Arthrex® AR-523-B409Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867232457), received between Apr 22, 2024 and Apr 22, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fitting Problem” (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.

• MalfunctionApr 22, 2024Fitting Problem; Fitting Problem

  ON 9/29/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-523-B409 PS TIBIAL BEARING BACK SIDE WAS ROUND. SURGEON ATTEMPTED TO IMPACT THE POLY IN, WITHOUT ANY SUCCESS, AS THE SURGEON COULD EASILY LIFT IT OUT. THE POLY WOULD NOT SNAP IN. ANOTHER POLY WAS OPENED AND BOTH WERE EXAMINED PRIOR TO IMPLANTATION. THAT IS WHEN SURGEON NOTICED THE DIFFERENCE IN APPEARANCE. THE NEW POLY WAS USED TO COMPLETE THE CASE WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING A TOTAL KNEE PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED 10/3/2022: NOTHING BROKE INSIDE THE PATIENT AND CASE WAS COMPLETED WITH ANOTHER AR-523-B409 PS TIBIAL BEARING FROM LOT NUMBER 5791824.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154272 ↗