Arthrex® AR-523-B410Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867232464), received between Dec 28, 2020 and Mar 11, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED ON 09/19/2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-523-B410 TIBIAL BEARING WOULD NOT FIT INTO THE IMPLANT. "OVER HANG OF ADDITIONAL MATERIAL NOT ALLOWING IT TO SNAP INTO THE TIBIAL TRAY". A NEW TRAY WAS POLY WAS USED AND CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18876356 ↗
• InjuryDec 28, 2020Unstable; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  IT HAS BEEN REPORTED THAT A PATIENT WHO HAD A TKA PROCEDURE (DATE PENDING) PRESENTED IN THE SURGEON'S CLINIC ON (B)(6) 2020 WITH COMPLAINTS OF HER KNEE FEELING UNSTABLE. FOLLOW UP EVALUATION AND X-RAYS WERE COMPLETED AND REPORTER STATES IT WAS EVIDENT THAT THE TIBIAL BEARING IMPLANT AR-523-B410 (LOT 115571546) HAD DISASSOCIATED ANTERIORLY. PATIENT DID REPORT HAVING A FALL INCIDENT REPORTED APPROXIMATELY (B)(6) 2020. AT THAT TIME KNEE JOINT WAS EVALUATED AND ASSESSED AS STABLE. REVISION PROCEDURE TOOK PLACE (B)(6) 2020. FULL DETAILS ON ALL EXPLANTED PARTS IS PENDING. ADDITIONAL INFORMATION OBTAINED 12/15/20: THE ORIGINAL TKA PROCEDURE WAS (B)(6) 2020. THE ONLY ORIGINAL IMPLANT THAT WAS EXPLANTED IS THE TIBIAL BEARING. AR-523-B410. THE BEARING WAS REPLACED AND ALL OTHER TKA COMPONENTS WERE LEFT IN THE PATIENT.

  Patient problems: Fall

  MAUDE report 11075937 ↗