MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. ANTHEM; ANTHEM TI LATERAL NARROW DISTAL FEMUR PLATE, LEFT, 9 HOLE, 234MM

Model Number	1195.1209
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/30/2025
Type of Reportable Event	Serious Injury
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.
Additional Manufacturer Narrative
The device was not available for evaluation.No determination could be made as to the cause of the reported issue.
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.
Additional Manufacturer Narrative
An anthem ti lateral narrow distal femur plate, left, 9 hole, 234mm (1195.1209) had locking screws back out in the distal end of the plate post-operatively requiring revision surgery.The plate was implanted on (b)(6) 2025 and the revision surgery to remove the plate and screws occurred on (b)(6) 2025.It was confirmed that the 7nm torque-limiting t-handle 6206.2707 was used to final tighten the screws.X-rays show that the patient had a total knee replacement.The x-rays provided show that none of the screws were colliding with or touching the knee replacement.The patient also presented as obese with hypertension and had a previous gastric bypass surgery.This could have potentially affected the plate/screw interface failure as bone mineral density tends to decline following gastric bypass surgery, hypertension tends to slow down the bone healing process, and obesity puts additional stress on the implants and fracture.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 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.The following sections were updated for this supplemental report: a1, b4, e1, e2, e3, g3, g6, h3, h6, h10.

• Brand Name: ANTHEM
• Common Device Name: ANTHEM TI LATERAL NARROW DISTAL FEMUR PLATE, LEFT, 9 HOLE, 234MM
• 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: 23174605
• Report Number: 3004142400-2025-00237
• Device Sequence Number: 9639674
• Product Code: HRS
• UDI-Device Identifier: 00193982456139
• UDI-Public: 00193982456139
• 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,Followup
• Report Date (Section B): 10/20/2025

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: 1195.1209
• Device Lot Number: SXC232BD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 09/29/2025
• Supplement Report FDA Received Date: 10/20/2025
• 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: 64 YR
• Patient Sex: Female
• Patient Weight: 85 KG
• Patient Race: White