Arthrex® AR-513-T4Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867187870), received between Oct 24, 2018 and Jan 10, 2025 — classified as 2 injuries.

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 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.

• InjuryJan 10, 2025Break; Break

  ON (B)(6) 2024, A PATIENT-REPORTED VIA PHONE THAT ON (B)(6) 2024, UNDERWENT REVISION SURGERY TO HAVE AN AR-513-T4 IBALANCE TKA TIBIAL TRAY REMOVED. THE INITIAL SURGERY OCCURRED ON (B)(6) 2022; THE PATIENT WAS UNSURE. IT WAS THEN DISCOVERED, ABOUT TWO YEARS LATER, IN LATE OR EARLY OF (B)(6) 2024, VIA X-RAY, THAT THE PLATE HAD FRACTURED. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2024 TO HAVE THE PLATE REMOVED. THE CASE WAS COMPLETED USING NEW IMPLANTS FROM ANOTHER MANUFACTURER.

  Patient problems: Failure of Implant

  MAUDE report 21128835 ↗
• InjuryOct 24, 2018Device Slipped

  IT WAS REPORTED VIA PATIENT LEGAL REPRESENTATIVE THAT ON (B)(6) 2016 THE PATIENT HAD UNDERGONE A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE. THE PATIENT WAS LATER DIAGNOSED WITH FAILED RIGHT TOTAL KNEE ARTHROPLASTY SECONDARY TO LOOSENING AND THE PATIENT UNDERWENT A REVISION RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2018 AT A DIFFERENT FACILITY BY A DIFFERENT SURGEON. ALTHOUGH THE DIAGNOSIS MENTIONED LOOSENING, THERE WAS NO MENTION IN THE REVISION OP REPORT NOTING THAT ANY LOOSENING WAS FOUND. THE PATIENT'S MEDICAL RECORDS ALSO NOTE THAT THE PATIENT IS MORBIDLY OBESE (BMI 42+ PRE AND POST SURGERY) WHICH IS CONTRAINDICATED FOR THIS DEVICE. DURING THE REVISION PROCEDURE THE FOLLOWING ARTHREX IMPLANTS WERE REMOVED: AR-513-T4 TIBIAL TRAY (LOT 10057043), AR-516-6R FEMORAL IMPLANT (LOT 1578051), AR-5623-B410 BEARING IMPLANT (LOT 115571546) AND AR-504-PSC9 PATELLA IMPLANT (LOT 132581609). THE REVISION PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER'S PRODUCTS.

  Patient problems: No Code Available

  MAUDE report 8001597 ↗