SYNVISC ONE (HYLAN G-F 20) INJECTION

Report

Report Number: 2246315-2011-00002
Event Type: Other
Date Received: January 6, 2011
Date of Event: December 1, 2010
Report Date: December 30, 2010
Manufacturer: GENZYME BIOSURGERY (RIDGEFIELD)
Product Code: MOZ
PMA / PMN Number: P940015
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

MFR'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THE REPORT. EVAL SUMMARY: THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH RECORD REVIEW IS NOT POSSIBLE. IT IS THE REQUIREMENT TO REVIEW ALL FINISHED BATCH RECORDS FOR SPECIFICATION CONFORMANCE PRIOR TO RELEASE. ANY OUT OF SPECIFICATION RESULT IS IDENTIFIED AND MITIGATED. DATA IS PERIODICALLY PRESENTED AND REVIEWED BY INDIVIDUALS RESPONSIBLE FOR ASSURING PRODUCT QUALITY. THIS REVIEW HAS NOT INDICATED TRENDS THAT COULD BE ASSOCIATED WITH ANY PRODUCT COMPLAINT. GENZYME WILL CONTINUE TO MONITOR COMPLAINTS.

Description of Event or Problem · 1

INTENSE LEFT KNEE PAIN [ARTHRALGIA]. HARD TO WALK [GAIT DISTURBANCE]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2010, FROM A CONSUMER REGARDING A (B)(6) FEMALE PT, INITIALS (B)(6), WITH A MEDICAL HISTORY OF OSTEOARTHRITIS. THE PT DID NOT HAVE PREVIOUS TREATMENT WITH SYNVISC-ONE. THE PT WAS ADMINISTERED SYNVISC-ONE ON (B)(6) 2010, IN THE LEFT KNEE. THREE MONTHS AFTER RECEIVING THE SYNVISC-ONE INJECTION, THE PT EXPERIENCED INTENSIVE LEFT KNEE PAIN WHICH MADE IT HARD TO WALK. TREATMENT INCLUDED AN INTRA-ARTICULAR CORTISONE KNEE INJECTION, ALEVE (NAPROXEN SODIUM), TRAMADOL, AND A CANE. THE SYNVISC-ONE LOT NUMBER WAS UNK. NO FURTHER INFO WAS PROVIDED.

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	91 YR		Required Intervention