ATTUNE 1547-04-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295382737), received between Sep 9, 2020 and Aug 3, 2026 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revised due to insufficient mcl and surgeon put in a hinge.DOI: (b)(6) 2025,DOR: (b)(6) 2026,Affected side: Right knee.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 50119279 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS RE-IMPLANTED FOLLOWING THE REMOVAL OF AN ANTIBIOTIC SPACER. PATIENT FELL WHEN THEY GOT HOME THE NEXT DAY CAUSING THE MCL TO BE COMPROMISED. PATIENT WAS BROUGHT BACK FOR SURGERY AND ALL FEMORAL COMPONENTS WERE REMOVED AND A SROM HINGE WAS PLACED. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 19761840 ↗
• InjurySep 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REQUIRED FIRST STAGE RIGHT TOTAL KNEE REVISION FOR A FUNGAL INFECTION OF THE RIGHT KNEE. PT ALREADY HAD IN SITU ATTUNE REVISION IMPLANTS, REQUIRING FULL EXTRACTION OF THE PROSTHESIS.

  Patient problems: Unspecified Infection

  MAUDE report 15493872 ↗
• InjurySep 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REQUIRED FIRST STAGE RIGHT TOTAL KNEE REVISION FOR A FUNGAL INFECTION OF THE RIGHT KNEE. PT ALREADY HAD IN SITU ATTUNE REVISION IMPLANTS, REQUIRING FULL EXTRACTION OF THE PROSTHESIS.

  Patient problems: Unspecified Infection

  MAUDE report 15493813 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF ATTUNE REVISION DUE TO PAIN AT THE DISTAL TIP OF THE STEM IN THE TIBIA. PATIENT VERY UNHAPPY AND SURGEON PLANNED TO REVISE THE TIBIA COMPONENT, BUT THEN NEEDED TO CHANGE THE FEMORAL COMPONENT ALSO. PATIENT HAS HAD MULTIPLE SURGERIES (B)(6) 2021 THEN AGAIN ON (B)(6) 2021. THIS PC IS THE THIRD REVISION. DOI: UNKNOWN. DOR (1ST): (B)(6) 2021 (REVISION OF COMPETITOR PRODUCTS). DOR (2ND): (B)(6) 2021. DOR (3RD): (B)(6) 2022.

  Patient problems: Pain

  MAUDE report 13869222 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF ATTUNE REVISION DUE TO PAIN AT THE DISTAL TIP OF THE STEM IN THE TIBIA. PATIENT VERY UNHAPPY AND SURGEON PLANNED TO REVISE THE TIBIA COMPONENT, BUT THEN NEEDED TO CHANGE THE FEMORAL COMPONENT ALSO. PATIENT HAS HAD MULTIPLE SURGERIES (B)(6) 2021 THEN AGAIN ON (B)(6) 2021. THIS PC IS THE THIRD REVISION. DOI: UNKNOWN DOR (1ST): (B)(6) 2021 (REVISION OF COMPETITOR PRODUCTS). DOR (2ND): (B)(6) 2021. DOR (3RD): (B)(6) 2021.

  Patient problems: Pain

  MAUDE report 13868985 ↗
• InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SMALL FRACTURE LINE THAT APPEARED IN X-RAYS WAS IN THE BONE.

  Patient problems: Limb Fracture

  MAUDE report 12063545 ↗
• InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SMALL FRACTURE LINE THAT APPEARED IN X-RAYS WAS IN THE BONE.

  Patient problems: Limb Fracture

  MAUDE report 12063526 ↗
• InjurySep 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED KNEE. REMOVAL OF IMPLANTS WAS PERFORMED. DOI: (B)(6) 2020. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10507306 ↗
• InjurySep 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED KNEE. REMOVAL OF IMPLANTS WAS PERFORMED. DOI: (B)(6) 2020. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10507302 ↗