MAUDE Adverse Event Report: DEPUY SYNTHES / ANIKA THERAPEUTICS, INC. ORTHOVISC INJECTION; ACID, HYALURONIC, INTRAARTICULAR

Device Problems Patient-Device Incompatibility (2682); Appropriate Term/Code Not Available (3191)

Patient Problems Swelling (2091); No Code Available (3191)

Event Date 02/03/2020

Event Type  Injury  

Event Description

Received an orthovisc injection in left knee.My whole leg swelled, was drained twice, then had an orthoscopic cleaning and an over night hospital stay.Still having bad knee problems to this date worsened.Tests were done looking for infection or clots.

• Brand Name: ORTHOVISC INJECTION
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): DEPUY SYNTHES / ANIKA THERAPEUTICS, INC.
• MDR Report Key: 10918587
• MDR Text Key: 218920146
• Report Number: MW5098109
• 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: Patient
• Type of Report: Initial
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 73 YR
• Patient Weight: 51