MAUDE Adverse Event Report: HERAEUS MEDICAL LLC CEMENT; DISPENSER, CEMENT

Patient Problems Failure of Implant (1924); Pain (1994); Joint Laxity (4526)

Event Date 03/13/2015

Event Type  Injury  

Event Description

Clinical adverse event received for instability, joint effusion, pain (all load related) in left knee, radiolucent lines in x-ray, suspected prothesis loosening.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CEMENT
• Type of Device: DISPENSER, CEMENT
• Manufacturer (Section D): HERAEUS MEDICAL LLC
• MDR Report Key: 17557394
• MDR Text Key: 321400772
• Report Number: MW5144597
• Device Sequence Number: 1
• Product Code: KIH
• 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: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1