Arthrex® AR-523-A714Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867231849), received between Jun 19, 2024 and Jun 19, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 18, 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.

• MalfunctionJun 19, 2024Break; Break

  ON 10/11/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-523-A714 CR PLUS TIB BEARING IMPLANT HAD AN ISSUE. DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE ON 10/6/2022, WHEN THE SURGEON WAS TRYING TO USE THE DEVICE, THE DEVICE FAILED TO ENGAGE IN THE TIBIAL TRAY, IT WOULD NOT LOCK, AND THE PERIPHERAL LOCKING MECHANISM WOULD NOT ENGAGE. THE SURGEON REMOVED THE COMPLAINT DEVICE FROM THE PATIENT, IT WAS REMOVED IN ONE PIECE AND NO PIECE OF THE INSTRUMENT BROKE INSIDE THE PATIENT. UPON INVESTIGATION, IT WAS STATED THAT THE PERIPHERAL POLY WAS BENT/DEFORMED. THE SURGEON USED ANOTHER AR-523-A714, LOT NUMBER UNKNOWN TO COMPLETE THE CASE SUCCESSFULLY WITH NO IMPACT TO THE PATIENT. THE COMPLAINT DEVICE WAS DISCARDED BY THE FACILITY. IT WAS STATED THAT THIS MIGHT HAVE HAPPENED AS AN OUT-OF-BOX EVENT, BUT IT COULD NOT BE VERIFIED AS NO PICTURES WERE TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567431 ↗