ATTUNE 1506-11-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295416326), received between Nov 12, 2020 and Feb 2, 2024 — classified as 3 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 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.

• InjuryFeb 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18629182 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY TKR ON (B)(6) 2021 WHERE AN ATTUNE UNCEMENTED TIBIAL COMPONENT AND AN ATTUNE UNCEMENTED FEMORAL COMPONENT WAS UTILISED. SURGEON MENTIONED THAT HE WAS REQUIRED TO UNDERTAKE MANIPULATION UNDER ANAESTHESIA (MUA). PATIENT CONSEQUENCE DESCRIPTION/ A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT: LIMITED ROM, STIFFNESS.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 11884078 ↗
• InjuryNov 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY IN THE KNEE. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10831366 ↗