MAUDE Adverse Event Report: ZIMMER, INC. REFOBACIN BONE CEMENT; BONE CEMENT, ANTIBIOTIC

Lot Number 13CA12607

Patient Problem Pain (1994)

Event Date 01/30/2024

Event Type  Injury  

Event Description

Clinical adverse event received for anterior knee pain.Event is not serious and is considered mild.Event is possibly related to both device and procedure.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: REFOBACIN BONE CEMENT
• Type of Device: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): ZIMMER, INC.
• MDR Report Key: 18876982
• MDR Text Key: 337576250
• Report Number: MW5152588
• 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: Unknown
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 13CA12607
• Patient Sequence Number: 1