Arthrex® AR-513-T2Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867187856), received between Oct 7, 2025 and Oct 7, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Degraded” (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.

• InjuryOct 7, 2025Degraded; Patient Device Interaction Problem; Degraded; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 10/14/2025: PER THE PATIENT'S MEDICAL RECORDS, THE PATIENT REPORTED PERSISTENT PAIN RATED BETWEEN 7/10 AND 9/10, STIFFNESS, AND LIMITED RANGE OF MOTION FROM THE TIME OF IMPLANTATION. THE PATIENT WAS UNABLE TO RETURN TO THE PREVIOUS LEVEL OF ACTIVITY AND RELIED ON A CANE FOR MOBILITY. FREQUENT FALLS AND FUNCTIONAL DECLINE WERE NOTED, INCLUDING DIFFICULTY WITH DAILY TASKS SUCH AS SHOPPING AND EXERCISING. IMAGING AND CT SCANS PERFORMED IN 2024 SHOWED NO GROSS MALPOSITIONING, BUT MILD TIBIAL ROTATION WAS NOTED. DESPITE THESE FINDINGS, THE PATIENT CONTINUED TO EXPERIENCE DEBILITATING SYMPTOMS. A SURGICAL PATHOLOGY REPORT DATED (B)(6) 2025 CONFIRMED MECHANICAL LOOSENING OF THE IMPLANT AND DEGENERATIVE CHANGES IN THE SURROUNDING BONE AND SYNOVIAL TISSUE. PHYSICAL THERAPY RECORDS POST-REVISION DOCUMENTED IMPROVED GAIT, REDUCED SWELLING, AND PROGRESS TOWARD FUNCTIONAL GOALS, INCLUDING STAIR CLIMBING AND SIT-TO-STAND EXERCISES. PAIN LEVELS DECREASED TO AN AVERAGE OF 2¿5/10, WITH CONTINUED MONITORING AND REHABILITATION.

  Patient problems: Bone Fracture(s); Failure of Implant; Pain

  MAUDE report 23238005 ↗