ATTUNE 1504-10-226Recalls & reported problems

Summary

The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 10603295041856), received between Aug 8, 2017 and Jun 9, 2026 — classified as 80 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (15 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 83 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTED KNEE. ALL IMPLANTS WERE REMOVED; SPACER PLACED. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25448512 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR KNEE CONTRACTURE S/P TKA, DEVICE AND PROCEDURE (RELATEDNESS), DEVICE RELATED: POSSIBLY RELATED, PROCEDURE RELATED: POSSIBLY RELATED, DATE OF EVENT: 02 JUL 2014, DATE OF IMPLANT: (B)(6) 2014, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: HOSPITALIZATION, MANIPULATION UNDER ANESTHESIA. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150410226, LOT NUMBER ID: 428688, COMPONENT: FEMORAL, DESCRIPTION: ATTUNE KNEE SYSTEM FEMORAL POSTERIOR STABILIZED NARROW SIZE 6N RIGHT CEMENTED.

  Patient problems: Septic loosening

  MAUDE report 24079780 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ATTUNE PS FEM RT SZ 6 NAR CEM, ATTUNE RP TIB BASE SZ 5 CEM, ATTUNE MEDIAL ANAT PAT 35MM, AND ATTUNE PS RP INSRT SZ6 5MM WERE INVOLVED IN A REVISION OF AN ATTUNE KNEE SYSTEM DUE TO PERSISTENT PAIN FOLLOWING THE INITIAL PROCEDURE. ALTHOUGH TESTS FOR INFECTION AND LOOSENING WERE NEGATIVE, ELEVATED BLOOD MARKERS LED CLINICIANS TO TREAT THE CASE AS AN INFECTION, RESULTING IN A TWO-STAGE REVISION WHERE ALL COMPONENTS WERE EXPLANTED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23819018 ↗
• InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EXCESSIVE LAXITY IN EXTENSION AND DEFICIT IN FLEXION ON A TKA WITH ATTUNE FROM 2022. PATIENT EXPERIENCED REDUCED MOBILITY AND PAIN AND REQUIRED REVISION SURGERY.

  Patient problems: Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 23413376 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION THAT APPEARED TO BE OCCURRING FOR A WHILE. SURGEON DECIDED TO REMOVE IMPLANTS IMPLANT AN ANTIBIOTIC SPACER. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23393582 ↗
• InjuryAug 20, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ON AN UNKNOWN DATE 8 YEARS AGO, THE PATIENT UNDERWENT A TKA SURGERY NO RIGHT KNEE WITH THE IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY, THE IMPLANTS LOOSENING WAS CONFIRMED. ON (B)(6) 2025, THE REVISION SURGERY WAS PERFORMED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE SURGEON COMMENTED THAT THE OLD TIBIAL TRAY DID NOT HAVE A CEMENT POCKET, AND THAT DEBONDING OF THE TIBIAL BONE MAY HAVE LED TO LOOSENING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22850561 ↗
• InjuryJun 30, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. DOI: (B)(6) 2020. DOR: (B)(6) 2025. AFFECTED AREA: UNK KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22357566 ↗
• InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INVESTIGATOR INITIATED STUDY (IIS) DPS-JMP-2019-079. PATIENT RECEIVED ATTUNE IMPLANT AS PART OF THE STUDY. EVENT: DVT CALF R LEG START DATE: (B)(6) 2024 / SURGERY DATE: (B)(6) 2024 EVENT START DATE: 26 FEB 2024. AS NOTED ON SITE FORM: EVENT DID NOT OCCUR AT THE OPERATIVE SITE / THE INVESTIGATOR OPINION WAS THE EVENT WAS UNANTICIPATED, POSSIBLY RELATED TO THE PROCEDURE AND UNRELATED TO THE STUDY DEVICE I.E. ATTUNE IMPLANT / SEVERITY WAS LISTED AS MILD AND CONSIDERED SERIOUS. US RADIOLOGY CONFIRMED DVT (B)(6) 2024, PATIENT COMMENCED ON ELIQUIS 5MG X 2 BD FOR 1-WEEK / X1 BD FOR 2-WEEKS RESOLVED REVIEW ULTRASOUND(B)(6) 2024 OUTCOME NOTED AS 'RESOLVED, NO SEQUELAE' PATIENT WAS NOT WITHDRAWN FORM THE STUDY AS A RESULT OF THIS EVENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22117903 ↗
• InjuryMar 20, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIA AND FEMUR AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21655146 ↗
• InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: A- WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? B- CAN YOU CONFIRM IF DEPUY CEMENT WAS USED DURING THE PRIMARY SURGERY? IF YES, PLEASE PROVIDE THE PART AND LOT NUMBERS OF THE CEMENT. QUANTITY OF THE DEPUY CEMENT USED. -A. NO. B. THE SURGEON USES DEPUY CMWLL WITH GENTAMICIN 3325020. 2X MIXED. 1X FOR TIBIA. 1X FOR FEMUR AND PATELLA.

