SYNVISC ONE (HYLAN G-F 20) INJECTION

MDR report key: 2851110 · Received November 16, 2012

Report

Report Number: 2246315-2012-00352
Event Type: Other
Date Received: November 16, 2012
Date of Event: July 19, 2012
Report Date: November 9, 2012
Manufacturer: GENZYME BIOSURGERY (RIDGEFIELD)
Product Code: MOZ
PMA / PMN Number: PMA P940015
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THIS REPORT.

Description of Event or Problem · 1

POST-INJECTION PAIN TO THE RIGHT KNEE (ARTHRALGIA). RIGHT KNEE INFLAMMATION (ARTHRITIS). RIGHT KNEE REDNESS (ERYTHEMA). RIGHT KNEE SWELLING (JOINT SWELLING). CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012 FROM A PHYSICIAN REGARDING A MALE PATIENT, AGE AND INITIALS NOT PROVIDED. THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. ON (B)(6) 2012, THE PATIENT INITIATED TREATMENT WITH INTRA-ARTICULAR SYNVISC ONE (HYLAN G F 20) INJECTION IN BOTH KNEES (DOSAGE REGIMEN NOT PROVIDED). THE LOT NUMBER FOR SYNVISC WAS NOT PROVIDED. THE SAME DAY, THE PATIENT EXPERIENCED POST-INJECTION PAIN, INFLAMMATION, REDNESS AND SWELLING IN RIGHT KNEE. ON AN UNSPECIFIED DATE IN 2012, THE PATIENT RECEIVED CORTISONE TO TREAT THE PAIN. SYNVISC ONE DOSE WAS UNCHANGED. THE OUTCOME FOR ALL THE EVENTS WAS NOT PROVIDED. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY FOR ALL THE EVENTS WAS NOT PROVIDED. THE RELATIONSHIP BETWEEN SYNVISC ONE AND ALL THE EVENTS WAS NOT PROVIDED BY THE REPORTING PHYSICIAN.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Required Intervention