ATTUNE 1506-10-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 442 adverse event reports that list this exact device (DI 10603295042587), received between Jul 10, 2017 and Dec 4, 2025 — classified as 440 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (344 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 442 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO S TIBIA LOOSENING AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23716293 ↗
• InjuryNov 12, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT A TKA SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE SURGERY ON (B)(6) 2025, IT WAS CONFIRMED THAT FOLLOWING A TIBIAL FRACTURE CAUSED BY A FALL, LOOSENING OF THE TIBIAL IMPLANT OCCURRED. THE REVISION SURGERY IS SCHEDULED ON (B)(6) 2025. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 23534302 ↗
• InjuryJul 21, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE ATTUNE PRIMARY KNEE REQUIRED REVISION DUE TO LOOSENING AND PAIN.

  Patient problems: Pain

  MAUDE report 22556302 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REMOVAL OF FEMUR, TIBIA AND INSERT DUE TO PAIN. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21975506 ↗
• InjuryFeb 18, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT HAD A VERY LARGE LEG DUE TO LYMPH OEDEMA AND WAS IMPLANTED WITH ATTUNE PS/RP. PATIENT UNDERWENT REVISION SURGERY DUE TO LOOSENING OF ALL COMPONENTS. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Swelling/ Edema

  MAUDE report 21403650 ↗
• InjuryJan 24, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH THREE KNEE REPLACEMENT DEVICE BY THREE MANUFACTURERS AND ALL THREE DEVICES FAILED. SO FAR PATIENT HAD TWO REVISIONS AND AWAITING A THIRD ONE. ON (B)(6) 2016, THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY WITH DEPUY PRODUCTS. ON (B)(6) 2023, THE PATIENT HAD A REVISION OF THE RIGHT KNEE TO ADDRESS PAIN, LOOSE KNEE, "NEVER FELT RIGHT". ALL DEPUY COMPONENTS WERE REMOVED AND COMPETITOR PRODUCTS WERE PLACED AT THAT TIME. IT WAS FURTHER REPORTED THAT THE PATIENT'S LEFT KNEE WAS IMPLANTED WITH COMPETITOR PRODUCTS.

  Patient problems: Joint Laxity; Pain

  MAUDE report 21232123 ↗
• InjuryJan 21, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT PRIMARY IMPLANTS TOOK OUT. THERE WAS LOOSENING OF TIBIA AT CEMENT TO IMPLANT INTERFACE. THE CEMENT MANUFACTURER WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Insufficient Information

  MAUDE report 21199592 ↗
• InjuryDec 26, 2024Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. IT WAS ALSO REPORTED THAT THE GEN I TIBIAL TRAY WAS BEGINNING TO SUBSIDE. DOI: (B)(6) 2017 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21020663 ↗
• InjuryDec 11, 2024Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  IT WAS REPORTED THAT TIBIAL REVISION WAS PERFORMED DUE TO SINKING OF ORIGINAL IMPLANT. DOI: (B)(6) 2017. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20905854 ↗
• InjuryOct 30, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO KNEE PAIN. X-RAY SHOW THERE WAS A LOOSENING IN TIBIAL COMPONENT AT CEMENT TO IMPLANT INTERFACE. DOI: (B)(6) 2015. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 20567791 ↗
• InjuryOct 8, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2024, DUE TO FEMORAL AND TIBIAL LOOSENING.

  Patient problems: Insufficient Information

  MAUDE report 20400638 ↗
• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR: SEPTIC SHOCK. DEVICE AND PROCEDURE (RELATEDNESS): NO INFORMATION PROVIDED. DATE OF EVENT: 04-NOV-2021, DATE OF IMPLANT: (B)(6) 2014, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: RIGHT KNEE. TREATMENT/IMPACT: REQUIRES INPATIENT HOSPITALIZATION/RESOLVED WITH RESIDUAL EFFECTS.

  Patient problems: Septic Shock

  MAUDE report 20124758 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL KNEE. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2016. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 19938202 ↗
• 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: LOOSENING.

