ATTUNE 1513-10-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295043492), received between Jan 3, 2019 and Feb 12, 2026 — classified as 10 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (2 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO THE REMOVAL OF IMPLANTS FOR INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24327402 ↗
• InjuryOct 28, 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 CHRONIC RIGHT MEDIAL POSTERIOR KNEE PAIN DEVICE RELATED: REMOTE POSSIBILITY PROCEDURE RELATED: POSSIBLY DATE OF EVENT: 7 JAN 2025 DATE OF IMPLANT: (B)(6) 2022 DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: INJECTED MEDICATION, PHYSICAL THERAPY.

  Patient problems: Pain

  MAUDE report 23404919 ↗
• InjuryOct 21, 2025Migration; Migration

  IT WAS REPORTED THAT PATIENT'S DISTAL FEMORAL COMPONENT, SLEEVE, AND STEM SUBSIDED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 23351131 ↗
• InjuryJul 21, 2025Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THERE WAS A REVISION OF AN ATTUNE REVISION CONSTRUCT. REASON FOR REVISION DUE TO LOOSENING AT THE IMPLANT-BONE INTERFACE OF TIBIAL STEM, FEMORAL SLEEVE AND STEM RESULTING IN SUBSIDENCE. THESE IMPLANTS ARE CEMENTLESS. NO SIGN OF INFECTION. THE RIGHT SIDE WAS IMPACTED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22554087 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: (B)(6). CLINICAL ADVERSE EVENTS RECEIVED FOR KNEE STIFFNESS DEVICE AND PROCEDURE(RELATEDNESS) DEVICE RELATED: DEFINITELY PROCEDURE RELATED: DEFINITELY DATE OF EVENT: 16 SEP 2024 DATE OF IMPLANT: (B)(6) 2023 DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: LEFT TREATMENT/IMPACT: PHYSICAL THERAPY DEPUY SYNTHES PRODUCT USED: COMPONENT TYPE: FEMORAL COMPONENT CATALOG NUMBER: 150410105 LOT NUMBER ID: 3851774 DESCRIPTION: NO INFORMATION PROVIDED COMPONENT TYPE: TIBIAL BASE COMPONENT CATALOG NUMBER: 150680006 LOT NUMBER ID: 4022166 DESCRIPTION: NO INFORMATION PROVIDED COMPONENT TYPE: TIBIAL STEM CATALOG NUMBER: 151310110 LOT NUMBER ID: J8383W DESCRIPTION: NO INFORMATION PROVIDED COMPONENT TYPE: TIBIAL SLEEVE CATALOG NUMBER: 151111201 LOT NUMBER ID: J94Z36 DESCRIPTION: NO INFORMATION PROVIDED COMPONENT TYPE: TIBIAL INSERT COMPONENT CATALOG NUMBER: 151650505 LOT NUMBER ID: 3787761 UDI: (B)(4) COMPONENT TYPE: CEMENT CATALOG NUMBER: 3003940002 LOT NUMBER ID: AX42AK0B03 DESCRIPTION: NO INFORMATION PROVIDED.

