ATTUNE 1504-10-209Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10603295041801), received between Jun 27, 2017 and Sep 30, 2026 — classified as 42 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (10 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 42 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Age at time of surgery: 72 years.Subject ID: (b)(6).Study No: OASIS PROD.Clinical Adverse Event received for Revision: Infection.Device and procedure (relatedness).Device related: No information provided.Procedure related: No information provided.Date of Event: (b)(6) 2026.Date of Implant: (b)(6) 2026.Date of Revision: (b)(6) 2026.Device Location: Right Knee.Treatment/Impact: Were DePuy Synthes components removed: Yes (Femoral and Insert).DePuy Synthes Products Used:Catalog Number: 150410209,Lot Number: 4281082,Component Type: FEMORAL,Description: ATTUNE KNEE SYSTEM FEMORAL POSTERIOR STABILIZED SIZE 9 RIGHT CEMENTED.Catalog Number: 151650916,Lot Number: 4765786,Component Type: INSERT,Description: ATTUNE KNEE SYSTEM TIBIAL INSERT ROTATING PLATFORM POSTERIOR STABILIZED SIZE 9 16mm AOX.

  Patient problems: Unspecified Infection

  MAUDE report 50950675 ↗
• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that revision of RT knee for infection: 9PS Femur, 9x5mm PS insert, 9RP Tibia.Affected Side: Right Knee.

  Patient problems: Unspecified Infection

  MAUDE report 50299876 ↗
• InjuryAug 12, 2026Loss of or Failure to Bond

  It was reported that patient was revised for loosening of femur. Loosening interface was marked as cement to implant. Cement manufacturer was DePuy Synthes.DOI-(b)(6) 2022.DOR-(b)(6) 2026.Affected side-Right knee.

  Patient problems: Insufficient Information

  MAUDE report 50224044 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25233934 ↗
• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD SEPTIC REVISION IN RIGHT KNEE. DOI- (B)(6) 2025. DOR- (B)(6) 2025. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 23721149 ↗
• 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 21170961 ↗
• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: HOSPITALIZATION (INITIAL OR PROLONGED): YES, NO. REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE: NO, YES.

  Patient problems: Abscess

  MAUDE report 20831457 ↗
• InjuryOct 10, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT HAD A PREVIOUS RIGHT TOTAL KNEE DONE BY THE DOCTOR. THE SURGERY DATE IS UNKNOWN, BUT WAS DONE WITH AN ATTUNE RPPS KNEE. THE FEMUR COMPONENT WAS LOOSE AT UNKNOWN INTERFACE, CEMENT HAD DEBONED FROM THE BONE, AND THE PATIENT BROUGHT IN FOR REVISION. ALL COMPONENTS WERE REMOVED EXCEPT THE PATELLA. ATTUNE REVISION COMPONENTS WERE IMPLANTED. THERE WAS NO DELAY IN SURGERY TIME. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20417957 ↗
• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STAGE 1 REVISION BEING PERFORMED DUE TO INFECTION. ALL IMPLANTS WERE REMOVED SUCCESSFULLY. NO DELAY. NO OTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2020. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19268443 ↗
• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INSTABILITY. FLEXION/EXTENSION MISMATCH. FEMUR AND POLY WERE EXPLANTED. CRS FEMUR, AUGS, STEM, AND THICKER POLY WERE IMPLANTED. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2022; DOR- (B)(6) 2024; AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18948906 ↗
• InjuryJan 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD FEMUR REVISION DUE TO STIFFNESS. DOI: UNKNOWN, DOR: ON (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 18579270 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE. ALL IMPLANTS WERE REMOVED AND A CEMENT SPACER WAS PLACED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE. THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 17395651 ↗
• InjuryMar 22, 2023Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT THE PATIENT HAD TKA ON (B)(6) 2023. HE WAS ADMITTED TO THE HOSPITAL FOR SWELLING AND A LEFT KNEE INFECTION. DURING THE WORK UP IT WAS NOTED ON THE X-RAY THAT THERE WAS A RIGHT KNEE FEMORAL IMPLANT ON THE LEFT FEMUR. THE PATIENT WAS BROUGHT TO SURGERY AND THE FEMUR WAS REMOVED AND A ATTUNE REVISION IMPLANT WAS PLACED. THE KNEE WAS DEBRIDED AND A SINGLE STAGE RE IMPLANT WAS DONE. THERE WAS NO LOOSENING, OR BROKEN INSTRUMENTS. THE CEMENT MANUFACTURER WAS UNKNOWN. NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 16591457 ↗
• InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR STABILITY ISSUES. THE CEMENT MANUFACTURER WAS UNKNOWN. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16184925 ↗
• InjuryJul 18, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION COMPLETED DUE TO AN INFECTION AND LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS AT THE CEMENT TO IMPLANT INTERFACE. THE FEMUR, TIBIA, AND THE POLY WERE REMOVED. DEPUY CEMENT WAS USED. NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2016. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15041002 ↗
• InjuryApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  1. PLEASE CLARIFY, WHAT WERE THE PRODUCTS REMOVED DUE TO INFECTION? BASED ON THE IMPACTED PRODUCTS REPORTED, ONLY THE PRODUCT RETURN STATUS OF THE TIBIAL INSERT WAS DISCARDED. 2. CAN YOU CONFIRM THE PRIMARY SURGERY DATE OR THE ORIGINAL IMPLANTATION DATE? 3. WAS THERE ANY SUGGESTION BY ANYONE INDICATING THAT THERE WAS OR MAY BE DEFICIENCY WITH THE PRODUCT(S). IF YES, PLEASE PROVIDE DETAILS. 4. WAS THE CEMENT PRODUCT MANUFACTURED BY DEPUY? IF YES, PLEASE PROVIDE THE PART AND LOT NUMBERS AND QUANTITY OF THE CEMENT. 5. CAN YOU PLEASE PROVIDE THE LOT NUMBER FOR THE REPORTED PRODUCTS (ATTUNE PS FEM RT SZ 9 CEM) AND (ATTUNE MEDIAL DOME PAT 41MM)? 6. PATIENT DEMOGRAPHICS & COMORBIDITIES. 7. RADIOGRAPHS/X-RAY FILMS AND OP NOTES IF AVAILABLE. RESPONSE: I HAVE PROVIDED ALL THE INFORMATION AVAILABLE. THE ONLY IMPLANT REVISED WAS THE BEARING AS IT IS A WASHOUT OR DAIR PROCEDURE FOR INFECTION AS REPORTED. DAIR IS DEBRIDEMENT, ANTIBIOTICS, IMPLANT RETENTION, A PROCEDURE FOR INFECTION WHILE RETAINING THE PROTHESIS. IT IS A COMMON ANACRONYM FROM THE PAST FIVE YEARS. THE IMPLANTS WERE MARKED UNAVAILABLE IMPLANTED WHICH WAS FOR ALL EXCEPT THE BEARING WHICH WAS DISCARDED TO ALLOW THOROUGH IRRIGATION O

