MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. ANTHEM; INTERNAL ORTHOPAEDIC FIXATION SYSTEM, PLATE/SCREW, NON-BIOABSORBABLE, NON-STERIL

Model Number	2195.1015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An anthem stainless steel lateral narrow distal femur plate was broken post-operatively about 10 months after implantation and required surgery to remove it.The implantation occurred on (b)(6) 2025, and the date of removal was (b)(6) 2025.The plate broke at the location of the kickstand screws in the plate and it was reported that the patient presented with a non-union.It was reported that the patient experienced a car crash which likely caused excessive forces to go through the plate and cause the breakage.The x-ray images attached to this complaint evaluation show the non-union that this patient was experiencing.The plate breakage occurred with the incident of a motor vehicle collision.Although the surgeon was following up with the progression of healing following the primary surgery, there was no plan to revise the fixation prior to the motor vehicle collision.This evaluation determined that this failure was within expected risk and occurrence; therefore, no further actions will be taken at this time.
Event or Problem Description
It was reported that the patient had original surgery for a left distal femur fracture (b)(6) 2025.The plate broke around where the kickstand screws are inserted and patient presented with a non-union.This was identified at a post-op follow-up.

• Brand Name: ANTHEM
• Common Device Name: INTERNAL ORTHOPAEDIC FIXATION SYSTEM, PLATE/SCREW, NON-BIOABSORBABLE, NON-STERIL
• 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: 23632724
• Report Number: 3004142400-2025-00277
• Device Sequence Number: 9317892
• Product Code: HRS
• UDI-Device Identifier: 00193982017125
• UDI-Public: 00193982017125
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K213591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 2195.1015
• Device Lot Number: SXB095AD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2023
• 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 Sex: Unknown