MAUDE Adverse Event Report: ZIMMER, INC. HERAEUS MEDICAL PALACOS R+G BONE CEMENT; KNEE PROSTHESIS

Catalog Number 00111314001

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Pain (1994); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

Information was received from a health professional who is not required to complete form 3500a.This bone cement is manufactured at (b)(4) and distributed through (b)(4).Device history records were reviewed and identified no deviations or anomalies.No devices were received; therefore the condition of the components is unknown.This device is used for treatment.A complaint history review was performed for the devices involved and identified no additional complaints.It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.A definitive root cause cannot be determined with the information provided.

Event Description

It is reported that the patient is experiencing pain, swelling and loosening following knee arthroplasty.A revision surgery has been scheduled.

• Brand Name: HERAEUS MEDICAL PALACOS R+G BONE CEMENT
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: carrie schneider ; p.o. box 708; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 5987843
• MDR Text Key: 55947294
• Report Number: 0001822565-2016-03465
• 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: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00111314001
• Device Lot Number: 78904387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other