MAUDE Adverse Event Report: HERAEUS MEDICAL LLC PALACOS R+G BONE CEMENT WITH GENTAMICIN; BONE CEMENT, ANTIBIOTIC

Device Problem Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 08/17/2018

Event Type  malfunction  

Event Description

The cement is palacos r+g bone cement with gentamicin #00-1113-140-01 with lot #8934752 - tempt in operating room 68.4; humidity = 17.8 as per siemens indicator inside the room.Ortho surgeon requested that lot be investigated and removed from supply until cleared.He stated that this has occurred before.Dates of use: (b)(6) 2018.Diagnosis or reason for use: sticky and difficult to manage cement after mixing.

• Brand Name: PALACOS R+G BONE CEMENT WITH GENTAMICIN
• Type of Device: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): HERAEUS MEDICAL LLC
• MDR Report Key: 7809352
• MDR Text Key: 118170525
• Report Number: MW5079335
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1