ATTUNE 1504-01-108Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295041375), received between Nov 15, 2019 and May 15, 2025 — 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.

• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME BACK FOR A REVISION DUE TO LIMITED RANGE OF MOTION FROM HIS TOTAL KNEE. ALL COMPONENTS, BESIDES PATELLA WERE REMOVED AND A CRS RP REVISION WAS PERFORMED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THE SURGICAL DELAY IS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 22031725 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21878221 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A. CAN YOU PLEASE CONFIRM IF THE PATELLA IS REFERRED TO AS THE BONE OR THE IMPLANT? - BONE B. PLEASE CONFIRM WHAT WAS FRACTURED, WAS IT A BONE FRACTURE (PLEASE INDICATE IF IT WAS ACETABULAR OR FEMORAL) OR AN IMPLANT FRACTURE (PLEASE SPECIFY WHAT IMPLANT)? ¿ BONE FRACTURE UNDER THE IMPLANT.

  Patient problems: Joint Laxity; Pain

  MAUDE report 19605600 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SINGLE STAGE REVISION FOR AN ACUTE INFECTION. ATTUNE IMPLANTS WERE REMOVED, WOUND I&D, AND NEW ATTUNE IMPLANTS WERE USED. IMPLANTS ARE UNAVAILABLE FOR RETURN AND THERE WAS NO DELAY IN THE PROCEDURE. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17730281 ↗
• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR HEMARTHROSIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE). TREATMENT: ASPIRATION; 20 CC OF BLOOD ASPIRATED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16742425 ↗
• 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 10831418 ↗
• InjuryNov 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO KNEE INSTABILITY, ALL COMPONENTS EXCEPT THE PATELLA WERE REMOVED AND REVISED. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10830683 ↗
• InjuryAug 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR HEMATOMA PURULENT FLOW ON LEFT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED SEVERE. EVENT IS NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2019; (LEFT KNEE).

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Code Available; Purulent Discharge

  MAUDE report 10408275 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS POOR RANGE OF MOTION. FEMUR WAS REVISED. DOI: (B)(6) 2019; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 9849111 ↗
• InjuryNov 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT LEG THROMBOSIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE.

  Patient problems: Edema; Muscular Rigidity; No Code Available; Pain; Rash; Thrombosis; Unspecified Infection

  MAUDE report 9328239 ↗