MAUDE Adverse Event Report: UNKNOWN COPAL G+C; BONE CEMENT, ANTIBIOTIC

Catalog Number 66017790

Device Problem Insufficient Information (3190)

Patient Problem Joint Dislocation (2374)

Event Date 02/25/2021

Event Type  Injury  

Event Description

Clinical adverse event received for tibial dislocation.Event is serious and is considered severe.Event is probably related to both device and procedure.Original implant date on (b)(6) 2020.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: COPAL G+C
• Type of Device: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17528563
• MDR Text Key: 321050721
• Report Number: MW5135494
• Device Sequence Number: 1
• Product Code: MBB
• 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: 03/12/2021

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: 66017790
• Device Lot Number: 94354754
• Patient Sequence Number: 1