MAUDE Adverse Event Report: ZIMMER / SEIKAGAKU CORPORATION, TAKAHAGI PLANT GEL ONE SYRINGE; ACID, HYALURONIC, INTRAARTICULAR

Lot Number 0023J27G

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/11/2024

Event Type  malfunction  

Event Description

Spontaneous communication from (b)(6) reported injection of left knee was initiated but was unable to be completed because the needle popped off syringe during administration.The needle was in patient when it popped off, needle was removed and was intact.No further information provided.Unknown if pt missed a dose, adverse event occurred or if product on hand for return.No further info.Indications: unilateral primary osteoarthritis, left knee; unilateral primary osteoarthritis, right knee.Reported to (b)(6) by: health professional.

• Brand Name: GEL ONE SYRINGE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): ZIMMER / SEIKAGAKU CORPORATION, TAKAHAGI PLANT
• MDR Report Key: 19127875
• MDR Text Key: 340562664
• Report Number: MW5153927
• 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: 04/12/2024

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 Lot Number: 0023J27G
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2024
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male