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

Device Problem Patient Device Interaction Problem (4001)

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

Event Date 11/02/2022

Event Type  Injury  

Event Description

A 56 y.O.Female with past medical history significant for bilateral primary osteoarthritis of the knees and patent foramen ovale, who presented to (b)(6) emergency department with complaint of left knee swelling only several hours after having a synvisc injection into both knees.She has underwent synvisc injections numerous times in the past and has tolerated well.However she noticed that the left knee was more swollen this time, and she was having difficulty bearing weight on the knee due to pain.She denies any fevers or chills.On admission, there is concern for septic arthritis due to 87% neutrophils on synovial fluid analysis (42,550 total nucleated cells), many wbcs on gram stain, but no organisms.Synovial fluid culture has been sent.Orthopedic surgery has been consulted.Optimize pain control.Continue empiric iv vancomycin and ciprofloxacin.Discharge: both of them agree and feel that he would be very rare to have a septic arthritis only several hours after the injection and her laboratory markers are not convincing of septic arthritis either.Their recommendation was to discharge her home today, on keflex, and have her follow-up with dr.(b)(6) on (b)(6) 2022 as previously scheduled.

• Brand Name: SYNVISC HYLAN
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 16427577
• MDR Text Key: 310165291
• Report Number: MW5115109
• 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: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/17/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White