MAUDE Adverse Event Report: ZIMMER, INC. GEL ONE SYRINGE; ACID, HYALURONIC, INTRAARTICULAR

Lot Number 022B16G

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Indication - unilateral primary osteoarthritis, left knee.Spontaneous call.Patient reports that when her doctor's office tried to give her the gel-one injection, a lot of the medication squirted out and the doctor's office told her that she did not get the full dose.Unknown if any adverse event occurred.Unknown if patient missed the dose.Unknown if product is available for return.Reported to (b)(6) by pt/caregiver.

• Brand Name: GEL ONE SYRINGE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw ID 46580
• MDR Report Key: 15362515
• MDR Text Key: 299371750
• Report Number: MW5111861
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 05/09/2024
• Device Lot Number: 022B16G
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2022
• Patient Sequence Number: 1
• Patient Sex: Female