MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PALACOS R+G BONE CEMENT

Model Number N/A

Device Problems Loss of or Failure to Bond (1068); Malposition of Device (2616)

Patient Problems Foreign Body Reaction (1868); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.

Event Description

It was reported a patient is experiencing loosening of a plate, "off center" plate, metallosis, and radiolucent lines.No revision has been reported to date.No further information has been made available at this time.

Event Description

It was reported a patient is experiencing loosening of a plate, "off center" plate, metallosis, and radiolucent lines.Additional information received indicates patient underwent scans which revealed lucency and particle disease in the right knee.Patient has also been experiencing pain.A future revision procedure has been indicated; however, no revision has been reported to date.

Manufacturer Narrative

Case # (b)(4).Reporter indicated that product is been received by legal department on february 2, 2018.

• Brand Name: PALACOS R+G BONE CEMENT
• Type of Device: BONE CEMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6969152
• MDR Text Key: 89970602
• Report Number: 0001822565-2017-07348
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK142157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00111314001
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other