ATTUNE 1504-40-108Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10603295042211), received between Sep 5, 2018 and Jul 13, 2026 — classified as 32 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED AS THE THEY HAD PAIN, STIFFNESS, AND EFFUSION FROM ORIGINAL SURGERY DATE. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscular Rigidity; Pain; Swelling/ Edema

  MAUDE report 25796461 ↗
• InjuryFeb 24, 2026Loss of or Failure to Bond

  SUBJECT ID: (B)(6) STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ ASEPTIC LOOSENING. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: 26 JAN 2026. DATE OF IMPLANT: (B)(6) 2008. DATE OF REVISION: (B)(6) 2026. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: KNEE REPLACEMENT; WERE DEPUY SYNTHES COMPONENTS REMOVED? YES; COMPONENTS REMOVED (FEMORAL, INSERT, TIBIAL. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150440108, LOT NUMBER: MC4462, COMPONENT TYPE: FEMORAL, DESCRIPTION: ATTUNE REVISION CRS FEMORAL SIZE 8 LEFT CEMENTED. CATALOG NUMBER: 150660006, LOT NUMBER: 4986915, COMPONENT TYPE: TIBIAL, DESCRIPTION: ATTUNE REVISION TIBIAL BASE ROTATING PLATFORM SIZE 6 CEMENTED. CATALOG NUMBER: 151710810, LOT NUMBER: 9927060, COMPONENT TYPE: INSERT, DESCRIPTION: ATTUNE REVISION CRS ROTATING PLATFORM INSERT SIZE 8 10MM. CATALOG NUMBER: 151214050, LOT NUMBER: D25093258, COMPONENT TYPE: STEM, DESCRIPTION: ATTUNE REVISION CEMENTED STEM 14 MM X 50 MM. CATALOG NUMBER: 545050501, LOT NUMBER: 4989849, COMPONENT TYPE: CEMENT, DESCRIPTION: SMARTSET CEMENT WITH GENTAMICIN 40G. CATALOG NUMBER: 151111203, L

  Patient problems: Insufficient Information

  MAUDE report 24430679 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO DISTAL FEMORAL FRACTURE. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Limb Fracture

  MAUDE report 22967135 ↗
• MalfunctionMay 5, 2025Improper or Incorrect Procedure or Method; Device Damaged Prior to Use; Improper or Incorrect Procedure or Method; Device Damaged Prior to Use

  IT WAS REPORTED THAT UPON OPENING OF THE CRS FEMUR IMPLANT, THERE WAS A SMALL SCUFF ON THE MEDIAL CONDYLE. S WET LAP WAS USED TO TRY AND RUB OFF THE MARK BUT IT DID NOT COME OFF. THERE WAS NO ADVERSE EVENT. IT DID NOT HAPPEN DURING THE SURGERY. THERE WAS NO DELAY IN SURGERY. SURGEON DID IMPLANT THE FEMORAL COMPONENT. AFFECTED AREA: LEFT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21963221 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE EMERGENCY ROOM IN (B)(6) WITH BILATERAL INFECTED KNEES FROM AN ACUTE INFECTION IN THE PATIENTS BLOOD. IT AFFECTED BOTH THE KNEES WHICH HAD REV IMPLANTS IN AND BOTH THE SHOULDERS WHICH HAD NO IMPLANTS. PATIENT WAS WASHED OUT AND IMPLANT EXCHANGES TOOK PLACE ON 2 SEPARATE OCCASIONS AT A DIFFERENT FACILITY. DERS WERE SUBMITTED. PATIENT CAME INTO CLINIC FOR FOLLOW UP ON (B)(6) 2025 AND BOTH KNEES APPEARED TO STILL BE INFECTED. CULTURES SHOWED A SENSITIVE STREP. SURGEON ADMITTED THE PATIENT AND BILATERAL KNEE REVISIONS WERE PERFORMED IN A ONE STAGE FASHION TO INCLUDE THOROUGH IRRIGATION AND DEBRIDEMENT AND PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. THERE WAS NO DELAY NOR PATIENT HARM NOTED. NO ALLEGATIONS WERE MADE AGAINST ANY COMPONENT AS THIS WAS FROM AN ORGANISM IN PATIENT BLOOD THAT AFFECTED MULTIPLE JOINTS IN PATIENT'S BODY. DATE OF IMPLANTATIONS: RIGHT REVISION KNEE WAS (B)(6) 2016. LEFT REVISION KNEE WAS (B)(6) 2023. ON (B)(6) 2025, AN I&D AND INSERT EXCHANGE TOOK PLACE FOR THE LEFT KNEE FOR HEMATOMAS, AND POSSIBLE INFECTION (NOT CONFIRMED AT THAT TIME) AT (B)(6). CAPTURED IN (B)(4). AT THE SAME TIME, ON (B)(6) 2025, AN I&D AND INS

