ATTUNE 1516-30-414Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295047681), received between May 26, 2021 and May 12, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Unintended Movement” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS INFECTED AND CHANGED OUT POLY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 16918211 ↗
• InjuryNov 4, 2022Unintended Movement; Unintended Movement

  REVISION OF TKR FOR BEARING SPIN OUT + FEMORAL ROTATION FROM ORIGINAL PRIMARY . PATIENT'S ORIGINAL PRIMARY SURGERY WAS DONE ON THE (B)(6) 2022 AND SHE HAD A POLY EXCHANGE ON THE (B)(6) 2022 AND THEN HAD ANOTHER REVISION FOR BEARING SPIN OUT AND THE POLY AND THE FEMUR WERE CHANGED. ALL PROCEDURES DONE AT CALVARY ADELAIDE BY PROF FOR LEFT KNEE. DOI: (B)(6) 2022. DOR: (B)(6) 2022. LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15726831 ↗
• InjuryMay 26, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT'S POLY SPUN OUT DUE TO ATTENUATION OF MCL AFTER INITIAL TKA. DOI: UNKNOWN DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11891713 ↗