ATTUNE 1506-00-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 233 adverse event reports that list this exact device (DI 10603295042426), received between Sep 22, 2017 and Aug 12, 2026 — classified as 230 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (182 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 25 most recent of 233 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2026Loss of or Failure to Bond

  It was reported that the patient was revised due to pain, instability and loosening of the tibial component at the cement to implant interface. DePuy cement was used. DOI: UnknownDOR: (b)(6), 2026Affected side: Unknown

  Patient problems: Joint Laxity; Pain

  MAUDE report 50224377 ↗
• InjuryJul 8, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT HAD A PS ATTUNE RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2016. PATIENT WAS REVISED TODAY FOR INSTABILITY AND ASEPTIC LOOSENING OF THE TIBIAL COMPONENT.AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25747895 ↗
• InjuryJun 4, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO TIBIA LOOSENING AT THE TIBIA CEMENT INTERFACE. DEPUY CEMENT WAS USED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 25390509 ↗
• InjuryMay 18, 2026Loss of or Failure to Bond

  IT WAS REPORTED ON (B)(6) 2017, PATIENT RECEIVED AN ATTUNE LEFT POSTERIOR STABILIZED, FIXED BEARING TOTAL KNEE REPLACEMENT, UTILIZING TRUMATCH TECHNOLOGY. THE SURGERY WAS COMPLETED SUCCESSFULLY, WITH NO COMPLICATIONS. DEPUY SMARTSET BONE CEMENT WAS USED. ON (B)(6) 2018, LEFT KNEE WAS REVISED TO ADDRESS LEFT KNEE TIBIAL IMPLANT LOOSENING, AT THE CEMENT TO IMPLANT INTERFACE. INTRAOPERATIVELY, THE FEMUR AND PATELLA WERE FOUND TO BE WELL-FIXED, BUT THE TIBIAL TRAY WAS GROSSLY LOOSE, COMPLETELY DEBONDED FROM THE CEMENT MANTLE, AT THE CEMENT TO IMPLANT INTERFACE. FEMUR, TIBIAL TRAY, AND TIBIAL INSERT WERE ALL REVISED, AND REPLACED WITH COMPETITOR REVISION COMPONENTS. THE DEPUY ATTUNE PATELLA WAS RETAINED. DOI: (B)(6) 2017. DOR: (B)(6) 2018 LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 25199779 ↗
• InjuryMay 7, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THEY WERE PLANNING ON DOING A POLY EXCHANGE DUE TO INFECTION BUT FOUND OUT THE TIBIA WAS LOOSE SO REMOVED FEMUR/TIBIA & POLY. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25110888 ↗
• InjuryApr 17, 2026Loss of or Failure to Bond; Use of Device Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO ASEPTIC TIBIAL LOOSENING AT CEMENT TO IMPLANT INTERFACE. TIBIAL IMPLANT WAS POSITIONED WITH A SLIGHT ANTERIOR SLOPE. TIBIA DEBONDED AT THE CEMENT/IMPLANT INTERFACE. ALL COMPONENTS WERE REMOVED. FEMUR WAS NOT LOOSE. NO DELAYS OR PT INJURY. DOI: (B)(6) 2014. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911905 ↗
• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22468212 ↗
• InjuryMay 8, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO LOOSE TIBIAL COMPONENT AND POLYETHYLENE WEAR. AT REMOVAL THERE WAS NO CEMENT REMAINING ON THE TIBIAL COMPONENT. UNKNOWN CEMENT MFG. IT IS UNKNOWN IF THE PATELLA WAS RESURFACED.

  Patient problems: Insufficient Information

  MAUDE report 21986404 ↗
• InjuryApr 21, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO TIBIA LOOSENING ON THE IMPLANT TO CEMENT INTERFACE. DEPUY CEMENT WAS USED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6), 2015 DOR: (B)(6), 2025 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21873232 ↗
• InjuryApr 1, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE TIBIA EXPLANTED AND REVISED DUE TO LOOSENING. THERE WAS A TIBIA LOOSENING AT CEMENT/IMPLANT INTERFACE. DOI: (B)(6) 2015 DOR: (B)(6) 2025 AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21739087 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INCREASING PAIN. FULL REVISION WAS PERFORMED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2014. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 21170963 ↗
• InjuryMay 1, 2024Adverse 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 EFFUSION IN RIGHT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2013 DATE OF EVENT: 11 SEP 2014 (RIGHT KNEE) TREATMENT: CULTURE TAKEN.

  Patient problems: Swelling/ Edema

  MAUDE report 19221567 ↗
• InjuryMar 26, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS.REASON FOR REVISION: PAIN & LOOSENING.