  Patient problems: Unspecified Infection

  MAUDE report 21884372 ↗
• InjuryOct 21, 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 UNSTABLE AND PAINFUL KNEE. DOI: (B)(6) 2024. DOR: (B)(6) 2024 . AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 20494501 ↗
• InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS HAD MULTIPLE SURGERIES TO TRY AND FIGHT A RECURRING INFECTION. THIS PATIENT HAD REVISION COMPONENTS PLACED (B)(6) 2023. THE INFECTION RETURNED, SO ALL COMPONENTS WERE TAKEN OUT AND AN ANTIBIOTIC CEMENT SPACER WAS PLACED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20492419 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED LEFT KNEE. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20398685 ↗
• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6), STUDY: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION LEFT KNEE EVENT IS SERIOUS AND IS CONSIDERED SEVERE EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): 07/03/2020. (LEFT KNEE). TREATMENT: SURGICAL IRRIGATION & DEBRIDEMENT, WITH REVISION OF TIBIAL INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 20074544 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION LEFT KNEE (ONGOING). EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF REVISION: (B)(6) 2020 (I&D WITH TIBIAL INSERT EXCHANGE). DATE OF EVENT (ONSET): 09/08/2020. (LEFT KNEE). TREATMENT: ASPIRATION AND DRAINAGE.

  Patient problems: Unspecified Infection

  MAUDE report 20031016 ↗
• InjuryJul 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION OF FEMORAL COMPONENTS OF ATTUNE REVISION POST DISLOCATION TO SROM HINGE.

  Patient problems: Joint Dislocation

  MAUDE report 19666559 ↗
• InjuryDec 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE FEMUR WAS DISLOCATED AT ONE TIME BUT HAD BEEN REDUCED AT THE TIME OF THE PROCEDURE. NOTHING LOOKED OUT OF THE ORDINARY.

  Patient problems: Joint Dislocation

  MAUDE report 18357873 ↗
• InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE STIFFNESS. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2018. DATE OF EVENT: (B)(6) 2021. (LEFT KNEE). TREATMENT: PHYSICAL THERAPY.

  Patient problems: Muscular Rigidity

  MAUDE report 17773083 ↗
• InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO CHRONIC INFECTION. SURGICAL DELAY UNKNOWN. DOI: (B)(6), DOR: (B)(6), AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16732434 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION #1: (B)(6) 2022. DATE OF REVISION #2: (B)(6) 2022. (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, TIBIAL, AND INSERT WERE REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 16213888 ↗
• InjuryApr 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR MANIPULATION UNDER ANAESTHETIC (MUA) TO ADDRESS STIFFNESS. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE . EVENT IS POSSIBLY RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DOI: (B)(6) 2019 (REVISION SURGERY, ALL PRODUCTS), DOE: (B)(6) 2019 (LEFT KNEE).

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 14111144 ↗
• InjuryDec 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR KNEE STIFFNESS (ONGOING). EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018, DATE OF EVENT (ONSET): (B)(6) 2019, (LEFT KNEE). TREATMENT: KNEE MANIPULATION UNDER ANESTHESIA.

