FDA Adverse Event Injury Summary report: N

EUFLEXXA

MDR report key: 2123431 · Received October 29, 2008

Report

Report Number
2244564-2008-00146
Event Type
Injury
Date Received
October 29, 2008
Date of Event
August 1, 2008
Report Date
September 19, 2008
Manufacturer
BIO-TECHNOLOGY GENERAL (ISRAEL) LTD
Product Code
MOZ
PMA / PMN Number
P010029
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
TX, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

PATIENT (B)(6) IS A (B)(6) HYPERTENSIVE DIABETIC WITH A MENISCAL TEAR OF HIS LEFT KNEE. HE HAD BEEN TREATED SUCCESSFULLY WITH A SERIES OF 3 EUFLEXXA INJECTIONS PRIOR TO ARTHROSCOPIC SURGERY. AT ARTHROSCOPY, THE TEAR WAS CONFIRMED AND OA WAS ALSO DIAGNOSED. POST-OP, IT WAS DECIDED TO TREAT HIM AGAIN WITH EUFLEXXA TO INCREASE THE INTERNAL KNEE VISCOSITY, AS AN ALTERNATIVE TO SURGICAL REPAIR. HE REC'D 3 INTRA-ARTICULAR EUFLEXXA INJECTIONS, THE LAST ON (B)(6) 2008 AND APPEARED TO BE DOING WELL. ON (B)(6) 2008, HE DEVELOPED FEVER, CHILLS, PAIN AND SWELLING IN HIS LEFT KNEE. ABOUT 80 ML CLOUDY, YELLOW, VISCOUS FLUID WAS ASPIRATED FROM HIS KNEE. STAPH SPECIES (NOT AUREUS) WAS CULTURED FROM THE FLUID. A DIAGNOSIS OF SEPTIC ARTHRITIS WAS MADE. HE WAS ADMITTED TO THE HOSPITAL AND FURTHER OPERATION ROOM ARTHROSCOPY WAS PERFORMED ON (B)(6) 2008, WHEN THE KNEE WAS IRRIGATED. IT SHOULD BE NOTED THAT SKIN PREP INVOLVED A 3 SWAB TECHNIQUE, AND THE WHOLE PROCEDURE WAS CONDUCTED UNDER STERILE CONDITIONS. HE REMAINED IN HOSPITAL FOR 4-5 DAYS ON IV AND LATER ORAL ANTIBIOTICS. HE REC'D PHYSICAL THERAPY, AND PROGRESSED FROM A WHEELCHAIR, TO 2 CRUTCHES AND EVENTUALLY TO A CANE. HE HAS NOW MADE A COMPLETE RECOVERY. CAUSALITY IS "POSSIBLE", BUT NOT NUMBER IS NOT AVAILABLE AND VIAL IS NOT AVAILABLE FOR TESTING.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 EUFLEXXA 1% SODIUM HYALURONATE MOZ BIO-TECHNOLOGY GENERAL (ISRAEL) LTD

Patients

Seq Age Sex Outcome Treatment
1 61 YR Hospitalization