MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC-ONE; ACID, HYALURONIC, INTRAARTICULAR

Model Number HYLAN G-F-20

Device Problem Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Arthralgia (2355)

Event Date 12/12/2017

Event Type  malfunction  

Event Description

Patient received an ultrasound guided injection of synvisc-one.Patient presented with left knee pain and reports stabbing pain began at approximately 16:00 that same day (approximately 8 hours post injection).Growth of a gram negative bacillus was detected from the synovial fluid culture collected.Manufacturer has issued a recall.

• Brand Name: SYNVISC-ONE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION; 1125 pleasantview terrace; ridgefield NJ 07657
• MDR Report Key: 7326973
• MDR Text Key: 101993136
• Report Number: 7326973
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HYLAN G-F-20
• Other Device ID Number: P940015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/16/2018
• Date Report to Manufacturer: 02/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTHER, PATIENT RECEIVED AN ULTRASOUND GUIDED INJ
• Patient Outcome(s): Other