MAUDE Adverse Event Report: ZIMMER SURGICAL INC PALACOS BONE CEMENT WITH GENTAMYCIN; BONE CEMENT WITH ANTIBIOTIC

Lot Number 82064447

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/03/2018

Event Type  malfunction  

Event Description

When applying cement into the patient's knee for total knee arthroplasty, the surgeon removed what appeared to by an eyelash within the cement.The staff involved in preparing the cement were all wearing ortho "hoods" which completely contain hair.The surgeon believes that the eyelash came from someone during the manufacturing process.

• Brand Name: PALACOS BONE CEMENT WITH GENTAMYCIN
• Type of Device: BONE CEMENT WITH ANTIBIOTIC
• Manufacturer (Section D): ZIMMER SURGICAL INC; 56 east bell dr.; warsaw IN 46581
• MDR Report Key: 8447618
• MDR Text Key: 139693257
• Report Number: 8447618
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 82064447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/20/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1