• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY SYNTHES ORTHOVISC ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameORTHOVISC
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
DEPUY SYNTHES
MDR Report Key6785108
MDR Text Key82505445
Report NumberMW5071482
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received08/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/09/2017 Patient Sequence Number: 1
-
-