Arthrex® AR-523-B510Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867232570), received between Nov 16, 2020 and Nov 16, 2020 — classified as 1 injury.

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.

• InjuryNov 16, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A MEDICAL PROFESSIONAL THAT A PATIENT UNDERWENT A TOTAL KNEE PROCEDURE (B)(6) 2018. THE PATIENT LATER UNDERWENT A REVISION TKA PROCEDURE SOMETIME IN (B)(6) 2020. ADDITIONAL INFORMATION OBTAINED 10/27/2020: AN ARTHREX SALES REP HAS OBTAINED AND PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: . PATIENT HAD REPORTED TO A DIFFERENT SURGEON AS HAVING PAIN ON THE OPERATIVE SIDE. THE SECOND SURGEON PERFORMED A REVISION TKA, (B)(6) 2020 AND REVISED THE TIBIAL COMPONENT. THE FEMUR WAS FOUND TO BE WELL FIXATED AT THE TIME OF REVISION. THE FOLLOWING ORIGINAL IMPLANT DEVICES WERE EXPLANTED AT THE TIME OF REVISION: AR-513-T5, IBALANCE TKA TIBIAL TRAY, LOT 10183321. AR-523-B510 , IBALANCE TKA TIBIAL BEARING IMPLANT (SIZE 5), LOT 5791643. THE FOLLOWING ORIGINAL IMPLANT DEVICES WERE LEFT IN THE PATIENT AT THE TIME OF REVISION: AR-516-6L, IBALANCE TKA FEMORAL IMPLANT, LOT 10053281. AR-524-PSC9, IBALANCE PATELLA IMPLANT, LOT 132581743. THE FOLLOWING DEVICES WERE IMPLANTED AT THE TIME OF REVISION: AR-513-T4, IBALANCE TKA MODULAR TIBIAL TRAY, LOT 10572760. AR-513-BE-16, IBALANCE TKA BEARING IMPLANT (SIZE 4), LOT 113601819. AR-513-1050. IBALANCE TKA TIBIAL STEM, LOT 10018103.

  Patient problems: Pain

  MAUDE report 10842947 ↗