ATTUNE 1523-05-202Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295057628), received between Jul 19, 2021 and Aug 12, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Migration” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Bone Notching

  MAUDE report 50226296 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS A KNOWN STAPH EPI INFECTION. ALL COMPONENTS WERE REMOVED. THERE WAS NO SURGICAL DELAYS. THERE WAS NO PATIENT CONSEQUENCES. NO PARTS WERE BROKEN. LOT NUMBERS WERE NOT VISIBLE. DOI: UNKNOWN. DOR:(B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19764793 ↗
• InjuryMay 20, 2024Migration; Migration

  IT WAS REPORTED THAT THIS PATIENT'S KNEE WAS REVISED DUE TO SUBSIDENCE OF HER ATTUNE REVISION TIBIAL BASE COMPONENTS. DURING THIS PROCEDURE, TIBIAL INSERT AND TIBIAL BASE COMPONENTS WERE REMOVED. THEY WERE THEN REPLACED BY NEW ATTUNE REVISION COMPONENTS, TO INCLUDE AN ATTUNE REVISION CONE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19350500 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT'S PREVIOUSLY REVISED KNEE WAS REVISED A SECOND TIME DUE TO PAIN AND INSTABILITY. THE PATIENT'S ATTUNE REVISION KNEE COMPONENTS WERE REMOVED AND REPLACED BY AN S-ROM NOILES HINGED FEMUR, AN LPS HINGED RP INSERT, AND A SIGMA REVISION MBT TIBIAL TRAY. DEPUY SMARTSET MEDIUM VISCOSITY BONE CEMENT WOULD HAVE BEEN USED IN THE PRIOR REVISION PROCEDURE, SINCE THE HOSPITAL ONLY STOCKS SMARTSET CEMENT. THE PRODUCT CODES AND LOT NUMBERS FOR THE CEMENT IS NOT AVAILABLE, SINCE THE CEMENT USED WAS HOSPITAL INVENTORY ORDERED DIRECTLY FROM DEPUY.DOI: (B)(6) 2020. DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 13170677 ↗
• InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS STATED THAT "PAIN WITH LEVEL WALKING IS 8''.

  Patient problems: Fatigue; Joint Laxity; Pain

  MAUDE report 12189547 ↗