  Patient problems: Unspecified Infection

  MAUDE report 20496643 ↗
• InjuryOct 4, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE IMPLANTS BECAME LOOSE. DOI: (B)(6) 2016. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20370861 ↗
• InjuryAug 27, 2024Adverse 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. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 20077581 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME WITH STIFFNESS AND PAIN. THE SURGEON DECIDED IT BEST TO REMOVE THE FEMUR, DOWNSIZE AND IMPLANT A CRS FEMUR WITH A RPPS POLY. NO MORE PATIENT INFORMATION IS AVAILABLE AT THIS TIME. DOI: (B)(6) 2019; DOR: (B)(6) 2024; AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 19097877 ↗
• InjuryMar 8, 2024Loss of or Failure to Bond; Naturally Worn; Loss of or Failure to Bond; Naturally Worn

  THE PATIENT UNDERWENT A RIGHT PRIMARY KNEE REPLACEMENT ON (B)(6) 2016 UTILIZING ATTUNE IMPLANTS WITH NO INDICATION OF CEMENT MANUFACTURER. ON 13-JUL-2023, THE PATIENT BEGAN TO HAVE PAIN AND WAS LIMPING. XRAY REVIEW IDENTIFIED GROSS LOOSENING AND EARLY COLLAPSE OF THE RIGHT TIBIA. ON (B)(6) 2023, THE PATIENT WAS REVISED AND THE TRAY WAS CONFIRMED TO BE LOOSE AT THE IMPLANT TO CEMENT INTERFACE. DOI: (B)(6) 2016 DOR: (B)(6) 2023 (RIGHT KNEE).

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 18865924 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD DEVELOPED A FLEXION CONTRACTURE AND COULD NO LONGER ACHIEVE FULL EXTENSION. OPERATIVELY, IT WAS NOTED THAT THE PATIENT HAD A FLEXION EXTENSION MISMATCH. COMPONENTS WERE REMOVED AND A REVISION HINGED KNEE WAS PLACED UNEVENTFULLY. ALL COMPONENTS WERE APPROPRIATELY SIZED, WELL ALIGNED, WELL FIXED WITH AN APPROPRIATE JOINT LINE. NO DELAY OCCURRED AND NO PATIENT HARM WAS NOTED. CEMENT WAS HOSPITAL OWNED SO NO RECORDS ARE AVAILABLE. PATELLAR IMPLANT WAS RETAINED FROM INITIAL SURGERY AS IT WAS WELL FIXED AND TRACKED APPROPRIATELY. PATIENT DID HAVE AN ADDITIONAL SURGERY ON (B)(6) 2022 AND WAS CAPTURED IN (B)(4). THE INSERT WAS EXCHANGED AT THAT TIME, HOWEVER DUE TO A CHANGE FROM COMPASS TO OPTIMIZE IN OUR TERRITORY, FEW RECORDS OTHER THAN INSERT SIZE ARE CURRENTLY AVAILABLE. PLEASE NOTE THAT THE SAME SIZE INSERT WAS UTILIZED. NO LOT NUMBERS ARE AVAILABLE FOR THE SAME REASON. DOI: (B)(6) 2023, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Contracture; Loss of Range of Motion

  MAUDE report 18493088 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR FLEXION CONTRACTURE. DOI: (B)(6) 2020; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Contracture

