ATTUNE 1504-00-124Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295041139), received between Jan 18, 2021 and Jun 4, 2026 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO AN INJURY THAT RESULTED IN MCL INSTABILITY REQUIRING A MORE CONSTRAINED PROSTHESIS. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 25391274 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTION AT 10 WEEK FOLLOW UP APPOINTMENT. KNEE WAS ASPIRATED AND CAME BACK POSITIVE FOR INFECTION. THE DOCTOR DECIDED TO EXPLANT THE TOTAL KNEE AND GAVE THE PATIENT A TEMPORARY ANTIBIOTIC SPACER UNTIL INFECTION IS CLEARED. ONCE INFECTION IS CLEARED, PATIENT WILL BE REVISED TO ATTUNE REVISION COMPONENTS. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23302189 ↗
• InjuryJun 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN EXPLANATION OF LEFT TOTAL KNEE ARTHROPLASTY WITH PLACEMENT OF TEMPORARY ANTIBIOTIC-LOADED SPACER TO ADDRESS RECURRENT CHRONIC INFECTION. DEPUY PRODUCTS WERE PLACED DURING THIS PROCEDURE. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17151342 ↗
• InjuryJan 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SECOND MANIPULATIONS OF KNEE UNDER ANESTHESIA: ARTHROFIBROSIS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE AND IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021, DATE OF EVENT (ONSET): (B)(6) 2021, (LEFT KNEE). TREATMENT: KNEE MANIPULATION. PRE-MANIPULATION (IN DEGREES): EXTENSION: 15. HYPEREXTENSION FLEXION: 70. POST-MANIPULATION (IN DEGREES): EXTENSION: 0. HYPEREXTENSION FLEXION: 120.

  Patient problems: Adhesion(s); Joint Laxity

  MAUDE report 13266093 ↗
• InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS ACHING, INSTABILITY AND LOOSENING OF THE TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. CEMENT WAS GREEN IN COLOR NO MANUFACTURE KNOWN. SURGEON NOTED KNEE WAS UNSTABLE AND PCL WAS FIBROUS BUT NOT COMPETENT. DOI: (B)(6) 2012 , DOR: (B)(6) 2021 ,(LEFT KNEE).

  Patient problems: Adhesion(s); Joint Laxity; Pain

  MAUDE report 13043288 ↗
• InjuryOct 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ARTHROFIBROSIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE AND IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021. DATE OF EVENT (ONSET): (B)(6) 2021. (LEFT KNEE). TREATMENT: KNEE MANIPULATION UNDER ANESTHESIA ON (B)(6) 2021.

  Patient problems: Adhesion(s)

  MAUDE report 12573888 ↗
• InjuryJan 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITERATURE ARTICLE ENTITLED, ¿DOES CIRCUMFERENTIAL PATELLAR DENERVATION RESULT IN DECREASED KNEE PAIN AND IMPROVED PATIENT-REPORTED OUTCOMES IN PATIENTS UNDERGOING NON-RESURFACED, SIMULTANEOUS BILATERAL TKA?¿ BY NICOLAAS C. BUDHIPARAMA MD, ET AL, PUBLISHED BY CLINICAL ORTHOPAEDICS RELATED RESEARCH (2020), VOL. 428, PP. 2020-2033 WAS REVIEWED. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE EFFICACY OF PATELLAR DENERVATION IN 78 PATIENTS RECEIVING BILATERAL ATTUNE PRIMARY TKAS WITHOUT PATELLAR RESURFACING BETWEEN FEB 2015 AND OCTOBER 2016. IN ALL BILATERAL PROCEDURES, THE PATELLAR DENERVATION VIA CAUTERIZATION OF THE PATELLAR RIM WAS ALWAYS PERFORMED ON THE RIGHT KNEE. THE AUTHORS CONCLUDED THAT THERE WAS NO CLINICAL DIFFERENCE BETWEEN THE CAUTERIZED AND NON-CAUTERIZED KNEES. PATIENT 2: DOI (B)(6) 2016. PATIENT RECEIVED A BILATERAL PRIMARY ATTUNE TKA TO TREAT OSTEOARTHRITIS OF KNEE GRADE 4. THE PATELLA WAS NO RESURFACED AND SMARTSET GENTAMYCIN CEMENT X1 WAS UTILIZED. SURGERY PERFORMED USING MEDIAL PARAPATELLAR STANDARD APPROACH AND HYBRID METHOD (MEASURED RESECTION + GAP BALANCING) USED FOR CUTTING AND ROTATIONAL REFERENCE TOWARD MECHANICAL AXIS. THE PROCEDURE WAS COMPLETED WITHOUT CO

  Patient problems: Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 11186971 ↗