ATTUNE 1547-04-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295382720), received between Mar 18, 2021 and Jul 17, 2024 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 19761816 ↗
• InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A PAINFUL KNEE. DOI: (B)(6) 2019. DOR:(B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15379052 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN NOT RESOLVING AS EXPECTED IN KNEE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS PROBABLY RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019; DATE OF EVENT (ONSET): (B)(6) 2021; DATE OF REVISION: (B)(6) 2022; (RIGHT KNEE). TREATMENT: THE REVISION OCCURRED ON (B)(6) 2022. THE CLINICAL DATABASE INDICATES THE FEMORAL SIDE DEVICES AND INSERT WERE REVISED.

  Patient problems: Pain

  MAUDE report 14140924 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN NOT RESOLVING AS EXPECTED IN KNEE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS PROBABLY RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019; DATE OF EVENT (ONSET): (B)(6) 2021; DATE OF REVISION: (B)(6) 2022 (RIGHT KNEE). TREATMENT: THE REVISION OCCURRED ON (B)(6) 2022. THE CLINICAL DATABASE INDICATES THE FEMORAL SIDE DEVICES AND INSERT WERE REVISED.

  Patient problems: Pain

  MAUDE report 14140922 ↗
• InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR POST-OPERATIVE ANEMIA. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2021, DATE OF EVENT: (B)(6) 2021, (LEFT KNEE). TREATMENT: BLOOD TRANSFUSION.

  Patient problems: Anemia

  MAUDE report 12234488 ↗
• InjuryJun 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PERSISTING PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS PROBABLY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2020. (LEFT KNEE) TREATMENT: INJECTED AND ORAL MEDICATIONS (UNSPECIFIED), PHYSICAL THERAPY

  Patient problems: Pain

  MAUDE report 11934153 ↗
• InjuryJun 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PERSISTING PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS PROBABLY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2020. (LEFT KNEE) TREATMENT: INJECTED AND ORAL MEDICATIONS (UNSPECIFIED), PHYSICAL THERAPY

  Patient problems: Pain

  MAUDE report 11934146 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. REMOVED ALL COMPONENTS AND PUT IN A TEMPORARY ANTIBIOTIC KNEE SPACER. NO SURGICAL DELAY. DOI: (B)(6) 2019; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11517226 ↗