MAUDE Adverse Event Report: DEPUY SYNTHES ORTHOVISC ; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Insufficient Information (3190)

Patient Problems Arrhythmia (1721); Stroke/CVA (1770)

Event Date 07/17/2017

Event Type  Injury  

Event Description

Received 3 rounds of orthovisc knee injections at (b)(6) 2016.Within one week, started having severe heart arrythmias.Had a previous history of arrythmia and svt, but my heart dr said it was never consistent enough to treat it.After the knee injections, i visited my heart dr with the increased symptoms.He wanted me to wear a heart monitor for one month.After one week, his office called and said they had all the info they needed, had me return to his office and scheduled a heart ablation for 3 months out.Heart ablation happened in (b)(6) and was unsuccessful.Three and a half months later, i had a stroke on (b)(6) and was hospitalized for 4 days.All tests came back negative for any explanations.As of yet, there is no explanation for my stroke.I am (b)(6), not overweight and in pretty good health.I exercise 3 times a week.I am on blood pressure daily for hypertension and it is well controlled.I still have to f/u with my pcp and neurologist next week, at which time i will discuss the possible link between the orthovisc injection and my stroke.I just had such a huge health change with my heart within days of getting the orthovisc injections, that i truly believe that this is all related to that.I did mention it to my heart dr and of course he just noted it and would not discuss it with me.There must be some "code of ethics" between doctors that keeps them from doing that.I will get to the bottom of it, unless it kills me first.Injected in the knee joint, once weekly/ 3 wks.Dates of use: (b)(6) 2016.Osteo arthritis in the knees.

• Brand Name: ORTHOVISC
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): DEPUY SYNTHES
• MDR Report Key: 6785108
• MDR Text Key: 82505445
• Report Number: MW5071482
• 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: Patient
• Type of Report: Initial
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Disability
• Patient Age: 47 YR
• Patient Weight: 64