIDED, IT IS DIFFICULT TO PERFORM A THOROUGH MEDICAL EVALUATION. DUE TO CLINICAL INTERPRETATION IN ALIGNMENT WITH KNOWN SAFETY PROFILE, COMPANY CAUSALITY IS CONSIDERED RELATED TO EUFLEXXA. IT CAN NOT BE RULED OUT THAT THE INFECTION IN RIGHT KNEE WAS OCCURRING POST INJECTION OF EUFLEXXA. OVERALL LISTEDNESS (CORE LABEL) IS UNLISTED. REPORTER CAUSALITY: RELATED. COMPANY CAUSALITY: RELATED. OTHER CASE NUMBERS: INTERNAL # - OTHERS = FMC-EVENT-001377. INTERNAL # - OTHERS = FMC-CASE-005575. THIS AE OCCURRED IN UNITED STATES AND CONCERNS THE MEDICAL DEVICE EUFLEXXA. PLEASE REPORT TO YOUR LOCAL HEALTH AUTHORITY IF REQUIRED BY LOCAL LAW. THIS AE IS NOT REPORTABLE IN EU BECAUSE IT DOES NOT MEET THE DEFINITION OF A MEDICAL DEVICE INCIDENT ACCORDING TO THE REQUIREMENTS OF THE MDD (EUROPEAN COUNCIL DIRECTIVE OF (B)(6) 1993 93/42/EEC CONCERNING MEDICAL DEVICES) / MDR (EU) 2017/745 AND/OR BECAUSE IT DID NOT OCCUR IN AN EU + EFTA COUNTRY + TR AND NI AND DID NOT RESULT IN A CORRECTIVE ACTION BY THE MANUFACTURER. NO CORRECTIVE ACTION WAS DONE BY THE MANUFACTURER OR REQUESTED BY REGULATORS.