Arthrex® AR-13401-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867012011), received between Sep 15, 2016 and Sep 15, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Malposition of Device” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2016Malposition of Device

  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 (B)(4). ON (B)(6) 2016 PATIENT UNDERWENT A REVISION PROCEDURE AND THE FOLLOWING FROM THE ORIGINAL PROCEDURE IMPLANTS WERE EXPLANTED: AR-13402-36 LOT 403105 ((B)(4) -LINE (B)(6)), AR-13402-34 LOT 403097((B)(4) -LINE (B)(6)), AR-13401-28 LOT 1188749 ((B)(4) -LINE (B)(6)) AND AR-13400M-12 LOT 1360929 ((B)(4) -LINE (B)(6)). 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 5953763 ↗