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

Model Number	2187.4120
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	02/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The implantation occurred in (b)(6) 2025 as the patient suffered a periprosthetic fracture around a total knee replacement and the lateral proximal tibia plate was implanted.It was reported that the patient tried to weight bear a couple of weeks post-op and sustained an additional fracture on the medial side of the tibia.The patient was brought back in to add another plate medially, but it was noticed in the or after taking x-rays that the lateral proximal tibia plate was fractured through one of the compression slots in the plate.The plate was removed and replaced with large fragment plates on the lateral and medial side.It was reported that the patient had a high bmi and attempted repeated early weight-bearing after the initial plate implantation.The x-rays of the construct also show a long working length and a screw backing out.It is reported that the surgeon believes the implant was not sufficient for the patient due to the contraindications of a high bmi and early weight bearing which is likely to have stressed the implant prior to adequate healing and cause the plate failure.The plate was not returned for evaluation, therefore, the dhr and ncmr record could not be evaluated.Should the plate be returned, the investigation shall be reopened.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 this plate was put into a patient with a proximal tibia fracture in mid (b)(6) 2025.The patient attempted to put weight on his right leg too soon causing another fracture in his right tibia.He was brought back for additional surgery.The initial plan was to put another plate medially.However, once the surgeon took x-rays in the operating room, he noticed that the proximal tibia plate was broken.The proximal tibia plate was removed due to this.The surgeon stated that he does not believe the plate was necessarily the problem, he thinks the cause was the patient putting too much pressure on the implant too early on.The surgeon also stated that this plate was not sufficient for the patient due to his size and that could have been another cause.

• 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: 24545144
• Report Number: 3004142400-2026-00037
• Device Sequence Number: 15751570
• Product Code: HRS
• UDI-Device Identifier: 00889095614107
• UDI-Public: 00889095614107
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 03/09/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2187.4120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Male