Arthrex® AR-513-BC16Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867107106), received between Nov 16, 2022 and Nov 16, 2022 — classified as 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 16, 2022Device Dislodged or Dislocated

  ON 10/28/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT A PATIENT UNDERWENT REVISION SURGERY DUE TO AN AR-513-BC16 TKA TIBIAL BEARING DISASSOCIATING FROM THE TIBIAL TRAY. NO FURTHER INFORMATION HAS BEEN GIVEN AT TIME. ADDITIONAL INFORMATION RECEIVED ON 11/3/2022: DUE TO OSTEOARTHRITIC KNEE, PATIENT HAD A TKA PROCEDURE ON (B)(6) 2018. AN AR-516-5L FEMORAL IMPLANT, AN AR-524-PSBB8 PATELLA IMPLANT DOME, AN AR-513-T2 TIBIAL TRAY, AN AR-523-B214 TIBIAL BEARING, AND AN AR-513-BC16 TIBIAL BEARING WERE IMPLANTED. WHEN THE TIBIAL BEARING AND THE TIBIAL TRAY DISASSOCIATED FROM ONE ANOTHER, A POLY EXCHANGE PROCEDURE WAS PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, AN AR-513-BC16 TIBIAL BEARING, LOT NUMBER 113601350, WAS REMOVED AND AN AR-513-BC16 TIBIAL BEARING, LOT NUMBER 113601816 WAS IMPLANTED. CASE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES. BOTH SURGERIES TOOK PLACE IN THE SAME FACILITY AND PERFORMED BY THE SAME SURGEON.

  Patient problems: Failure of Implant

  MAUDE report 15804010 ↗