MAUDE Adverse Event Report: ZIMMER BIOMET GEL ONE STRENGTH 30 MG

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Burning Sensation (2146); Reaction (2414); Ambulation Difficulties (2544)

Event Date 07/17/2017

Event Type  Injury  

Event Description

Pt had severe reaction/side effects from gel one injection, she was in extreme pain after that shot.She had burning and stinging pain in both knees.Pt mentioned she could not walk since then, she is still having pains and issues walking.Pt had talked to mdo about it then and have been getting steroidal shot for pain.Dates of use: (b)(6) 2017.Diagnosis or reason for use: m17.0.

• Brand Name: GEL ONE STRENGTH 30 MG
• Type of Device: GEL ONE STRENGTH 30 MG
• Manufacturer (Section D): ZIMMER BIOMET
• MDR Report Key: 7199872
• MDR Text Key: 97650429
• Report Number: MW5074611
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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: 64 YR