Arthrex® AR-1355Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867013865), received between Apr 10, 2019 and Apr 10, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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.

• InjuryApr 10, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ACL RECONSTRUCTION PROCEDURE ON 3/15/2019 WHERE THE FOLLOWING DEVICES WERE IMPLANTED: AR-1349M/LOT: 10253224/QTY: 1; AR-1355/LOT: 10249019/QTY: 1; AR-7500/LOT: 100038/QTY: 1. AFTER THE SURGERY, INFECTION OF RESIDENT BACTERIA WAS OBSERVED AROUND THE POST SCREW ON THE TIBIAL SIDE. WHETHER THE STERILIZATION AND PROCEDURES OF INSTRUMENTS USED FOR SURGERY WERE APPROPRIATE IS CURRENTLY UNDER INVESTIGATION BY THE FACILITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION PROVIDED 4/2/2019: THREE DAYS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED OVER 40°C FEVER AND REDNESS, MILD SWELLING OF LOWER RIGHT THIGH PROXIMAL PART, AND FEELING OF HEAT. 5 DAYS AFTER, BLOOD WAS TAKEN AND INFLAMMATORY RESPONSE WAS HIGH.

  Patient problems: Burning Sensation; Erythema; Fever; Inflammation; Swelling; Unspecified Infection

  MAUDE report 8500756 ↗
• InjuryApr 10, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2019 WHERE THE FOLLOWING DEVICES WERE IMPLANTED: AR-1349M / LOT: 10217761 / QTY: 1, AR-1355 / LOT: 10237190 / QTY: 1, AR-7500 / LOT: S20197 / QTY: 2. AFTER THE SURGERY, INFECTION OF RESIDENT BACTERIA WAS OBSERVED AROUND THE POST SCREW ON THE TIBIAL SIDE. WHETHER THE STERILIZATION AND PROCEDURES OF INSTRUMENTS USED FOR SURGERY WERE APPROPRIATE IS CURRENTLY UNDER INVESTIGATION BY THE FACILITY. *ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION PROVIDED (B)(6) 2019: FOUR DAYS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED MILD SWELLING OF LOWER RIGHT THIGH PROXIMAL PART. 8 DAYS AFTER, THE PATIENT EXPERIENCED 38°C DEGREE FEVER AND REDNESS. 10 DAYS AFTER, BLOOD WAS TAKEN AND INFLAMMATORY RESPONSE WAS HIGH.

  Patient problems: Fever; Inflammation; Post Operative Wound Infection; Swelling

  MAUDE report 8500713 ↗