ATTUNE 1549-08-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295383147), received between Jun 29, 2020 and Oct 27, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL CONSTRUCT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT ONE STAGE REVISION DONE DUE TO INFECTION. DOI: UNKNOWN DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23390335 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL CONSTRUCT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT ONE STAGE REVISION DONE DUE TO INFECTION. DOI: UNKNOWN DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23390128 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO DISTAL FEMORAL FRACTURE. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Limb Fracture

  MAUDE report 22967294 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO DISTAL FEMORAL FRACTURE. DOI: (B)(6) 2021 DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Limb Fracture

  MAUDE report 22967070 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD INFECTION IN KNEE AND WAS REVISED DUE TO THAT. THE SURGEON REMOVED ALL COMPONENTS AND PLACED ABX SPACER. NO SURGICAL DELAY. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22025694 ↗
• MalfunctionApr 26, 2023Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT THE 12 MM POSTERIOR AUGMENT FOR ATTUNE REVISION WOULD NOT THREAD INTO FEMUR, THREADS FELT STRIPPED ACCORDING TO SURGEON AND THE AUGMENT WOULD NOT FULLY SEAT ON SZ 8 FEMORAL COMPONENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16815850 ↗
• InjuryJun 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. PATIENT HAD A RT TKA REVISION ON (B)(6) 2019, AND THEN HAD ANOTHER REVISION WITH POLY CHANGE ON (B)(6) 2019 EXCHANGING A PS RP INSERT FOR A CRS INSERT (MDR CASE NUMBER (B)(4)). THE SURGEON WANTED TO REMOVE THE SIZE 8 CRS FEMUR AND PUT IN EITHER A SIZE 9 OR 10 TO LOSE THE FLEXION GAP. THE SURGEON REMOVED THE FEMORAL COMPONENT. THE FEMORAL SLEEVE AND STEM STAYED IN THE FEMUR. THE SURGEON THEN TRIALED USING A SIZE 9 AND 10 FEMUR TO CLOSE THE FLEXION GAP. THE SURGEON FELT THAT THE SIZE 10 FEMUR WOULD BE THE BEST OPTION. IMPLANTS WERE OPEN ALONG WITH AUGMENTS. THE SURGEON CEMENTED THE FEMORAL COMPONENT IN PLACE AND FELT LIKE A SIZE 10 CRS 20MM INSERT GAVE THE BEST STABILITY IN EXTENSION AND FLEXION. NO SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10206845 ↗