Arthrex® AR-13400M-12Recalls & reported problems
Arthrex, Inc. · HTO IMPL,IBAL SM 14°/MED 12° · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867011878), received between Sep 15, 2016 and Sep 15, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
- Unexpected Therapeutic Results1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2016Unexpected Therapeutic Results; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT PATIENT HAD UNDERGONE AN OSTEOTOMY PROCEDURE ON (B)(6) 2016 WHICH RESULTED IN A POOR OUTCOME OF HIS KNEE BEING OVER CORRECTED 4 DEGREES INWARD. THIS WAS REPORTED TO ARTHREX UNDER FILE CC94754. ON (B)(6) 2016 PATIENT UNDERWENT A REVISION PROCEDURE AND THE FOLLOWING FROM THE ORIGINAL PROCEDURE IMPLANTS WERE EXPLANTED: AR-13402-36 LOT 403105 (CC95348 -LINE 169680), AR-13402-34 LOT 403097(CC95348 -LINE 169682), AR-13401-28 LOT 1188749 (CC95348 -LINE 169683) AND AR-13400M-12 LOT 1360929 (CC95348 -LINE 169684). IT WAS REPORTED THAT THE INTRAOPERATIVE IMAGING FROM THE END OF THE FIRST SURGERY TO THE BEGINNING OF THE SECOND SURGERY MATCHED. SURGEON ACCOMPLISHED WHAT HE PLANNED FOR THE REVISION AND SURGEON CONCLUDED THAT THE PATIENT POOR OUTCOME WAS DUE TO A WEIGHT BEARING ISSUE THAT COULD NOT BE CAUGHT DURING THE ORIGINAL PROCEDURE.
Patient problems: No Code Available
MAUDE report 5953771 ↗
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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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