Arthrex® AR-523-B314Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867232402), received between Oct 21, 2019 and Oct 21, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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.

• InjuryOct 21, 2019Loose or Intermittent Connection; Unstable Capture Threshold

  IT WAS REPORTED THAT A PATIENT HAD A TOTAL KNEE PROCEDURE ON (B)(6) 2018. ROUGHLY ONE AND A HALF YEARS AFTER IMPLANTATION THE AR-523-B314 (LOT: 115571546) TIBIAL BEARING CAME LOOSE FROM THE TIBIAL TRAY, AND THE KNEE BECAME UNSTABLE. THE FOLLOWING ARTHREX PARTS WERE USED DURING THE PRIMARY PROCEDURE: AR-523-B314 // LOT: 115571546 // QTY.: 1. AR-524-PSC9 // LOT: 132581730 // QTY.: 1. AR-513-T3 // LOT: 10167303 // QTY.: 1. AR-516-5R // LOT: 10183110 // QTY.: 1. A BEARING EXCHANGE PROCEDURE TOOK PLACE ON (B)(6) 2019. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE AR-523-B314 (LOT: 115571546), AND IMPLANTED AR-513-BD18 (LOT: 113601819). THE REP REPORTED THE POLY WAS THE ONLY ARTHREX DEVICE EXPLANTED DURING THE REVISION PROCEDURE. THE PRIMARY RIGHT TKA AND THE BEARING EXCHANGE PROCEDURE WERE PERFORMED BY THE SAME SURGEON. THE EXPLANTED DEVICE HAS BEEN RETURNED TO ARTHREX.

  Patient problems: Failure of Implant

  MAUDE report 9214786 ↗