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

Model Number HYLAN G-F 20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Pain (1994); Swelling/ Edema (4577)

Event Date 05/14/2013

Event Type  Injury  

Event Description

A (b)(6) male with pmh significant for osteoarthritis received hylan g-f (synvisc) 48mg/6ml injection in both knees on (b)(6) 2013.Patient contacted primary care clinic (b)(6) 2013 with complaints of right knee pain and swelling post injection.Patient was seen by rheumatologist who performed injections and right knee arthrocentesis completed.12cc of fluid removed from right knee.Patient instructed to continue naproxen for pain/ inflammation and return to clinic 3 days later for f/u.Patient reported to ed over the weekend, (b)(6) 2013, with recurrent swelling and pain.Arthrocentesis completed in ed produced-100cc of fluid.Patient was sent home from ed with prn oxycodone/apap.F/u with rheumatologist (b)(6) 2013, showed continued swelling of knee joint.Naproxen stopped and etodolac started.F/u with rheumatologist (b)(6) 2013 states improvement in knee swelling but continued knee pain despite trail of multiple nsaids.Patient was referred to orthopedics for further treatments options.Scheduled for ortho f/u (b)(6) 2013.Symptoms: pseudoseptic reactions; suspect during # 1 dosing: inject the contents of one syringe (48 mg) intra - articularly once for procedure to affected knee(s) to reduce pain.

• Brand Name: SYNVISC
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 10811035
• MDR Text Key: 215609922
• Report Number: MW5097715
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 08/02/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: HYLAN G-F 20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/06/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 40