ATTUNE 1523-03-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295057543), received between May 30, 2018 and Aug 12, 2025 — classified as 13 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (5 reports).

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT'S PRIMARY KNEE WAS DONE. THE PATIENT BEGAN TO HAVE PAIN IN TIBIA. UPON LOOKING AT XRAYS, THE SURGEON DETERMINED THE TIBIAL STEM WAS THROUGH THE LATERAL CORTEX. THE PATIENT UNDERWENT REVISION SURGERY. THE ENTIRE TIBIAL COMPONENT AND POLY WAS REMOVED, A TOTAL OF FIVE IMPLANTS. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 22784425 ↗
• InjuryApr 22, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR LOOSENING OF COMPONENTS OF LEFT KNEE. DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: POSSIBLY. PROCEDURE RELATED: POSSIBLY. DATE OF EVENT: (B)(6) 2025. DATE OF IMPLANT: (B)(6) 2020. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: NO INTERVENTION/TREATMENT AT THIS TIME. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150440104. LOT NUMBER ID: J3198U. COMPONENT TYPE: FEMORAL COMPONENT. DEVICE IDENTIFIER: (B)(6). CATALOG NUMBER: 151316110. LOT NUMBER ID: J2332W. COMPONENT TYPE: FEMORAL STEM. DEVICE IDENTIFIER: (B)(6). CATALOG NUMBER: 154904001. LOT NUMBER ID: J32A89. COMPONENT TYPE: FEMORAL MEDIAL POSTERIOR AUGMENT. DEVICE IDENTIFIER: (B)(6). CATALOG NUMBER: 154904002. LOT NUMBER ID: J4629Y. COMPONENT TYPE: FEMORAL LATERAL POSTERIOR AUGMENT. DEVICE IDENTIFIER: (B)(6). CATALOG NUMBER: 150660004. LOT NUMBER ID: 9113354. COMPONENT TYPE: TIBIAL BASE COMPONENT. DEVICE IDENTIFIER: (B)(6). CATALOG NUMBER: 151214030. LOT NUMBER ID: J5202D. COMPONENT TYPE: TIBIAL STEM. DEVICE IDENTIFIER: (B)(6). CATALOG NUMBER: 151302000. LOT NUMBER ID: 8596354. COMPONENT TYPE: FEMORAL STEM OFFSET AD

  Patient problems: Insufficient Information

  MAUDE report 21882406 ↗
• InjuryApr 22, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6), STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR LOOSENING OF COMPONENTS OF LEFT KNEE DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: POSSIBLY, PROCEDURE RELATED: POSSIBLY, DATE OF EVENT: 29-JAN-2025, DATE OF IMPLANT: (B)(6) 2020, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: NO INTERVENTION/TREATMENT AT THIS TIME. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150440104, LOT NUMBER ID: J3198U, COMPONENT TYPE: FEMORAL COMPONENT, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 151316110, LOT NUMBER ID: J2332W, COMPONENT TYPE: FEMORAL STEM, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 154904001, LOT NUMBER ID: J32A89 , COMPONENT TYPE: FEMORAL MEDIAL POSTERIOR AUGMENT, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 154904002, LOT NUMBER ID: J4629Y, COMPONENT TYPE: FEMORAL LATERAL POSTERIOR AUGMENT, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 150660004, LOT NUMBER ID: 9113354, COMPONENT TYPE: TIBIAL BASE COMPONENT, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 151214030, LOT NUMBER ID: J5202D, COMPONENT TYPE: TIBIAL STEM, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 151302000 , LOT NUMBER ID: 8596354, COMPONENT TYPE: FEMORAL STEM OFFSET A

  Patient problems: Insufficient Information

  MAUDE report 21882367 ↗
• InjuryFeb 19, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT A RIGHT KNEE COMPLETE SECOND REVISION WAS PERFORMED DUE TO FEMORAL AND TIBIAL LOOSENING AT THE CEMENT/IMPLANT INTERFACE. PATIENT EXPERIENCED PAIN AND REQUIRED HARDWARE REMOVAL DUE TO LOOSENING. CEMENT NOT FROM DEPUY.

  Patient problems: Pain

  MAUDE report 21409619 ↗
• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAINFUL (TKA) TOTAL KNEE ARTHROPLASTY. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED. DOI- UNKNOWN. DOR- (B)(6) 2024. AFFECTED SIDE- UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 21154296 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE CORRECT AFFECTED SIDE INVOLVED IN THIS EVENT WAS THE LEFT KNEE. THE RIGHT KNEE WAS A MISTAKE.

