MAUDE Adverse Event Report: GENZYME CORP. HYLAN G-F 20; SYNVISC-ONE

Lot Number Q13121

Device Problem No Apparent Adverse Event (3189)

Patient Problems Discomfort (2330); Arthralgia (2355); Joint Swelling (2356)

Event Date 10/09/2014

Event Type  Injury  

Event Description

This sae describes 3 separate aes for the same pt.All of the aes occurred for the same reason with the same known reaction where each reaction was increasingly worse in severity.The pt received their first injection of the ide therapy synvisc-one for relief from pain due to knee osteoarthritis on (b)(6) 2012 and did not report any symptoms.Upon their second injection on (b)(6) 2013, the pt reported the known reaction of swelling, pain, and inability to walk, at which point he was advised by the study physician to stay off his leg, and the issue resolved.The pt requested a third injection 6 months later and again experienced swelling to the degree that he had to be on crutches for 1 week.His symptoms resolved and he did not complain further.The pt requested a fourth injection, after which he reported the most severe reaction to date, which again resolved itself.At this point the study physician communicated to the pt that due to this trend in reactions, he will not receive any further injections.We continue to follow and monitor the pt, however, if the requests another injection, he will be excluded from further study participation.

• Brand Name: HYLAN G-F 20
• Type of Device: SYNVISC-ONE
• Manufacturer (Section D): GENZYME CORP.; framingham MA
• MDR Report Key: 4426035
• MDR Text Key: 5281521
• Report Number: 4426035
• Device Sequence Number: 1
• Product Code: MOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2016
• Device Lot Number: Q13121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/14/2014
• Distributor Facility Aware Date: 10/09/2014
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/14/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Weight: 77