  Patient problems: Muscular Rigidity

  MAUDE report 20407199 ↗
• MalfunctionDec 13, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6). 2023, THE REVISION SURGERY WAS PERFORMED VIA TKA WITH THE STEM IN QUESTION. WHEN ASSEMBLING THE STEM IN QUESTION, IT MOVED POORLY AND STOPPED MIDWAY, SO ANOTHER STEM WAS USED INSTEAD. AN INVESTIGATION WAS REQUESTED DUE TO A DEFECT IN THE STEM IN QUESTION. IN ADDITION, THE PRIMARY SURGERY (DATE UNKNOWN) WAS PERFORMED USING ANOTHER COMPANY'S PRODUCT; NO JJ PRODUCT WAS USED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18317619 ↗
• InjuryMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS INFECTION, ALL REVISION PROSTHESIS WERE EXTRACTED AND AN ANTIBIOTIC STATIC SPACER WAS IMPLANTED. THE SAME SURGEON, PERFORMED BOTH SURGERIES. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. UNKNOWN SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 16655145 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A RIGHT TOTAL KNEE REPLACEMENT ON THE (B)(6) 2022 WHERE ATTUNE REVISION IMPLANTS WERE UTILISED. THE PATIENT PRESENTED FOR A REVISION PROCEDURE ON THE (B)(6) 2022 FOR AN UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 15579742 ↗
• MalfunctionOct 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER TAKING OUT A OFFSET ADAPTER FROM THE BOX, THE STAFF TRIED TO UNLOCK THE NUT FOR THE POSITIONING OF THE TIBIA. BUT THAT IMPLANT DOESN'T WORK AT ALL. AND THEN HE DECIDED TO CHANGE THE PROCESS. AT FIRST, HE ASSEMBLED THE STEM WITH OFFSET ADAPTER. SECOND, HE TRIED TO CHANGE THE OFFSET BUT THE OFFSET ADAPTER WAS STILL LOCKED AND THE STEM WAS ALSO LOCKED AS WELL. UNFORTUNATELY, HE TOOK OUT THE NEW IMPLANT. THERE WAS A 20 MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12680509 ↗
• MalfunctionApr 28, 2021Difficult to Advance; Difficult to Advance

  QUESTIONS: A. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? B. THE REPORTED PRODUCT "154900103" IS INVALID IN ECM AND AS400. PLEASE PROVIDE VALID PRODUCT AND/OR LOT NUMBER OF THE PRODUCT. C. PLEASE CLARIFY IF THE TRIALS PLAYED A PART IN THE SEATING ERRORS. D. PLEASE PROVIDE PRODUCT AND LOT NUMBER OF THE 12X110 STEM. ANSWERS FOR YOUR QUESTIONS: A. NOT THAT THE REP HAS BEEN INFORMED OF C. IN THE COPIED REPLIED STATEMENT IT IS CLEARLY NOTED THAT THE TRIAL CONSTRUCT WAS CONFIRMED TO SIT DOWN.

  Patient problems: Insufficient Information

  MAUDE report 11737039 ↗
• InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018 THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF RIGHT TIBIAL COMPONENT, PAIN, SUBSIDENCE OF TIBIAL TRAY, VARUS CONTRACTURE OF LEG, AND SYNOVITIS. ON (B)(6) 2018 PATIENT HAD AN I AND D FOR NECROTIC WOUND POSTERIOR MEDIAL ASPECT OF RIGHT KNEE. THE PATIENT HAD BEEN ON ORAL ANTIBIOTICS PRIOR TO PROCEDURE. ON (B)(6) 2019 THE PATIENT HAD A REVISION OF RIGHT TOTAL KNEE ARTHROPLASTY WITH REVISION OF BOTH TIBIAL AND FEMORAL COMPONENTS ALONG WITH A RIGHT POPLITEAL ARTERY THROMBECTOMY WITH FEMORAL POPLITEAL BYPASS DUE TO LOOSE TOTAL KNEE ARTHROPLASTY, RIGHT KNEE WITH POPLITEAL ARTERY THROMBUS AND PAIN. DOI: (B)(6) 2016 (PATELLAR AND FEMORAL COMPONENT); DOI: (B)(6) 2018 (TIBIAL TRAY, INSERT, STEM, AUGMENT AND BONE CEMENT); DOR: (B)(6) 2019 (RT KNEE).

  Patient problems: No Code Available; Pain; Thromboembolism

  MAUDE report 9566150 ↗
• InjuryOct 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLETE KNEE REVISION PERFORMED ON PATIENT TO ADDRESS PAIN IN TIBIA. ALL COMPONENTS REMOVED AND REPLACED WITH ATTUNE REVISION COMPONENTS TO INCLUDE STEMS AND SLEEVES ON BOTH FEMUR AND TIBIA. PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? REVISION OF THE PATIENT'S TOTAL KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9141254 ↗
• InjuryJan 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INTRAOPERATIVE FRACTURES OF TIBIA AND FEMUR.

  Patient problems: Bone Fracture(s)

  MAUDE report 8214261 ↗