Arthrex® AR-513-BE08Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867107236), received between Aug 5, 2016 and Aug 5, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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 16, 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.

• InjuryAug 5, 2016Break

  IT WAS REPORTED THAT ON (B)(6) 2015, PATIENT UNDERWENT A LEFT TKA PROCEDURE. ON (B)(6) 2016 SURGEON PERFORMED A REVISION LEFT TKA DUE TO PATIENT PAIN. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR-503-TTTE (LOT 1297366 )(CC92723-LINE 166377), AND BEARING IMPLANT AR-513-BE08 (LOT 113601337A)(CC92723-LINE 166378). TO COMPLETE THE PROCEDURE THE SURGEON IMPLANTED THE FOLLOWING ARTHREX PARTS: TIBIAL TRAY AR-513-T4 (LOT 10038080), BEARING IMPLANT AR-513-BE13 (LOT 113601414) AND STEM EXTENSION IMPLANT AR-513-1450 (LOT 10036355). PATIENT WAS A FEMALE, (B)(6). DURING THE REVISION PROCEDURE WHEN THE AR-613-1 UNIVERSAL HANDLE LOT 1391544 (CC92723-LINE 166654) WAS BEING USED FOR THE REMOVAL OF THE TIBIAL PUNCH HEAD,. THE PUNCH HEAD WAS ABLE TO BE REMOVED BUT THE HANDLE BROKE IN THE PROCESS WHICH DID NOT RESULT IN PATIENT HARM. HANDLE IS BEING RETURNED FOR EVALUATION. PATIENT MEDICAL RECORDS OF (B)(6) 2016 NOTED THAT PATIENT WAS REPORTING CONTINUED KNEE PAIN AND SWELLING. PATIENT WAS INJECTED AND ASPIRATED AT THAT TIME. ON (B)(6) 2016 RECORDS NOTED THAT INJECTION/ASPIRATION HELPED WITH SYMPTOMS FOR ONLY A FEW DAYS. EXAMINATION OF THE LEFT KNEE DEMONSTRATED SWELLING. PAL

  Patient problems: Pain

  MAUDE report 5851599 ↗