ATTUNE 1523-03-202Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295057574), received between Mar 14, 2019 and Jan 13, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 18, 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.

• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS VERY SICK AND HAS FULL BODY INFECTION. PATIENT PRESENTED WITH BILATERAL KNEE AND SHOULDER INFECTIONS IN (B)(6) 2025 AND SURGEON WAS DOING EVERYTHING HE CAN TO CLEAR THE INFECTION. SURGEON ELECTED TO REMOVE DFR IMPLANT AND FUSE KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24051354 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FOLLOWING IMPLANTS SUBSIDED. RIGHT LPS DISTAL FEMUR, UNIVERSAL FEMORAL SLEEVE, LPS ADAPTER AND UNIVERSAL STEM SUB-SITED LEAVING PATIENTS LEG SHORT ON THAT RIGHT SIDE. ALSO THE ATTUNE REVISION TIBIA, ATTUNE REVISION TIBIAL SLEEVE AND STEM WERE LOOSE. SURGEON EXPLANTED ALL IMPLANTS EXCEPT THE PATELLA. SURGEON REVISED AND REPLACED THE IMPLANTS. THERE WAS LOOSENING OF ALL IMPLANTS AT THE BONE TO CEMENT INTERFACE. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Physical Asymmetry

  MAUDE report 19033324 ↗
• InjuryMar 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECORDS STATE THAT THE PATIENT UNDERWENT A R PRIMARY TOTAL KNEE ARTHROPLASTY IN 2019 USING UNKNOWN IMPLANTS. SHE THEN DEVELOPED A POSTOPERATIVE INFECTION REQUIRING A 1-STAGE EXCHANGE IN (B)(6) 2020 USING "TRUE COMPONENTS" OF UNKNOWN MANUFACTURER. THE CHRONIC INFECTION CONTINUED AND WAS CLEARED WITH ANTIBIOTICS. SHE UNDERWENT A FULL REVISION ON (B)(6) 2020 USING DEPUY COMPONENTS. PHYSICIAN CHECK-UP ON (B)(6) 2020 STATES SHE SUSTAINED A FALL AND CONTINUED TO HAVE PAIN, FLUID OVERLOAD AND REACTIVE CELLULITIS IN THE RIGHT LEG. ON (B)(6) 2021 AN MRI SHOWED NONDISPLACED FX OF THE RIGHT TIBIA ADJACENT TO THE STEM. PATIENT WAS TOLD TO USE A WALKING BOOT WITH WEIGHT RESTRICTIONS. A SEARCH OF THE CLINICAL DATABASE REVEALED NO INDICATION OF THE MANUFACTURER OF THE UNKNOWN IMPLANTS. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2021, (RIGHT KNEE).

  Patient problems: Fall; Pain

  MAUDE report 11544021 ↗
• 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 9712725 ↗
• 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 9566157 ↗
• 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 9141256 ↗
• InjuryMar 14, 2019Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  PATIENT REPORTED WITH PAINFUL AND UNSTABLE RIGHT TKA FROM AN OUTSIDE HOSPITAL WITH NO AVAILABLE OPERATIVE REPORT. XRAYS INDICATED A SUBSIDED AND LOOSE TIBIAL COMPONENT WITH A STEM EXTENSION APPEARING TO HAVE EXITED THE LATERAL TIBIAL CORTEX. THE SURGICAL PLAN WAS TO RETAIN THE WELL-FIXED FEMORAL COMPONENT AND REVISE ONLY THE TIBIAL COMPONENT AND INSERT. UPON EXPLANTING THE TIBIAL COMPONENT CONSTRUCT IT BECAME EVIDENT THAT THE COMPONENT WAS PREOPERATIVELY MISIDENTIFIED BY THE SURGICAL TEAM AS AN MBT REVISION TIBIA AND WAS ACTUALLY AN ATTUNE REVISION COMPONENT. NO INSTRUMENTS OR IMPLANTS WERE IMMEDIATELY AVAILABLE FOR THE ATTUNE SYSTEM. THE ATTENDING SURGEON, WHILE BEING ADVISED OF THE OFF-LABEL NATURE OF HIS DECISION, DECIDED IT WAS IN THE BEST INTERESTS OF THE PATIENT TO IMPLANT A SIGMA MBT REVISION RP 15MM BUILDUP TRAY AND TO MODIFY AND UTILIZE A SIGMA TC3 RP REVISION INSERT TO ARTICULATE WITH THE SIZE 3 ATTUNE REVISION FEMORAL COMPONENT WHICH RESULTED IN A STABLE OVERALL CONSTRUCT.

  Patient problems: No Code Available; Pain

  MAUDE report 8420576 ↗