MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. ANTHEM DISTAL FEMORAL FRACTURE SYSTEM; ANTHEM TI LATERAL BROAD DISTAL FEMUR PLATE, RIGHT, 23 HOLE, 331MM

Model Number	1195.4223
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was returned for evaluation.Initial observation of the plate indicates that the plate fracture was likely a result of fatigue failure.Microscopic imaging of the beachmarks, beachmarks which are marks indicative of fatigue failure, were visible originating from the top surface of the plate at the hole location where the plate fractured.It is known that the patient was obese, which is a contraindication for the anthem distal femur plates.This risk fracture may have contributed to the plate fracture; however, an exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported that there was a revision surgery to replace an anthem ti lateral broad distal femur plate that was found broken post operatively.

• Brand Name: ANTHEM DISTAL FEMORAL FRACTURE SYSTEM
• Common Device Name: ANTHEM TI LATERAL BROAD DISTAL FEMUR PLATE, RIGHT, 23 HOLE, 331MM
• 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: 18834284
• Report Number: 3004142400-2023-00080
• Device Sequence Number: 15313181
• Product Code: HRS
• UDI-Device Identifier: 00193982456498
• UDI-Public: 00193982456498
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K213591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1195.4223
• Device Lot Number: SXA018ED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Race: White