Arthrex® AR-513-BE09Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867107243), received between Apr 10, 2017 and May 22, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2017Loose or Intermittent Connection

  IT WAS REPORTED THAT ON (B)(6) 2015 A PATIENT HAD UNDERGONE A TKA PROCEDURE DURING WHICH THE PATELLA WAS NOT RESURFACED. ON (B)(6) 2017 THE SURGEON PERFORMED A REVISION TKA DUE TO TIBIAL LOOSENING AND PAIN. DURING THE REVISION THE FOLLOWING DEVICES WERE EXPLANTED: TIBIAL TRAY, AR-503-TTTE, LOT 1315462, FEMORAL IMPLANT, AR-516-5R, LOT 108761425 AND BEARING IMPLANT, AR-513-BE09, LOT 113601402. THE REVISION WAS COMPLETED USING ANOTHER MANUFACTURER'S PRODUCT. THE OPERATIVE REPORTS AND MEDICAL RECORDS INDICATE PATIENT IS MORBIDLY OBESE (BMI OF 37.94) WHICH IS CONTRAINDICATED FOR THIS PRODUCT.

  Patient problems: Pain

  MAUDE report 6581001 ↗
• InjuryApr 10, 2017Loose or Intermittent Connection

  IT WAS REPORTED THAT ON (B)(6) 2015 PATIENT UNDERWENT BILATERAL TKA PROCEDURE. PATIENT HAD A REVISION LEFT TKA ON (B)(6) 2017 DUE TO TIBIAL LOOSENING AND PAIN. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR-503-TTTE (LOT 1297366), AND BEARING IMPLANT AR-513-BE09 (LOT 113601338A). TO COMPLETE THE PROCEDURE THE SURGEON IMPLANTED THE FOLLOWING ARTHREX PRODUCTS: TIBIAL TRAY, AR-513-T4 (LOT 10060962) AND BEARING IMPLANT, AR-513-BE16 (LOT 113601340). THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED FROM PATIENT MEDICAL RECORDS: RECORDS DATED (B)(6) 2016: PATIENT BIKES, KAYAKS AND DOES WATER AEROBICS AND THINKS SHE MAY HAVE OVERDONE IT. X-RAY FINDINGS LEFT KNEE: PROSTHESIS IN PLACE IN PROPER ANATOMICAL ALIGNMENT WITHOUT ROTATION, LOOSENING OR STRESS SHIELDING. RECORDS DATED (B)(6) 2017: PATIENT HAS BEEN HAVING INCREASED LEFT KNEE PAIN. ASPIRATION FLUID TWO MONTHS PRIOR WAS NEGATIVE FOR INFECTION. PATIENT REPORTED IT FELT LIKE A TIGHT BAND ACROSS HER KNEE WITH THROBBING AND BURNING PAIN IN THE ANTERIOR TIBIA. EXAMINATION OF THE LEFT KNEE DEMONSTRATED NO SWELLING OR ECCHYMOSIS. PALPATION OF THE LEFT KNEE DEMONSTRATED MEDICAL JOINT LINE AND MEDIAL TIBIAL PLATEAU TEND

  Patient problems: Discomfort; Pain

  MAUDE report 6476721 ↗