MAUDE Adverse Event Report: ORTHOVISC INJ 15MG/ML; ACID, HYALURONIC, INTRAARTICULAR

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

Patient Problems Fatigue (1849); Pain (1994); Swelling (2091); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 11/26/2015

Event Type  Injury  

Event Description

Spoke with patient regarding adverse reaction to orthovisc.She stated she wasn't given any warning by the md office that any adverse events could occur.She received 2 out of 3 series injections.First injection was around thanksgiving of 2015.Right after the injection she experienced swelling, fatigue, joint pain, generalized pain (mostly on the right side of body), and intense right knee pain.She didn't report these adverse events to md or return to md the next day because she figured it would go away.She had another appointment in 6 days for her second injections.She went back to md office 6 days later for injection #2 and informed md of the adverse events listed above.Md gave her a steroid injection (patient unaware of which steroid injection) which helped the adverse events.She did not receive the second dose of orthovisc until 1 week post steroid injection.She had the same adverse events listed above but they were intensified.She states she could hardly walk after the second inject and the pain was so intense she was suicidal for 1 week.She again did not report the adverse event to the md until she came in a week later for her third orthovisc injection.Md did not administer the third injection due to the adverse events she experienced.Mdr was unable to give another steroid injection and opted to give the patient an oral tapered steroid blister pak (medrol dosepak).Patient reports that the oral steroid helped but it took months for her to feeling normal again.Patient states that md told her this was the most severe reaction that he has ever seen from orthovisc.Patient states that she still feels like the medication is in her system as of last week.She also wanted to report that she started stem cell therapy for her right knee a few weeks ago and wanted to make us aware as she is not sure if the stem cell therapy could cause her to feel similar effects as the orthovisc did.Dose or amount: orthovisc.Frequency: once weekly.Route: ia.Event abated after use stopped or dose reduced: no.

• Brand Name: ORTHOVISC INJ 15MG/ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• MDR Report Key: 5924642
• MDR Text Key: 53964040
• Report Number: MW5064510
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 59676036001
• UDI-Public: 59676036001
• 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: 08/30/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other