FDA Adverse Event Summary report: N

SYNVISC (HYLAN G-F 20) INJECTION

MDR report key: 1834108 · Received September 8, 2010

Report

Report Number
2246315-2010-00179
Date Received
September 8, 2010
Date of Event
March 4, 2010
Report Date
September 3, 2010
Manufacturer
GENZYME BIOSURGERY (RIDGEFIELD)
Product Code
MOZ
PMA / PMN Number
P940015
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
MX
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

INFECTION IN KNEE [ARTHRITIS INFECTIVE]; KNEE EFFUSION [JOINT EFFUSION]. CASE DESCRIPTION: A SPONTANEOUS REPORT WAS REC'D ON 03-SEP-2010 FROM THE HCP OF A (B)(6) MALE PT WITH A HISTORY OF GRADE II OSTEOARTHRITIS OF THE KNEES, (B)(6), WHO HAD AN INFECTION IN THE KNEE AFTER STARTING SYNVISC. THE PT'S HCP REPORTED THE FOLLOWING: ALONG WITH OSTEOARTHRITIS, THE PT HAS A HISTORY OF POSTTRAUMATIC LEFT TESTICLE SURGERY, BILATERAL CLAVICLE FRACTURE, BILATERAL WRIST FRACTURE, LEFT ANKLE PENETRATING INJURY, GASTRITIS TREATED WITH RANITIDINE, AND NO ALLERGIES. THE PT HAS HAD PAIN IN HIS RIGHT KNEE WITH TWO YEARS IN EVOLUTION. ON (B)(6) 2009, THE PT PRESENTED WITH PERSISTENT PAIN IN BOTH KNEES BUT WITH PREDOMINANCE IN THE LEFT KNEE. THE PT WAS TREATED WITH DIPROSPAN. THE PT WAS SCHEDULED TO RETURN FOR EVALUATION. ON (B)(6) 2010, THE PT WAS GIVEN THE FIRST INJECTION OF THE THREE SERIES SYNVISC WITHOUT ANY INCIDENT. THE PT WAS ALSO PRESCRIBED CELEBREX, ATRIDOL GEL, TYLEX AND WAS ASKED TO FOLLOW SOME PHYSICAL MEASURES. ON (B)(6) 2010, THE PT WAS GIVEN THE SECOND INJECTION OF SYNVISC WITHOUT ANY INCIDENT. ON (B)(6) 2010, TWO DAYS AFTER THE SECOND INJECTION, THE PT EXPERIENCED A 1 CM INCREASE IN THE SUPRA PATELLAR RECESS AND INCREASED BILATERAL PARATENON. THE KNEE FLEXION WAS LIMITED TO 90 DEGREES. ARTHROCENTESIS WAS PERFORMED AND 25 CC YELLOW LIQUID WAS SENT TO THE LABORATORY FOR ANALYSIS. ONE VIAL OF NEURALIN WAS ADMINISTERED INTRAMUSCULARLY EVERY THREE DAYS; AND THE PT WAS PRESCRIBED ELEQUINE TABLETS 500 MG FOR 7 DAYS; TRADOL CRYOTHERAPY; BANDAGE AND REST. THE LAB RESULTS WERE AS FOLLOWS: THE LEFT KNEE ARTHROCENTESIS LIQUID TESTED POSITIVE FOR GRAM POSITIVE COCCI. THE FLUID WAS YELLOW AND MURKY, PH 9.0, DENSITY 1,035, PANDY REACTIVE, GLUCOSE 71 MG/DL, TOTAL PROTEINS 6100 MG/DL, SODIUM 100 MEQ/L, POTASSIUM 5 MEQ/L, CHLORIDE 50 MEQ/L, LACTIC DEHYDROGENASE 2217.77 U/L, URIC ACID 6.07 MG/DL, LEUKOCYTES 350MM3, ERYTHROCYTES 0MM3, MONONUCLEAR CELLS 75%, POLYMORPHONUCLEAR CELLS 19%, 6% CELLS WERE OBSERVED. ON (B)(6) 2010, THE KNEE WAS WITHOUT EVIDENCE OF INFECTION AND WAS BEING TREATED WITH TRADOL, DICLOFENAC, AND NEURALIN THIRD DOSE ON THAT DAY. THE PT DID NOT RETURN TO RECEIVE THE THIRD INJECTION OF SYNVISC.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SYNVISC (HYLAN G-F 20) INJECTION INTRA-ARTICULAR HYALURONIC ACID MOZ GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

Patients

Seq Age Sex Outcome Treatment
1 79 YR Other CELEBREX (CELECOXIB)| ARTRIDOL (BETAMETHASONE,INDOMETACIN,METHOCARBAMOL)| TYLEX (PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE)