MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GEL-ONE; BIOLOGICS

Model Number N/A

Device Problem Defective Component (2292)

Patient Problem Pain (1994)

Event Date 06/25/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Discarded.

Event Description

It was reported that during a gel-one procedure, the blue flange broke off causing the provider¿s hand to slip with more force downward thus causing the needle to bend in the patient¿s joint.The patient complained of additional pain as a result of this malfunction.

Manufacturer Narrative

The initial report was forwarded in error and should be voided.

Event Description

No further event information available at the time of this report.

• Brand Name: GEL-ONE
• Type of Device: BIOLOGICS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8799128
• MDR Text Key: 151333858
• Report Number: 0001825034-2019-02882
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNK GEL ONE SYRINGE
• Device Lot Number: 0019C20G
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other