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

Model Number	1195.2215
Medical Device Problem Codes	Fracture (1260); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that at the patient's last follow-up in (b)(6) 2026, imaging showed that the plate broke and there is am atrophic non-union.The surgeon removed the plate and screws on (b)(6) 2026.All screws were removed from the patient and none of the screws were broken.
Additional Manufacturer Narrative
An anthem titanium lateral narrow distal femur plate, 1195.2215, 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) 2026.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.Upon receiving the complaint, the dhr and ncmr record for the lot number provided were reviewed.No ncmr's exist for this lot.All parts passed aql inspection with no rejections, and the entire lot was accepted on 22 jan 2024.The material certifications meet specifications.It was reported that the patient was diagnosed with breast cancer and was treated with two rounds of chemotherapy following the original surgery.The patient also has hypertension andhypothyroidism.The previously stated patient factors may influence bone healing.Follow up x-rays taken at approximately 6 weeks and 6 months post-operatively show lack of bone healing of the original fracture.At the time of plate failure, the patient presented with an atrophic non-union distal femur fracture.The plate breakage occurred with the incident of the patient crashing a golf cart into a garage with the leg sticking out.This evaluation determined that this failure was within expected risk and occurrence; therefore, no further actions will be taken at this time.

• 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: 25506070
• Report Number: 3004142400-2026-00119
• Device Sequence Number: 21459272
• 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: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2026

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: SXB317FD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White