  MAUDE report 18307463 ↗
• InjurySep 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AND INSTABILITY. A POLY EXCHANGE WAS ATTEMPTED, HOWEVER A FLEXION / EXTENSION MISMATCH WAS NOTED. A REVISION KNEE WAS PERFORMED UNEVENTFULLY. NO PATIENT HARM OCCURRED. COMPONENTS WERE APPROPRIATELY SIZED, WELL ALIGNED AND JOINT LINE WAS APPEARED APPROPRIATE. NO ALTERNATIVE TECHNIQUES HAD BEEN UTILIZED IN PREFORMING THE PRIMARY TKA. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT KNEE

  Patient problems: Joint Laxity; Pain

  MAUDE report 17824433 ↗
• InjuryMay 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2017, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16974223 ↗
• InjuryMar 17, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT THE UNKNOWN SURGERY FOR THIGHBONE WITH THE PRODUCT IN QUESTION. THE PATIENT WAS FINE FOR ONE YEAR AFTER THE SURGERY, AND THE COURSE OF THE DISEASE AFTER THAT WAS UNKNOWN. THE ONSET OF PAIN REVEALED LOOSENING OF THE MEDIAL FEMORAL IMPLANT. THE REVISION SURGERY WAS PERFORMED.

  Patient problems: Pain

  MAUDE report 16563788 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTS WITH A WELL SIZED, ALIGNED, WELL FIXED TKA WITH AN APPROPRIATE JOINT LINE BUT COMPLAINS OF PAIN. UPON EXAM, SURGEON NOTES SOME MID FLEXION INSTABILITY. SURGEON MAKES ATTEMPTS POLY EXCHANGE BUT STILL THERE IS FLEXION-EXTENSION MISMATCH. COMPONENTS ARE REMOVED AND A FULL REVISION PROCEEDS UNEVENTFULLY. NO PATIENT HARM WAS NOTED. DOI: (B)(6) 2019. DOR: (B)(6) 2022. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 16091302 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD (B)(6) 2022. REVISION OPERATIVE NOTES (B)(6) 2022 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REVISION DUE TO CHRONIC INSTABILITY WITH LOOSE FEMORAL AND TIBIAL COMPONENTS. UPON ENTERING THE JOINT, CHRONIC INFLAMMATION AND SCARRING WERE ENCOUNTERED AND DEBRIDED. FEMORAL COMPONENT WAS NOTED TO BE LOOSE AT THE BONE TO CEMENT INTERFACE, A LARGE METAPHYSEAL BONE DEFECT. THE TIBIAL COMPONENT WAS NOTED TO BE LOOSE AT THE CEMENT TO IMPLANT INTERFACE. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON.

  Patient problems: Adhesion(s); Inflammation; Joint Laxity; Unspecified Tissue Injury

  MAUDE report 15583697 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FEMORAL COMPONENT REVISION WAS PERFORMED DUE TO LACK OF RANGE OF MOTION CAUSED BY ARTHROFIBROSIS. FEMUR WAS REMOVED AND DOWNSIZED TO A 5 FEMUR WITH CEMENTED STEM AND AUGMENTS. A 6MM CRS FB POLY WAS SELECTED AND IMPLANTED. SALES REP HAVE NO FURTHER INFORMATION. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 15502198 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A FEMORAL COMPONENT REVISION DUE TO FLEXION CONTRACTURE. FEMUR WAS REMOVED AND DOWNSIZED. IT WAS REPLACED WITH A CRS FEMUR AND CEMENTED STEM. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Contracture

  MAUDE report 15294262 ↗
• InjuryAug 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO HAVING KNEE ISSUES WITH BALANCE. UPON EVALUATION OF THE KNEE, THE MCL WAS QUITE LAX AND WAS UNABLE TO ADDRESS WITH CORRECTION. SURGEON ELECTED TO REVISE THE KNEE TO A SROM HINGE KNEE. THE CEMENT MANUFACTURER WAS NOT INDICATED. DOI: (B)(6) 2022, DOR: (B)(6) 2022, RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15147396 ↗
• InjuryFeb 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CLINICAL ADVERSE EVENT RECEIVED FOR DECREASED RANGE OF MOTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021. DATE OF EVENT (ONSET): (B)(6) 2022. (RIGHT KNEE) TREATMENT: MANIPULATION UNDER ANESTHESIA.

  Patient problems: Loss of Range of Motion

  MAUDE report 13567908 ↗