ATTUNE 1523-03-102Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295057550), received between Mar 14, 2019 and Jan 13, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (3 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 8 most recent of 8 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 24051346 ↗
• InjuryDec 12, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  UPDATES RECEIVED: TREATMENT/IMPACT: OTHER: TRUE. IF OTHER ¿ SPECIFY: PLANNED TO HAVE REVISION SURGERY IN (B)(6) OF 2026.

  Patient problems: Insufficient Information

  MAUDE report 23788982 ↗
• InjuryNov 14, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL EVENT INFORMATION REVIEWED AND RECEIVED ON 04-NOV-2025 AND 03-NOV-2025: UPDATES RECEIVED: DEVICE RELATED: POSSIBLY. PROCEDURE RELATED: DEFINITELY. CLINICAL UPDATE RECEIVED ON 26 NOV 2025: UPDATES RECEIVED: DIAGNOSIS: LATERAL KNEE PAIN ON LEFT KNEE FOUND TO HAVE TIBIAL AND FEMORAL COMPONENT LOOSENING: LATERAL KNEE PAIN. ADDITIONAL EVENT INFORMATION REVIEWED AND RECEIVED: CLINICAL ADVERSE EVENT RECEIVED FOR TIBIAL AND FEMORAL COMPONENT LOOSENING ON INDEX KNEE. TREATMENT/IMPACT: OTHER (PLANNED TO HAVE REVISION SURGERY IN (B)(6) 2026).

  Patient problems: Pain

  MAUDE report 23554420 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR:(B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21938201 ↗
• InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT HAS HAD FIVE PRIOR KNEE REVISION PROCEDURES ON THIS KNEE. DURING THIS PROCEDURE, THE PATIENT'S REVISION COMPONENTS WERE REMOVED DUE TO INFECTION. A STATIC SPACE, MADE OF ANTIBIOTIC BONE CEMENT AND STEINMANN PINS, WERE IMPLANTED TO SPAN THE PATIENT'S KNEE UNTIL HER INFECTION HAS CLEARED. THERE WAS NO SURGERY TIME EXTENDED. DOI: (B)(6) 2023 (FEMORAL COMPONENTS) AND (B)(6) 2024 (TIBIAL COMPONENTS), DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21610504 ↗
• 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 19033315 ↗
• 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 11544139 ↗
• 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 8420560 ↗