MAUDE Adverse Event Report: ZIMMER, INC. BONE CEMENT

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 03/18/2021

Event Type  Injury  

Event Description

Clinical adverse event received for right knee pain.Event is not serious and is considered mild.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2021 date of event: (b)(6) 2021 (right knee).Treatment: oral medication and physical therapy 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: 17488487
• MDR Text Key: 320682622
• Report Number: MW5121186
• 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