ATTUNE 1504-10-204Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 10603295041757), received between Jan 12, 2018 and Mar 6, 2026 — classified as 61 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 67 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED BILATERAL KNEE PAIN, PARTICULARLY IN THE RIGHT KNEE, FOLLOWING RIGHT KNEE ARTHROPLASTY. THE PAIN WAS CONSIDERED TO BE DUE TO PROSTHESIS DISCOMFORT OR EXCESSIVE SUTURE TENSION AFTER JOINT REPLACEMENT. THE STITCHES WERE INTERMITTENTLY REMOVED FROM THE WOUND FOR DRESSING CHANGE TO REDUCE THE WOUND TENSION. THE PATIENT WAS GIVEN IODOPHOR SOLUTION FOR DRESSING CHANGE. PATIENT IMPROVED SIGNIFICANTLY AFTER A FEW DAYS AND WAS DISCHARGED. PRODUCT NOT EXPLANTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: Discomfort; Pain

  MAUDE report 24533333 ↗
• InjuryFeb 2, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT RIGHT PATELLOFEMORAL ARTHRITIS REMOVAL FOR RIGHT PATELLOFEMORAL ARTHRITIS ON RIGHT KNEE WITH THE IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY ON (B)(6) 2026, THE PATIENT COMPLAINED OF PAIN IN THE RIGHT PATELLA AND A CLUNKING SOUND IN THE PATELLA WHEN FLEXED. ON (B)(6) 2026, THE SECOND SURGERY WAS PERFORMED. THE SOFT TISSUE INSIDE THE PATELLA WAS REMOVED. THE SURGERY WAS COMPLETED WITHOUT REVISION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 24241083 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLAINED OF PAIN IN KNEE. BONE SCAN INDICATED FEMORAL MAY BE LOSE. RIGHT FEM REVISION. FEM TOOK SAWS, AND POSTERING IN ORDER TO REMOVE. REVISION FEM WAS CEMENTED IN. THERE WAS NO SURGICAL DELAY. THERE WERE NO ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT. DOI: (B)(6) 2023, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24225501 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT NEEDED TO BE REVISED DUE TO GLOBAL INSTABILITY. SURGEON FELT IT BEST TO CONVERT TO A HINGED PROSTHESIS. DOI: ON (B)(6) 2022, DOR: ON (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22680706 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO AN ARTICULATING ANTIBIOTIC SPACER DUE TO INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22642022 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6) . CLINICAL ADVERSE EVENT RECEIVED FOR CLOSED DISPLACED COMMINUTED FRACTURE OF SHAFT OF RIGHT FEMUR DEVICE AND PROCEDURE(RELATEDNESS) DEVICE RELATED: POSSIBLY RELATED PROCEDURE RELATED: POSSIBLY RELATED.

  Patient problems: Limb Fracture

  MAUDE report 22037868 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PERIPROSTHETIC FEMUR FRACTURE OF R SIDE (STUDY SIDE) DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: POSSIBLY RELATED, PROCEDURE RELATED: POSSIBLY RELATED, DATE OF EVENT: 10-MAR-2022, DATE OF IMPLANT: (B)(6) 2014, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: HOSPITALIZATION, RESULTS IN A MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR FUNCTION, SURGICAL INTERVENTION NOT FOR THE STUDY KNEE (OPEN REDUCTION WITH INTERNAL FIXATION. KNEE IMPLANT WAS NOT REMOVED OR REVISED. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150410204, LOT NUMBER: 390187, COMPONENT TYPE: FEMORAL, DESCRIPTION: ATTUNE POST/STAB FEM RT, SZ 4 CEMENTED. CATALOG NUMBER: 150610004, LOT NUMBER: 3514793, COMPONENT TYPE: TIBIAL, DESCRIPTION: ATTUNE RP TIBIAL SZ 4, CEMENTED. CATALOG NUMBER: 151650407, LOT NUMBER: 3461897, COMPONENT TYPE: INSERT, DESCRIPTION: ATTUNE PS/RP INSERT SZ 4, 7MM. CATALOG NUMBER: 151820035, LOT NUMBER: 6106976, COMPONENT TYPE: PATELLAR, DESCRIPTION: ATTUNE MEDIAL DOME PAT, 35MM. CATALOG NUMBER: 61979001, LOT NUMBER: MJU094, COMPONENT TYPE: CE

