MAUDE Adverse Event Report: ZIMMER BIOMET BONE CEMENT

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 09/28/2020

Event Type  malfunction  

Event Description

Clinical adverse event received for crepitus.Event is not serious and is considered mild.Probably related to both device and procedure.Original implant date (b)(6) 2019.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BONE CEMENT
• Type of Device: BONE CEMENT
• Manufacturer (Section D): ZIMMER BIOMET
• MDR Report Key: 17524855
• MDR Text Key: 321407000
• Report Number: MW5131798
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1