MAUDE Adverse Event Report: ZIMMER, INC. BONE CEMENT

Device Problem Insufficient Information (3190)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 11/15/2021

Event Type  Injury  

Event Description

Clinical adverse event received for heart failure.Event is not serious and is considered moderate.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2021 date of event: (b)(6) 2021 (right knee).Treatment: diagnostic intervention complaint number: (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, INC.
• MDR Report Key: 17488494
• MDR Text Key: 320682553
• Report Number: MW5121193
• 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: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1