  Patient problems: Pain

  MAUDE report 18977446 ↗
• InjuryMar 15, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2017, THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY UTILIZING DEPUY SYNTHES IMPLANTS INCLUDING PATELLA AND CEMENT X 1. ON (B)(6) 2022, THE PATIENT UNDERWENT A RIGHT KNEE REVISION SECONDARY TO PAIN, JOINT INSTABILITY AND SUSPECTED TIBIAL TRAY LOOSENING. INTRAOPERATIVELY, SCAR TISSUE AND SYNOVITIS WAS IDENTIFIED. THE TIBIAL TRAY WAS LOOSE AT THE IMPLANT TO CEMENT INTERFACE. THERE WAS BONE LOSS NOTED ON THE POSTERIOR ASPECT OF THE FEMORAL CONDYLES. ALL COMPONENTS WERE REMOVED AND REVISED TO A COMPETITOR CONSTRUCT WITH EXCEPTION OF THE PATELLA THAT REMAINED IN SITU. (B)(6) 2017 DOI. (B)(6) 2022 DOR (RIGHT KNEE).

  Patient problems: Adhesion(s); Joint Laxity; Pain; Synovitis

  MAUDE report 18913224 ↗
• InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND INSTABILITY. DOI: (B)(6) 2016. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 18595528 ↗
• InjuryJul 21, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT UNDERWENT A RIGHT TOTAL KNEE REPLACEMENT IN 2017. APPROXIMATELY MID-2021, PATIENT BEGAN TO EXPERIENCE SEVERE PAIN IN THAT SAME KNEE. WHEN THE PAIN CONTINUED TO INCREASE, PATIENT CONTACTED THE SURGEON FOR SOME EXAMINATION AND X-RAYS. AFTER THE EXAMINATION, THE SURGEON DETERMINED THE PATIENT WAS A CANDIDATE FOR DEPUY ATTUNE FIRST GENERATION OFFICIAL COMPONENT DUE TO LOOSENING. DURING THE SURGERY, THE SURGEON FOUND THE DEPUY DEVICE HAD COME LOOSE AND WAS DEFINITELY THE SOURCE OF THE SEVERE PERSISTENT PAIN, INABILITY TO COMPLETE DAILY ROUTINE, MANY SLEEPLESS NIGHTS, AND THE NECESSITY OF GOING THROUGH YET ANOTHER KNEE REPLACEMENT SURGERY ON THE SAME KNEE. DOI: 2017. DOE: 2021. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 17372050 ↗
• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2014. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 17140527 ↗
• InjuryJun 7, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO ASEPTIC LOOSENING. DATE OF IMPLANT: (B)(6) 2012. DATE OF REVISION: (B)(6) 2023. (LEFT KNEE). TREATMENT: FEMORAL COMPONENT, TIBIAL COMPONENT, AND INSERT WERE REVISED.

  Patient problems: Insufficient Information

  MAUDE report 17079956 ↗
• InjuryApr 5, 2023Use of Device Problem; Use of Device Problem

  PATIENT WAS REVISED DUE TO LOOSE PATELLA; MALROTATION ON TIBIAL COMPONENT. CEMENT MANUFACTURER WAS UNKNOWN. SURGICAL DELAY WAS REPORTED UNKNOWN. DOI: (B)(6) 2017. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16682243 ↗
• InjuryFeb 15, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION COMPLETED DUE TO KNEE PAIN AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16378521 ↗
• InjuryOct 21, 2022Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  PATIENT UNDERWENT A SUCCESSFUL LEFT PRIMARY TKA UTILIZING ATTUNE IMPLANTS INCLUDING PATELLA AND SMARTSET CEMENT X 1 ON (B)(6) 2014. PATIENT WAS LATER REVISED ON (B)(6) 2022 FOR LOOSENING AND GROSS MIGRATION OF THE TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE. THE FEMORAL COMPONENT WAS ALSO REVISED BUT WAS WELL FIXED AND THERE WERE NO ALLEGATIONS AGAINST THE COMPONENT. INTRAOPERATIVE FINDINGS INCLUDED OSTEOLYSIS, BUT DID NOT STATE WHERE THE OSTEOLYSIS WAS FOUND. DOI: (B)(6) 2014. DOR: (B)(6) 2022 (LEFT KNEE).

  Patient problems: Insufficient Information

  MAUDE report 15649751 ↗
• InjuryOct 12, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: (B)(6) 2017. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15587028 ↗
• InjuryOct 3, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  REASON FOR REVISION: ASEPTIC TIBIAL LOOSENING.

  Patient problems: Insufficient Information

  MAUDE report 15528100 ↗
• InjuryAug 30, 2022Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO ASEPTIC LOOSENING, PAIN, AND STIFFNESS. DATE OF IMPLANT: (B)(6) 2013. DATE OF REVISION: (B)(6) 2022. (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, TIBIAL, AND INSERT WERE REMOVED.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 15321062 ↗
• InjuryAug 5, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO LOOSENING OF TIBIAL TRAY AT CEMENT TO IMPLANT INTERFACE. UNKNOWN BONE CEMENT WAS USED. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15174018 ↗