ATTUNE 1520-20-405Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295542407), received between Jan 19, 2023 and May 29, 2026 — 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.

• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POLY UPSIZING. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 25334153 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. POLY WAS CHANGED TO 8MM. THAT IS ALL AVAILABLE INFO. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23468334 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN ACUTE INFECTION. THE SURGEON DID WASHOUT AND A POLY SWAP. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23304544 ↗
• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS KNEE REVISION PROCEDURE WAS THIS PATIENT'S SECOND REVISION PROCEDURE ON THE SAME KNEE. THE PATIENT'S KNEE WAS INITIALLY REVISED ON (B)(6) 2024 BECAUSE OF TIGHTNESS. HER PRIMARY ATTUNE TIBIAL INSERT WAS REMOVED AND AN LYSIS OF ADHESIONS PROCEDURE WAS PERFORMED TO REMOVE SCAR TISSUE. A THINNER REPLACEMENT TIBIAL INSERT WAS THEN IMPLANTED TO REDUCE THE TIGHTNESS. DURING THIS SECOND REVISION PROCEDURE, THE PATIENT'S TIBIAL INSERT WAS REMOVED AND ADDITION SCAR TISSUE WAS REMOVED. HER PATELLA WAS RESURFACED, WHICH HAD NOT BEEN PREVIOUSLY DONE DURING HER PRIMARY PROCEDURE OR HER PRIOR REVISION PROCEDURE. THE PATIENT HAD BEEN EXPERIENCING PAIN IN THE ANTERIOR PORTION OF HER KNEE, SO HOPEFULLY THE RESURFACING OF HER PATELLA WILL RESOLVE HER PAIN. A REPLACEMENT TIBIAL INSERT OF THE SAME SIZE AND THICKNESS WAS IMPLANTED. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Pain

  MAUDE report 21307460 ↗
• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS KNEE REVISION PROCEDURE WAS THIS PATIENT'S SECOND REVISION PROCEDURE ON THE SAME KNEE. THE PATIENT'S KNEE WAS INITIALLY REVISED ON (B)(6) 2024 BECAUSE OF TIGHTNESS. THE PRIMARY ATTUNE TIBIAL INSERT WAS REMOVED AND AN LYSIS OF ADHESIONS PROCEDURE WAS PERFORMED TO REMOVE SCAR TISSUE. A THINNER REPLACEMENT TIBIAL INSERT WAS THEN IMPLANTED TO REDUCE THE TIGHTNESS. DURING THIS SECOND REVISION PROCEDURE, THE PATIENT'S TIBIAL INSERT WAS REMOVED AND ADDITION SCAR TISSUE WAS REMOVED. PATELLA WAS RESURFACED, WHICH HAD NOT BEEN PREVIOUSLY DONE DURING THE PRIMARY PROCEDURE OR PRIOR REVISION PROCEDURE. THE PATIENT HAD BEEN EXPERIENCING PAIN IN THE ANTERIOR PORTION OF HER KNEE, SO HOPEFULLY THE RESURFACING OF THE PATELLA WILL RESOLVE THE PAIN. A REPLACEMENT TIBIAL INSERT OF THE SAME SIZE AND THICKNESS WAS IMPLANTED. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Muscular Rigidity

  MAUDE report 21307152 ↗
• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY OF KNEE, LARGER IMPLANT THICKNESS WAS NEEDED FOR THE INSERT TO ACHIEVE LEG STABILITY. DOI: (B)(6) 2024; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18826051 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OPERATIVE NOTES IDENTIFIED A PREVIOUSLY UNKNOWN POST-TKA RIGHT KNEE MANIPULATION UNDER ANESTHESIA WITH LYSIS OF ADHESIONS TO TREAT PAIN, REDUCED ROM, AND ADHESIONS ON (B)(6) 2022. THIS PROCEDURE WAS UNSUCCESSFUL, AND THE PATIENT WAS REFERRED FOR AN OPEN LYSIS OF ADHESIONS WITH AN INSERT REVISION. (B)(6) 2023: THE PATIENT RECEIVED A RIGHT KNEE LYSIS OF ADHESIONS WITH TIBIAL INSERT REVISION TO TREAT PAIN, STIFFNESS, AND REDUCED ROM. UPON ENTERING THE JOINT, DENSE SCAR TISSUE WAS DEBRIDED AND A SYNOVECTOMY AND QUADRICEPSPLASTY WERE PERFORMED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATELLA, FEMORAL COMPONENT, AND TIBIAL TRAY WERE RETAINED. THE PATIENT RECEIVED AN ATTUNE FB TIBIAL INSERT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THIS PROCEDURE IS A CONTINUATION OF THE SAME EVENT NOTED IN THE MUA ABOVE AND WILL NOT REQUIRE AN ADDITIONAL PC. DOI: (B)(6) 2021. DOE: (B)(6) 2022 (MUA). DOR: (B)(6) 2023 (INSERT REVISION).

  Patient problems: Adhesion(s); Loss of Range of Motion; Muscular Rigidity; Pain

  MAUDE report 18452681 ↗
• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE ARTHROFIBROSIS. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2022, DATE OF EVENT: (B)(6) 2023, (RIGHT KNEE). TREATMENT: MANIPULATION UNDER ANESTHESIA COMPLETED ON (B)(6) 2023.

  Patient problems: Adhesion(s)

  MAUDE report 16205291 ↗