MAUDE Adverse Event Report: ORTHOVISC; PER ACMINISTRATOR

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Disability (2371)

Event Date 09/12/2014

Event Type  Injury  

Event Description

Orthovisc was recommended to me to ease the knee pain related to osteoarthritis.I received 4 total injections administered by a professional.When asked how effective the shots had been, my common reply was i had felt little improvement.Upon 4th visit to doctor, when asked same, i said i had felt no improvement, as matter of fact i remarked that my condition seemed worse.I had so much knee pain, i requested a medication to relieve the pain.The doctor recommended an additional shot.My condition has worsened.I cannot get up with assistance or pushing myself up (for example) with some kind of arm chair, pushing myself up with my hand rested on the seat of my chair and using table edge with other hand for boost.Further, i cannot sit down in a chair without some physical assistance.I question if anything i am suffering will be relieved or if my problems can be solved.I am afraid of being permanently disabled.I believe something went really wrong.I had to purchase a booster chair (with arms) to get up and down on the toilet, i take excedrin extra strength and ibuprofen for pain reliefs.The doctor administering the orthovisc was negligent in getting back to me to give me something for pain, it took several calls to resolve the problem.Please respond to my e-mail asap with any suggestions you might have.I do have one further comment.My husband has severe copd and cancer.I am his care giver and it has been difficult for me at times.Dates of use: (b)(6) 2014.

• Brand Name: ORTHOVISC
• Type of Device: PER ACMINISTRATOR
• MDR Report Key: 4379860
• MDR Text Key: 5266146
• Report Number: MW5039881
• Device Sequence Number: 1
• Product Code: MOZ
• 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: 12/29/2014

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: Other
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 77 YR
• Patient Weight: 79