FDA Adverse Event Summary report: N

SYNVISC (HYLAN G-F 20) INJECTION

MDR report key: 1081510 · Received July 25, 2008

Report

Report Number
2246315-2008-00107
Date Received
July 25, 2008
Report Date
July 21, 2008
Manufacturer
GENZYME BIOSURGERY (RIDGEFIELD)
Product Code
MOZ
PMA / PMN Number
P940015
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
FR
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

FUNCTIONAL IMPAIRMENT: [MOBILITY DECREASED]. INFLAMMATORY REACTION OF THE KNEE: [ARTHRITIS]. KNEE EFFUSION: [JOINT EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT REC'D ON 21-JUL-2008 FROM A PHYSICIAN REGARDING A (B) (6) MALE PT. (B) (6). THE PT'S RELEVANT MEDICAL HISTORY INCLUDES STAGE 3 OSTEOARTHRITIS AND ONE PRIOR SYNVISC SERIES. ON AN UNSPECIFIED DATE, AFTER RECEIVING HIS SECOND INJECTION OF SYNVISC (SECOND SERIES), THE PT EXPERIENCED A VERY INTENSIVE KNEE INFLAMMATORY REACTION WITH EFFUSION LEADING TO FUNCTIONAL IMPAIRMENT. THE PHYSICIAN PRESCRIBED AN UNSPECIFIED ORAL CORTICOSTEROID, AND USED OF ICE ON HIS KNEE WAS ADVISED. THE REPORTED EVENTS LASTED FOR 1 WEEK. THE THIRD SYNVISC INJECTION WAS ADMINISTERED 10 DAYS LATER TOGETHER WITH AN INJECTION OF DIPROSTENE (BETAMETHASONE) IN HIS KNEE. NO ADVERSE EVENTS OCCURRED AFTER THE THIRD INJECTION. AS OF THE DATE OF RECEIPT OF THIS REPORT THE PT OUTCOME WAS RECOVERED. THE PHYSICIAN DID NOT ASSESS THE RELATIONSHIP BETWEEN THE REPORTED EVENTS AND SYNVISC.

Devices

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

Patients

Seq Age Sex Outcome Treatment
1 73 YR Other