MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. ANTHEM; ANTHEM TI LATERAL NARROW DISTAL FEMUR PLATE, LEFT, 11 HOLE, 267MM

Model Number 1195.1211

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 11/15/2023

Event Type  malfunction  

Event Description

It was reported that a revision surgery was performed due to an anthem locking screw found to be backing out of an anthem distal femur plate post operatively.

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The device is not available for evaluation as it remains in the patient.The anthem distal femur plate and anthem large fragment screws were originally implanted on (b)(6) 2023.Due to back out of nine anthem large fragment screws from the polyaxial holes, one screw was explanted on (b)(6) 2023.The plate still remains implanted in the patient.The explanted screw has not been returned for evaluation.No definitive cause can be established explaining the exact reason for locking screw back-out.It is known that the surgeon did not use the torque limiting t-handle that is required for final tightening of the locking screws.However, it cannot be stated that this risk factor is the cause of locking screw back-out.No determinations could be made as to the cause of the reported issue.

• Brand Name: ANTHEM
• Type of Device: ANTHEM TI LATERAL NARROW DISTAL FEMUR PLATE, LEFT, 11 HOLE, 267MM
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 18810668
• MDR Text Key: 336861457
• Report Number: 3004142400-2023-00199
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1195.1211
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Race: White