MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. ANTHEM; ANTHEM TI LATERAL NARROW DISTAL FEMUR PLATE, RIGHT, 15 HOLE, 331MM

Model Number	1195.2215
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An anthem ti lateral narrow distal femur plate, right, 15 hole, 331mm (1195.2215) had locking screws back out in the distal end of the plate post-operatively requiring revision surgery.The plate was implanted in (b)(6)2024 and the revision surgery to remove the plate and screws occurred in (b)(6) 2025.It was confirmed that the 7nm torque-limiting t-handle 6206.2707 was used to final tighten the screws.Imaging of the plate showed deformation of the plate polyaxial sweeps consistent with what would be expected following locking screw placement.Thread cutout in the top surface of the plate screw holes indicate that some of the screws were inserted at an angle.It is unclear whether the screws were inserted past their maximum recommended angulation.Measurement of the unused screw holes in the plate were within dimensional specifications.This is the fifth complaint for screw back out in a distal femur plate.All complaints occurred in a ti plate.Unfortunately, no definitive cause can be established for the screw back out.This evaluation determined that this failure exceeds expected risk, the patient had multiple contraindications for receiving an anthem distal femur plate; therefore, no further actions will be taken at this time.
Event or Problem Description
It was reported that there was a revision due to anthem screws backing out of the plate and some of the screw heads shearing off.

• Brand Name: ANTHEM
• Common Device Name: ANTHEM TI LATERAL NARROW DISTAL FEMUR PLATE, RIGHT, 15 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: 23360679
• Report Number: 3004142400-2025-00239
• Device Sequence Number: 15658023
• Product Code: HRS
• UDI-Device Identifier: 00193982456276
• UDI-Public: 00193982456276
• 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: 2024
• 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): 10/22/2025

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: 1195.2215
• Device Lot Number: SXB069CD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 44 YR
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Race: White