  Patient problems: Unspecified Infection

  MAUDE report 14043770 ↗
• InjuryFeb 9, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  CLINICAL NOTIFICATION RECEIVED FOR REVISION TO ADDRESS LOOSENING OF AN UNKNOWN. COMPONENT AT AN UNKNOWN INTERFACE. DATE OF IMPLANTATION: (B)(6) 2014, DATE OF REVISION: (B)(6) 2021, (RIGHT KNEE). . TREATMENT: REVISION OF ALL COMPONENTS.

  Patient problems: Osteolysis; Pain; Swelling/ Edema

  MAUDE report 13496916 ↗
• InjuryJan 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTED KNEE. SURGEON CONDUCTED A STAGED REVISION AND PULLED ALL IMPLANTS. DOI: (B)(6) 2019, DOE: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13309008 ↗
• InjuryAug 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2015: PATIENT UNDERWENT A RIGHT TKA DUE TO DJD. PATELLA WAS RESURFACED AND DEPUY CEMENT WAS USED. NO COMPLICATIONS NOTED. (B)(6) 2019: PATIENT UNDERWENT A RIGHT TKA REVISION DUE TO ASEPTIC LOOSENING AND INSTABILITY. INTRAOPERATIVE FINDINGS INCLUDED - SWELLING/EFFUSION, MEDIAL LAXITY, FIBROUS SCARRING AND ADHESIONS, AND BLOOD TINGED SYNOVIAL FLUID (SYNOVITIS) THAT WAS ENCROACHING ON THE JOINT CAUSING IMPINGEMENT. THERE WAS A FRAGMENTATION OF THE CEMENT ALONG PERIPHERAL MARGINS OF THE FEMORAL COMPONENT. FEMORAL COMPONENT WAS NOTED TO BE WELL FIXED, BUT SLIGHTLY OVERSIZED. THE TIBIAL INSERT SHOWED WEARING AND PITTING ON MEDIAL SIDE. THE PATELLA HAD SOME FLAT SPOT WITH OSTEOLYTIC CHANGES. THE TIBIAL COMPONENT WAS GROSSLY LOOSE WITH SEPARATION OF THE COMPONENT FROM THE CEMENT. MEDIAL TIBIAL BONE LOSS. ALL DEPUY IMPLANTS WERE REMOVED AND REPLACED WITH COMPETITOR IMPLANTS. (B)(6) 2020: PATIENT UNDERWENT AN INSERT EXCHANGED DUE TO INFECTION - COMPETITOR PRODUCTS INVOLVED. DOI: (B)(6) 2015. DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: Adhesion(s); Joint Laxity; Swelling/ Edema; Synovitis

  MAUDE report 12319490 ↗
• InjuryJul 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO RIGHT TOTAL KNEE THAT IS INFECTED. THE SURGEON REMOVED THE COMPONENTS AND IMPLANTED TEMPORARY PARTS. ALL COMPONENTS WERE WELL FIXED. DOI: (B)(6) 2019, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12200689 ↗
• InjuryJun 29, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS GROSS LOOSENING OF BOTH FEMUR AND TRAY AT THE BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACES. POSITIVE INFECTION PRESENT SO ALL IMPLANTS EXPLANTED AND ANTIBIOTIC SPACER WAS IMPLANTED. UNKNOWN BONE CEMENT WAS USED. DOI: UNKNOWN. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12089667 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS FLEXION /EXTENSION MISMATCH AND INSTABILITY. DOI: (B)(6) 2019, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12088661 ↗
• InjuryApr 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THEY RESECTED THE INFECTED KNEE DOI: (B)(6) 2016 DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11713650 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS ACUTE SWELLING. SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT WITH REMOVAL OF COMPONENTS AND PLACEMENT OF ANTIBIOTIC SPACER WITH ATTUNE PS FEMUR AND RP INSERT. THERE WAS NO INDICATION OF GROSS INFECTION. THE KNEE WAS FILLED WITH OLD BLOOD. ALL COMPONENTS WERE REMOVED EXCEPT THE PATELLA. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2021. DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Swelling/ Edema

  MAUDE report 11516741 ↗
• InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. EXPLANT OF IMPLANTS AND INSERTED ANTIBIOTIC SPACER. NO ADDITIONAL INFORMATION AVAILABLE. NO SURGICAL DELAY. DOI: (B)(6) 2020; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 10959826 ↗