ATTUNE 1504-40-103Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295042167), received between Feb 21, 2020 and Oct 16, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Noise, Audible” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR PERSISTENT PAIN IN LEFT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2021 DATE OF EVENT: 01 DEC 2021 (LEFT KNEE). TREATMENT: ORAL MEDICATION AND DIAGNOSTIC INTERVENTION TREATMENT/IMPACT: INJECTED MEDICATION. DEPUY PRODUCTS USED (NO REVISION COMPLETED): DEVICE LOG FORM LOG LINE: 1 COMPONENT TYPE: FEMORAL COMPONENT CATALOG NUMBER: 150440103 LOT NUMBER ID: JC2497 DEVICE IDENTIFIER: (B)(4). DEVICE LOG FORM LOG LINE: 2 COMPONENT TYPE: TIBIAL BASE COMPONENT CATALOG NUMBER: 150640003 LOT NUMBER ID: 9773729 DEVICE IDENTIFIER: (B)(4). DEVICE LOG FORM LOG LINE: 3 COMPONENT TYPE: TIBIAL STEM CATALOG NUMBER: 151214030 LOT NUMBER ID: D21063066 DEVICE IDENTIFIER: (B)(4). DEVICE LOG FORM LOG LINE: 4 COMPONENT TYPE: TIBIAL INSERT COMPONENT CATALOG NUMBER: 151700312 LOT NUMBER ID: J03P07 DEVICE IDENTIFIER: (B)(4). DEVICE LOG FORM LOG LINE: 5 COMPONENT TYPE: CEMENT CATALOG NUMBER: 66017750 LOT NUMBER ID: 97671012 DEVICE IDENTIFIER: (B)(4). DEVICE LOG FORM LOG LINE: 6 COMPONENT TYPE: CEMENT CATALOG NUMBER: 66017750 LOT NUMBER ID: 97714988 DE

  Patient problems: Pain

  MAUDE report 23309629 ↗
• InjuryMar 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR NEUROLOGICAL PAIN NERVUS INFRAPATELLARIS LEFT KNEE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE; EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021 DATE OF EVENT (ONSET): (B)(6) 2022 (LEFT KNEE). TREATMENT: NEURECTOMY NERVUS INFRAPATELLARIS.

  Patient problems: Pain

  MAUDE report 13653185 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  CLINICAL ADVERSE EVENT RECEIVED FOR DEEP VENOUS THROMBOSIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021. DATE OF EVENT (ONSET): (B)(6) 2021. (LEFT KNEE). TREATMENT: ORAL MEDICATION (UNSPECIFIED).

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12167542 ↗
• InjuryAug 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SMALL FISSURE FRACTURE ANTERIOR FEMUR, OCCURRED DURING PRIMARY SURGERY. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2020, (LEFT KNEE). TREATMENT: FEMUR CERCLAGE ORIF DURING INITIAL SURGERY.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 10447776 ↗
• MalfunctionFeb 21, 2020Noise, Audible; Patient Device Interaction Problem; Noise, Audible; Patient Device Interaction Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PATELLAR CLUNK SYNDROME OR TENDONOSIS QUADRICEPS EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE THERE IS A REMOTE POSSIBILITY THE EVENT IS RELATED TO THE DEVICE AND PROBABLY RELATED TO THE PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018; DATE OF EVENT (ONSET): (B)(6) 2019; (LEFT KNEE).

  Patient problems: No Code Available

  MAUDE report 9739016 ↗