Arthrex® AR-13402-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867012134), received between Dec 2, 2020 and Dec 2, 2020 — classified as 1 injury.

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, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A (B)(6) 2019 RIGHT KNEE TIBIAL OSTEOTOMY. APPROXIMATELY 3 MONTHS AFTER SURGERY PATIENT WAS ALL HEALED BUT HAD DEVELOPED SOME PAIN FROM PHYSICAL THERAPY ON TOP OF HIS KNEE FROM OVERUSE. SURGEON PRESCRIBED TOPICAL OINTMENT. PATIENT WAS ALLERGIC TO THE OINTMENT AND HIS KNEE SWELLED UP AND WAS ITCHY. PATIENT DEVELOPED A STAFF INFECTION FROM THE OUTSIDE UNDER THE SKIN. A CLEANOUT SURGERY PERFORMED (B)(6) 2019. EVERYTHING WAS FINE FROM THERE. PATIENT HAD TO TAKE ANTIBIOTICS APPROXIMATELY 4 MONTHS INTRAVENOUSLY TO PREVENT INFECTIONS. NO INFECTIONS EVER OCCURRED. APPROXIMATELY 6 MONTHS POST (B)(6) 2019 TIBIAL OSTEOTOMY PATIENT BEGAN HAVING SYMPTOMS THAT HAVE PROGRESSIVELY BECOME WORSE. SYMPTOMS ARE AS FOLLOWS: TINNITUS: STARTED A FEW MONTH POST (B)(6) 2019 SURGERY AND IS NOW AT A LEVEL OF BEING UNBEARABLE. PATIENT ACTUALLY RUNS LEAF BLOWER OUTSIDE TO HELP DROWN OUT THE TINNITUS NOISE BECAUSE HE CANNOT TAKE IT. THIS HAS BEEN ONGOING AND HAS NEVER STOPPED. IT ONLY CONTINUES TO WORSEN. GOUT LIKE SYMPTOMS: PATIENT HAS HAD SEVERAL ATTACKS. IN THE BEGINNING IT WAS THOUGHT PATIENT WAS HAVING A HEART ATTACK. HIS HEART WAS RACING AND THEN MYSTERIOUSLY WOU

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Cognitive Changes; Confusion/ Disorientation; Decreased Appetite; Diarrhea; Fatigue; Headache; Hypersensitivity/Allergic reaction; Itching Sensation; Memory Loss/Impairment; Pain; Rash; Sleep Dysfunction; Tinnitus

  MAUDE report 10934359 ↗