MAUDE Adverse Event Report: ZIMMER BIOMET OPTIPAC CEMENT; BONE CEMENT

Catalog Number 47105003941

Device Problem Insufficient Information (3190)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/12/2020

Event Type  malfunction  

Event Description

Clinical notification received for revision of implant.(unknown knee).(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: OPTIPAC CEMENT
• Type of Device: BONE CEMENT
• Manufacturer (Section D): ZIMMER BIOMET
• MDR Report Key: 17537370
• MDR Text Key: 321441625
• Report Number: MW5144249
• 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: 01/31/2022

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
• Device Catalogue Number: 47105003941
• Device Lot Number: A714O07270
• Patient Sequence Number: 1