ATTUNE 1504-11-226Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295042136), received between Sep 15, 2020 and Jan 6, 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 16, 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.

• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STAGE 1 KNEE REVISION WAS PERFORMED DUE TO INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23983229 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: IT WAS A SIZE 4 RP TIBIAL TRAY. AND THERE WERE NO ALLEGATIONS AGAINST THE IMPLANTS THE PATIENTS MCL TORE AFTER INITIAL IMPLANTATION WHICH IS WHY WE TOOK EVERYTHING OUT AND PUT IN REVISION PARTS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20406278 ↗
• InjuryApr 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR QUADRICEPS TENDINOPATHY. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2020. DATE OF EVENT: (B)(6) 2022. (RIGHT KNEE). TREATMENT: INJECTION OF LOCAL ANESTHETIC AND CORTISONE.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 19061834 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD BILATERAL FRACTURES OF THE LATERAL FEMORAL CONDYLES. DOI: (B)(6) 2024 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 18969603 ↗
• InjuryAug 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INTERMITTENT SHOOTING PAIN TO STUDY KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2020, DATE OF EVENT: (B)(6) 2022, RIGHT KNEE. TREATMENT: INJECTION OF LOCAL ANESTHETIC AND CORTISONE TO STUDY KNEE.

  Patient problems: Pain

  MAUDE report 15240629 ↗
• InjuryJan 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR JOINT STIFFNESS. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020; DATE OF EVENT (ONSET): (B)(6) 2020; (RIGHT KNEE). TREATMENT: PHYSICAL THERAPY AND MANIPULATION UNDER ANESTHESIA.

  Patient problems: Muscular Rigidity

  MAUDE report 13342458 ↗
• InjuryMay 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR MEDICAL DEVICE SITE JOINT PAIN. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020. DATE OF EVENT (ONSET): (B)(6) 2020. (RIGHT KNEE). TREATMENT: PHYSICAL THERAPY, AND MANIPULATION OF KNEE UNDER ANESTHESIA.

  Patient problems: Pain

  MAUDE report 11766748 ↗
• InjuryJan 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SAPHENOUS NERVE NEUROPHATHY RIGHT LEG. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2020. DATE OF EVENT: (B)(6) 2020 (RIGHT KNEE).

  Patient problems: Nerve Damage

  MAUDE report 11229110 ↗
• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR CHRONIC AND WORSENING POST OPERATIVE KNEE PAIN. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2020,(RIGHT KNEE). TREATMENTS: PHYSICAL THERAPY, MANIPULATION OF KNEE UNDER ANESTHESIA.

  Patient problems: No Code Available; Pain

  MAUDE report 10581107 ↗
• InjurySep 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT DEEP VEIN THROMBOSIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020 DATE OF EVENT (ONSET): (B)(6) 2020 (RIGHT KNEE).

  Patient problems: No Code Available; Thrombosis

  MAUDE report 10537887 ↗