  Patient problems: Insufficient Information

  MAUDE report 18979622 ↗
• InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TKJR DONE SIZE 5 FEMUR, SIZE 4 TIBIA, 5MM INSERT, 32 PATELLA. RADIOLUCENT LINES EVIDENT ON X-RAY, PATIENT EXPERIENCING PAIN HENCE THE DECISION TO REVISE ALL IMPLANTS. ONCE EXPOSURE WAS GAINED, THE IMPLANTS WERE REMOVED USING OSTEOTOMES, NOTED THAT THE IMPLANTS WERE NOT LOOSE. HOWEVER THE DECISION HAD BEEN MADE TO REMOVE AT THIS TIME DUE TO PAIN THAT THE PATIENT HAD BEEN EXPERIENCING AND ALSO THE IMPLANTS HAD BEEN COMPROMISED IN TERMS OF CEMENT MANTLE. ATTUNE REVISION IMPLANTED WITH SIZE 4 TIBIA AND 45MM PARTIAL COATED SLEEVE WITH 12X60 PRESSFIT STEM. BONE LOSS ON THE FEMUR WAS MINIMAL SO A SIZE 5 FEMUR WITH A 14X60 PRESSFIT STEM WAS PLACED. THE KNEE WAS BALANCED WITH A 10MM CRS INSERT THE 32MM PATELLA IMPLANT REMAINED INSITU.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 18947210 ↗
• InjuryMar 15, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO GROSSLY LOOSE IMPLANT. IT LED TO OSTEOLYSIS OF POLY AND PATELLA/ FEMORAL LOOSENING AT AN UNKNOWN INTERFACE. THERE WAS CHAIN OF CUSTODY IMPLANT. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18913152 ↗
• InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FLEXION EXTENSION MISMATCH. SURGEON STATES IMPLANTED OVER 10 YEARS AGO. LOOSENING WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18902628 ↗
• InjuryJan 9, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT HAD A LOOSENING OF THE TIBIA AT CEMENT TO IMPLANT INTERFACE. THE ATTUNE KNEE WAS EXPLANTED AND REVISED THAT WAS INITIALLY IMPLANTED ON (B)(6) 2015. THE CEMENT MANUFACTURER WAS UNKNOWN. DOI: (B)(6) 2015, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18475852 ↗
• InjuryNov 21, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION RECEIVED. A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO DELAY. B. WAS THERE ANY PATIENT HARM RELEVANT TO THIS EVENT? IF YES, PLEASE KINDLY PROVIDE DETAILS. NO HARM.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18183638 ↗
• InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF AN ATTUNE. RIGHT SIDE. PRIMARY WAS DONE IN 2018. THEY HAD A DEBRIDEMENT AND MUA IN 2019. REVISION OF THE FEMORAL COMPONENT AND INSERT IN 2020. THEY HAVE HAD ONGOING ISSUES SINCE FIRST SURGERY IN 2018. THIS REVISION WAS DUE TO STIFFNESS AND PAIN.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 18021835 ↗
• InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED. A. WHAT IS THE EVENT DATE? I¿M NOT SURE OF THE EXACT DATE SORRY. PATIENT NOTES ONLY HAD THE YEAR. B. CAN YOU PLEASE CONFIRM THE MANUFACTURER OF THE CEMENT PRODUCT? IF DEPUY, PLEASE PROVIDE THE PRODUCT CODE AND LOT NO. OF THE REPORTED PRODUCT. THIS SURGEON CURRENTLY USES DEPUY CEMENT, BUT I CAN¿T CONFIRM IF IT WAS USED AT THIS TIME. C. CAN YOU CONFIRM THE PRIMARY SURGERY DATE OR THE ORIGINAL IMPLANTATION DATE? SORRY PATIENT NOTES ONLY SHOWED THE YEAR, NOT THE EXACT DATE. IMPLANT SCREENSHOTS WHICH I PROVIDED ON A PREVIOUS EMAIL WILL BE WITHIN A DAY OR SO OF 11 OCTOBER 2018 D. WHAT WAS THE REASON FOR DEBRIDEMENT AND MUA IN 2019? WAS THERE ANY ADVERSE CONSEQUENCES/SYMPTOMS THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? REASON FOR MUA AND DEBRIDEMENT WAS DUE TO STIFFNESS AND PAIN. NO ADVERSE CONSEQUENCES NOTED.

  Patient problems: Insufficient Information; Muscular Rigidity; Pain

  MAUDE report 18021574 ↗
• InjuryOct 16, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMUR AND TIBIA OF THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. IT WAS REVISED TO A CRS RP CONSTRUCT. DOI: (B)(6), 2018, DOR: (B)(6), 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17944840 ↗
• InjuryOct 9, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED AS THE TIBIA WAS LOOSE. THE LOOSENING INTERFACE AND CEMENT MANUFACTURER WERE UNKNOWN. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2018, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17895212 ↗
• InjurySep 14, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2017, PATIENT UNDERWENT TOTAL KNEE JOINT REPLACEMENT USING ATTUNE KNEE SYSTEM DUE TO BONE ON BONE ARTHRITIS IN BOTH KNEES. AFTER 4 AND A HALF YEARS, PATIENT WAS EXPERIENCING SEVERE AND PERSISTENT PAIN, DISCOMFORT, SWELLING, INSTABILITY AND DIFFICULTY AMBULATING. PATIENT UNDERWENT REVISION ON (B)(6) 2023. DURING SURGERY, IT WAS OBSERVED THAT THE TIBIAL BASE CAME FREE FROM THE TIBIA WITH LITTLE OR NO FORCE, CEMENT ALSO DID NOT BOND OR ADHERE TO THE TIBIAL BASE. DOI: (B)(6) 2017. DOR: (B)(6) 2023. LEFT KNEE.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Joint Laxity; Loss of Range of Motion; Muscular Rigidity; Pain; Swelling/ Edema

  MAUDE report 17749785 ↗
• InjurySep 14, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2017, PATIENT UNDERWENT TOTAL KNEE JOINT REPLACEMENT USING ATTUNE KNEE SYSTEM DUE TO BONE ON BONE ARTHRITIS IN BOTH KNEES. AFTER 4 AND A HALF YEARS, PATIENT WAS EXPERIENCING SEVERE AND PERSISTENT PAIN, DISCOMFORT, SWELLING, INSTABILITY AND DIFFICULTY AMBULATING. PATIENT UNDERWENT REVISION ON (B)(6) 2023. DURING SURGERY, IT WAS OBSERVED THAT THE TIBIAL BASE CAME FREE FROM THE TIBIA WITH LITTLE OR NO FORCE, CEMENT ALSO DID NOT BOND OR ADHERE TO THE TIBIAL BASE. DOI: (B)(6) 2017. DOR: (B)(6) 2023. RIGHT KNEE. PATIENT IS BILATERAL, PLEASE SEE (B)(4) FOR THE LEFT KNEE.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 17749443 ↗