ATTUNE 1516-30-306Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295047513), received between Aug 11, 2020 and Apr 30, 2025 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21938204 ↗
• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD IRRIGATION AND DEBRIDEMENT WITH POLY EXCHANGE DUE TO INFECTION. IT WAS NOTED THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20822665 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF ATTUNE PRIMARY IMPLANTS. REVISION DUE TO PATIENT PAIN AND CYST FORMATION BEHIND THE FEMORAL IMPLANT. ORIGINAL SURGERY DATE UNKNOWN.

  Patient problems: Cyst(s); Pain

  MAUDE report 20279967 ↗
• InjuryAug 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2018 BY IMPLANTING THE FEMORAL COMPONENT, THE TIBIAL TRAY, THE TIBIAL INSERT FOR THE PATIENT¿S LEFT KNEE JOINT. AFTER THE SURGERY, THE PATIENT SPRAINED HER ANKLE JOINT ON (B)(6) 2020 (THIS EVENT WAS REPORTED AS (B)(4)). IT WAS REPORTED THAT THE PATIENT HAD CHEST PAIN ON (B)(6) 2019, AND SHE WAS ADVISED EXAM BY PRIMARY CARE DOCTOR. THEN, SHE UNDERWENT CAG UNDER HOSPITALIZATION ON (B)(6) 2020 AT (B)(6) HOSPITAL, AND SHE WAS ADMITTED INTO THE HOSPITAL FROM (B)(6) 2020. SHE HAS NO SYMPTOM NOW AND IS IN TREATMENT WITH MEDICATION.

  Patient problems: Chest Pain; No Code Available

  MAUDE report 10393288 ↗