  Patient problems: Unspecified Infection

  MAUDE report 17400540 ↗
• InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ACUTE BLOOD LOSS ANEMIA. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2018. DATE OF EVENT: (B)(6) 2018. (LEFT KNEE). TREATMENT: INJECTED MEDICATION.

  Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16609057 ↗
• InjuryJul 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, REMOVAL OF THE TOTAL JOINT PROSTHESIS AND AN INSERTION OF AN ANTIBIOTIC SPACER DUE TO INFECTION WAS DONE. THERE WAS A LOOSENING OF THE FEMUR AND TIBIA IN THE BONE TO CEMENT INTERPHASE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15098295 ↗
• InjuryJul 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, REMOVAL OF THE TOTAL JOINT PROSTHESIS AND AN INSERTION OF AN ANTIBIOTIC SPACER DUE TO INFECTION WAS DONE. THERE WAS A LOOSENING OF THE FEMUR AND TIBIA IN THE BONE TO CEMENT INTERPHASE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15098280 ↗
• InjuryDec 2, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  CLINICAL ADVERSE EVENT RECEIVED FOR TIBIAL DISLOCATION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS PROBABLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020; DATE OF EVENT (ONSET): (B)(6) 2021; (RIGHT KNEE). TREATMENT: KNEE REVISION (B)(6) 2021. THE CLINICAL DATABASE NOW REPORTS THAT THERE HAS BEEN A KNEE REVISION--RIGHT KNEE WAS REVISED FOR LOOSENING TIBIAL COMPONENT, RIGHT KNEE--THAT OCCURRED ON (B)(6) 2021. TIBIAL TRAY, TIBIAL INSERT, TIBIAL STEM, OFFSET ADAPTOR, AND TIBIAL AUGMENT WERE REPORTEDLY REVISED--FEMUR AND PATELLA COMPONENTS WERE RETAINED.

  Patient problems: Insufficient Information

  MAUDE report 12915554 ↗
• InjuryJun 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DEEP VENOUS THROMBOSIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020. DATE OF EVENT (ONSET): (B)(6) 2020. (LEFT KNEE) TREATMENT: ORAL MEDICATION (UNSPECIFIED)

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11971148 ↗
• InjuryMay 7, 2021Loss of or Failure to Bond; Loose or Intermittent Connection; Loss of or Failure to Bond

  CLINICAL ADVERSE EVENT RECEIVED FOR LOOSENING TIBIAL CONSTRUCT, RIGHT KNEE EVENT IS SERIOUS AND IS CONSIDERED SEVERE EVENT IS DEFINITELY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020 DATE OF EVENT (ONSET): (B)(6) 2021 (RIGHT KNEE) TREATMENT: REVISION ON (B)(6) 2021, OF FEMUR, TIBIAL TRAY, TIBIAL INSERT, TIBIAL AUGMENT, TIBIAL STEM, TIBIAL OFFSET ADAPTOR; PATELLA RETAINED

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 11790981 ↗
• InjuryFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND FRACTURED HER TIBIA. THE SURGEON REMOVED THE IMPLANT, PLACED A PLATE ON THE TIBIA AND REPLACED WITH NEW IMPLANTS. DOI: (B)(6) 2019. DOR: (B)(6) 2020. RIGHT KNEE.

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

  MAUDE report 9712729 ↗
• MalfunctionApr 2, 2019Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE AUGMENT SCREWS WOULD NOT GO IN STRAIGHT AND GOT STUCK. HAD TO OPEN NEW IMPLANTS. ONE OF THEM ALSO GOT STUCK. THEY WERE ABLE TO IMPLANT THE SECOND SET OF IMPLANTS BUT NO CONFIDENCE THAT AUGMENT WAS PROPERLY LOCKED. ARTICULATING SCREWDRIVER IN ATTUNE REVISION SET DOES NOT WORK EFFECTIVELY. NEED A DIFFERENT OPTION. DOE: (B)(6) 2019, RIGHT KNEE.

  Patient problems: Not Applicable

  MAUDE report 8473154 ↗
• MalfunctionMay 30, 2018Connection Problem; Material Deformation; Connection Problem; Material Deformation

  DER STATES THAT THE SCREW IN THE SIZE 3 5MM WEDGE BECAME CROSS THREAD WITH THE TRAY. THE SCREW WAS DAMAGED AND COULD NOT BE REMOVED. WE HAD TO WASTE THE TRAY AND THE TWO WEDGES. DOI: UNKNOWN; DOR: (B)(6) 2018.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7553363 ↗