  Patient problems: Muscular Rigidity

  MAUDE report 12975414 ↗
• InjuryNov 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT HAS A LONG HISTORY OF LT TKA WITH EXPLANT FOR INFECTION. INITIAL DOS (B)(6) 2020; POLY SWAP (B)(6) 2020; POLY SWAP (B)(6) 2020; POLY SWAP (B)(6) 2020; EXPLANT LEFT TKA WITH ANTIBIOTIC SPACER (B)(6) 2020; ATTUNE LEFT TKA REPLANT (B)(6) 2020; RE-INFECTED WITH EXPLANT AND SPACER 10/15/2021 WITH ALL HARDWARE REMOVED. THIS COMPLAINT IS FOR THE 6TH REVISION. DOI: (B)(6) 2020; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12737068 ↗
• InjuryNov 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HOLD SMP 11/2IT WAS REPORTED PATIENT HAS A LONG HISTORY OF LT TKA WITH EXPLANT FOR INFECTION. INITIAL DOS (B)(6) 2020; POLY SWAP (B)(6) 2020; POLY SWAP (B)(6) 2020; POLY SWAP (B)(6) 2020; EXPLANT LEFT TKA WITH ANTIBIOTIC SPACER (B)(6) 2020; ATTUNE LEFT TKA REPLANT (B)(6) 2020; RE-INFECTED WITH EXPLANT AND SPACER (B)(6) 2021 WITH ALL HARDWARE REMOVED. THIS COMPLAINT IS FOR THE 6TH REVISION. DOI: (B)(6) 2020, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12736960 ↗
• InjuryOct 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED INDICATED THAT THE PRIMARY OPERATIVE NOTES AND THE FIRST REVISION PROCEDURE NOTES WERE NOT PROVIDED WITHIN THIS SET OF MEDICAL RECORDS. IT IS UNKNOWN, AT THIS TIME, WHAT THE MANUFACTURER OF THE PRIMARY IMPLANTS OR FIRST REVISION SURGERY WERE. UNKNOWN IF DEPUY ¿ DATES OF PRIMARY AND FIRST REVISION SURGERIES ALSO NOT PROVIDED. REVISION OPERATIVE NOTES (B)(6) 2019 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION DUE TO INFECTION. IT IS UNKNOWN IF DEPUY PRODUCTS WERE IMPLANTED AT THIS SURGERY. RE-IMPLANTATION OPERATIVE NOTES (B)(6) 2019 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE RE-IMPLANTATION DUE TO INFECTION MARKERS WERE SATISFACTORY FOR RE-IMPLANTATION. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. REVISION OPERATIVE NOTES (B)(6) 2021 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION DUE TO INFECTION. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. (B)(4). REVISION OPERATIVE NOTES (B)(6) 2021 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION DUE TO PAIN, SWELLING AND HEMATOGENOUS SPREAD OF INFECTION. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURG

  Patient problems: Unspecified Infection

  MAUDE report 12705716 ↗
• MalfunctionSep 22, 2021Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE WHITE OVERLAPPING TAB ON THE INNER PACKAGING HAD BEEN SEALED THROUGH THE OUTER WHITE COVERING, THEREBY COMPROMISING THE STERILE PACKAGING. THIS WOULD NOT ALLOW THE INNER PACKAGING TO BE REMOVED BY THE STERILE NURSE. THE INNER WHITE COVER WAS PEELED BACK WITH THE INNER PACKAGING STILL WITHIN THE OUTER PACKAGING AS THIS WAS THE ONLY WAY TO REMOVE THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12514008 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPASS CASE (B)(4) REPORT: THE PATIENT WAS REVISED DUE TO INFECTION. EVERYTHING WAS REMOVED AND STAGE ONE SPACER IMPLANTED. NO LOOSENING AND SURGICAL DELAY NOTED. DOI: (B)(6) 2019, DOR: (B)(6) 2019, LEFT KNEE.

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

  MAUDE report 12438720 ↗
• MalfunctionSep 8, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE SEAL OF INNER PACKAGE WAS QUESTIONED BY DOCTOR AND WAS NOT USED FOR FEAR PF STERILITY ISSUE. NO SURGICAL DELAY. DOE: (B)(6) 2021, LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12438323 ↗
• InjuryApr 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LOW BACK PAIN EVENT IS SERIOUS AND IS CONSIDERED MODERATE THERE IS A REMOTE POSSIBILITY THAT THE ADVERSE EVENT IS RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018 DATE OF EVENT (ONSET): (B)(6) 2019 (LEFT KNEE). TREATMENT: RADIATION.

  Patient problems: Pain

  MAUDE report 11744506 ↗
• InjuryJan 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS MULTIPLE INFECTIONS AT THE UNKNOWN CAUSES. DOI: (B)(6) 2019; (B)(6) 2020 (POLY EXCHANGE DUE TO INSTABILITY CAPTURED IN (B)(4)), DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 11171605 ↗