Arthrex® AR-513-BG10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867107458), received between Dec 9, 2016 and Dec 9, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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.

• InjuryDec 9, 2016Device Operates Differently Than Expected

  IT WAS REPORTED THAT ON (B)(6) 2015 THE PATIENT UNDERWENT A LEFT TKA PROCEDURE DURING WHICH ARTHREX IBALANCE TKA DEVICES WERE IMPLANTED. ON (B)(6) 2015, WHILE AT PHYSICAL THERAPY, THE PATIENT'S THERAPIST NOTICED THAT THE KNEE WAS NOT CORRECTING. ON (B)(6) 2015, THE PATIENT WENT TO SEE THE ORIGINAL SURGEON WHO RECOMMENDED EITHER A LATERAL RELEASE OR A TOTAL REVISION SURGERY TO CORRECT THE KNEE. ON (B)(6) 2016 PATIENT WAS SEEN BY A NEW SURGEON FOR A SECOND OPINION AND A LEFT TKA REVISION SURGERY WAS PERFORMED ON (B)(6) 2016 BY THE NEW SURGEON AT A DIFFERENT FACILITY THAN THE ORIGINAL SURGERY FACILITY. PATIENT REPORTS THAT THE FOLLOWING ARTHREX DEVICES WERE EXPLANTED DURING THE REVISION SURGERY: AR-503-TTTF, IBALANCE SIZE 5 TIBIAL TRAY, LOT: 108761211 ((B)(4) (B)(6)), AR-516-5L, FEMORAL IMPLANT, LOT 1373716 ((B)(4) (B)(6)) AND AR-513-BG10, BEARING IMPLANT, LOT 113601341 ((B)(4) (B)(6)). THE ORIGINAL ARTHREX PATELLA IMPLANT WAS LEFT IN THE PATIENT AND ANOTHER MANUFACTURER'S PRODUCT WAS USED TO COMPLETE THE TKA REVISION. THE PATIENT REQUESTED AND HAS KEPT THE EXPLANTED ARTHREX DEVICES.

  Patient problems: No Code Available

  MAUDE report 6157544 ↗