MAUDE Adverse Event Report: ZIMMER/BIOMET GEL-ONE INJ 30MG/3ML; ACID HYALURONIC

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 01/25/2018

Event Type  Injury  

Event Description

Pt 2 weeks out from injections and reported decreased in function in knees.Still having pain and feels like knees have hardened.Advised no refund available for therapy issue.Discussed expectations from therapy and possible treatment failure may have occurred.Directed mbr back to dr and possible alternative to gel-one may be needed.Rph.

• Brand Name: GEL-ONE INJ 30MG/3ML
• Type of Device: ACID HYALURONIC
• Manufacturer (Section D): ZIMMER/BIOMET
• MDR Report Key: 7244559
• MDR Text Key: 99246130
• Report Number: MW5075079
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR