Arthrex® AR-513-BF18Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867107410), received between Jun 7, 2018 and Dec 7, 2020 — classified as 2 injuries.

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

• InjuryDec 7, 2020Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE A PATIENT HAD UNDERGONE A TKA PROCEDURE (B)(6) 2019. DURING THE 2019 PROCEDURE THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED: AR-513-T5, IBALANCE TKA MODULAR TIBIAL TRAY (LOT 10280798), AR-513-BF18, IBALANCE TKA BEARING IMPLANT (LOT 113601824), AR-516-6L, IBALANCE FEMORAL IMPLANT (LOT 10221540), AR-524-PSD0, PATELLA IMPLANT DOME (LOT 132581832). ROUGHLY 6 MONTHS POST OP PATIENT BEGAN HAVING ISSUES WITH FULLY EXTENDING THE KNEE. IT WAS REPORTED THERE WAS A POST-OP DISENGAGEMENT OF THE POLY FROM THE TRAY. THE PATIENT UNDERWENT A REVISION SURGERY AT THE SAME FACILITY BY THE SAME SURGEON. DURING THE REVISION ALL OF THE ORIGINAL ARTHREX DEVICES WERE EXPLANTED. TO COMPLETE THE REVISION PROCEDURE ANOTHER MANUFACTURER'S PRODUCT WAS USED. RISK MANAGEMENT DEPARTMENT AT THE FACILITY HAS POSSESSION OF THE EXPLANTED DEVICES. ADDITIONAL INFORMATION PROVIDED 11/23/2020: THE REVISION PROCEDURE TOOK PLACE (B)(6) 2020.

  Patient problems: Loss of Range of Motion

  MAUDE report 10962319 ↗
• InjuryJun 7, 2018Unstable

  IT WAS REPORTED THAT ON (B)(6) 2015 THE PATIENT UNDERWENT A LEFT TKA PROCEDURE. ON (B)(6) 2016 THE SURGEON PERFORMED A REVISION LEFT TKA PROCEDURE DUE TO PATIENT PAIN ((B)(4)/MFR REPORT # 1220246-2016-00295). ON (B)(6) 2017, A DIFFERENT SURGEON PERFORMED A SECOND REVISION DUE TO INSTABILITY. DURING THIS REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR-513-T5 (LOT 1003440), FEMORAL IMPLANT AR-516-5L (LOT 1482387), BEARING IMPLANT AR-513-BF-18 (LOT 113601335) AND PATELLA IMPLANT AR-504-PSC9 (LOT 113601511). THE REVISION WAS COMPLETED USING ANOTHER MANUFACTURERS PRODUCT. PATIENT FEMALE, (B)(6).

  Patient problems: Failure of Implant; No Code Available; Pain

  MAUDE report 7580279 ↗