ANTHEM 1195.2215Recalls & reported problems
Globus Medical, Inc. · ANTHEM Ti Lateral Narrow Distal Femur Plate, Right, 15 Hole, 331mm · Class 2
All models of ANTHEM (27)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00193982456276), received between Oct 22, 2025 and Jun 15, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Material Integrity Problem1
- Patient Device Interaction Problem1
Patient problems
- Failure of Implant2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 15, 2026Fracture; Patient Device Interaction Problem
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.
Patient problems: Failure of Implant
MAUDE report 25506070 ↗InjuryOct 22, 2025Material Integrity Problem; Material Integrity Problem
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.
Patient problems: Failure of Implant
MAUDE report 23360679 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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