Arthrex® AR-513-BE14Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867107298), received between Dec 2, 2016 and Dec 2, 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 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.

• InjuryDec 2, 2016Device Operates Differently Than Expected

  IT WAS REPORTED THAT ON (B)(6) 2014 A PATIENT UNDERWENT A LEFT TKA PROCEDURE (DURING WHICH TIME THE PATELLA WAS NOT RESURFACED). ON (B)(6) 2015 THE PATIENT UNDERWENT A LEFT BEARING EXCHANGE/PATELLOPLASTY PROCEDURE ((B)(4)). ON (B)(6) 2016 THE SURGEON PERFORMED A LEFT TKA REVISION DUE TO TIBIAL LOOSENING AND PATIENT PAIN. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE FOLLOWING COMPONENTS: TIBIAL TRAY (B)(4), LOT 108761203 ((B)(4)), FEMORAL IMPLANT AR-503-PSLF, LOT 108761213 ((B)(4)), BEARING IMPLANT AR-513-BE14, LOT 113601330A ((B)(4)) AND PATELLA IMPLANT AR-504-PSD0, LOT 113601415 ((B)(4)). TO COMPLETE THE PROCEDURE THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT. PATIENT WAS A MALE, DOB (B)(6) 1956. PATIENT MEDICAL RECORDS DATE (B)(6) 2016 NOTED: FINDINGS LEFT KNEE X-RAY SHOWED PROSTHESIS IN PLACE, IN PROPER ANATOMICAL ALIGNMENT, WITHOUT ROTATION, LOOSENING OR STRESS SHIELDING. PATIENT MEDICAL RECORDS DATED (B)(6) 2016 NOTED: EXAMINATION OF THE LEFT KNEE DEMONSTRATES MEDIAL JOINT LINE TENDERNESS AND LATERAL JOINT LINE TENDERNESS. MILD EFFUSION OF THE LEFT KNEE WAS NOTED. PATIENT WAS UNSTABLE TO VALGUS STRESS AT 30 DEGREES FLEXION. RECORDS NOTED SURGEON RECOMMENDED A TOTA

  Patient problems: Increased Sensitivity; Pain; Swelling

  MAUDE report 6142643 ↗