  Patient problems: Limb Fracture

  MAUDE report 22035049 ↗
• MalfunctionMay 8, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT NO PRODUCT INFORMATION WAS ETCHED IN THE DEVICE. IT WAS ALSO REPORTED THAT DURING SURGERY, AFTER OPENED THE PACKINGS, IT WAS NOTED THAT THERE'S NO PRODUCT INFORMATION FROM LEFT/RIGHT, THERE IS NO IDENTIFICATION ON THIS DEVICE. NORMALLY THIS INFORMATION WILL BE ETCHED ON THE DEVICE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986913 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED TOTAL KNEE. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN , DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 21971747 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL A WEEK AFTER HER PRIMARY SURGERY AND BROKE HER DISTAL FEMUR ABOVE HER FEMORAL IMPLANT. DR. DECIDED TO REMOVE HER PRIMARY KNEE AND REPLACE WITH A DISTAL FEMORAL REPLACEMENT AND ATTUNE REVISION TIBIAL COMPONENT. NOTHING WAS MENTIONED ABOUT AN ISSUE WITH OUR IMPLANT AND TIME WAS NOT EXTENDED. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 21959612 ↗
• InjuryJan 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO A STIFF KNEE WITH LOW ROM AND THE IMPLANTS WERE WELL FIXED. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 21210129 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A KNEE REPLACEMENT AT ANOTHER HOSPITAL AND LACKED RANGE OF MOTION . SURGEON REMOVED THE FEMUR, CUT THE DISTAL FEMUR AND PUT IN ATTUNE POLY 4X8. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 20412933 ↗
• MalfunctionAug 22, 2024Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT WHILE PERFORMING RIGHT TOTAL KNEE REPLACEMENT SURGERY AT HOSPITAL. DURING THE SURGERY WHEN IMPLANTS BOX WAS OPEN: OUTER BOX WAS FINE AND IT WAS NOTICED THAT INSIDE STERILE CONTAINER WAS OPEN AND DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20039006 ↗
• MalfunctionApr 11, 2024Incomplete or Missing Packaging; Device Contaminated During Manufacture or Shipping; Incomplete or Missing Packaging; Device Contaminated During Manufacture or Shipping

  WHILE OPENING THE ORIGINAL IMPLANT (ATTUNE FEMORAL COMPONENT POSTERIOR STABILIZED ,SIZE 4 RIGHT SIDE FEMUR) ONLY ONE DISPLACED SHAPE OF IMPLANT INNER BOX WAS OBSERVED. TWO INNER BOX WILL BE PRESENT USUALLY. SURGEON WAS ON DOUBT, WHETHER ITS STERILE OR NOT .SO, HE DID NOT USE THIS IMPLANT AND KEPT ASIDE AND USED SAME SIZE OF ANOTHER IMPLANT. SURGERY WAS DELAYED 10 MINUTES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19087048 ↗
• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD UNI TO TOTAL KNEE REPLACEMENT. PATIENT HAS BEEN UNSTABLE. REVISED TO KNEE REVISION. THERE WAS NO SURGICAL DELAY. THERE WAS NO BROKEN INSTRUMENTS OR IMPLANTS. DOI: (B)(6) 2019. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18825671 ↗
• InjuryJan 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION IN THE JOINT THAT COULD NOT BE SOLVED WITH A WASHOUT. ATTUNE KNEE WAS REMOVED SO THAT AN ANTIBIOTIC SPACER COULD BE IMPLANTED TO FIGHT THE INFECTION. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18557858 ↗
• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON SAID THE PATIENT KNEE WAS INFECTED AND DECIDED TO REMOVE IMPLANTED COMPONENTS AND REPLACE WITH CEMENT SPACER. NO ONE REPORTED ANY PROBLEM WITH DEPUY IMPLANTS. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18011678 ↗
• InjurySep 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TKA REVISION FOR PAIN AND INFLAMMATION. RIGHT KNEE. CEMENT NOT FROM DEPUY. DOI: (B)(6) 2020. DOR: (B)(6) 2023. RIGHT KNEE. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? --> YES, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? --> YES, FACILITY NAME OF ORIGINAL IMPLANT --> CLINIQUE GÉNÉRALE BEAULIEU, WAS DEVICE EXPLANTED? --> TRUE, HARDWARE/EXPLANT REMOVAL DUE TO: --> KNEE PAIN AND INFLAMMATION, DID PATIENT REQUIRE REVISION SURGERY? --> TRUE, IF YES, DATE OF REVISION SURGERY. --> (B)(6) 2023, REASON FOR REVISION SURGERY. --> KNEE PAIN AND INFLAMMATION, IF NO, WAS THERE ANY ADDITIONAL MEDICAL INTERVENTION REQUIRED SUCH AS X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS?--> NO, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?--> KNEE PAIN AND INFLAMMATION, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> NO, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, IP-01831655 D

  Patient problems: Inflammation; Pain

  MAUDE report 17806829 ↗
• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT RETURNED TO SURGERY FOR KNEE INSTABILITY. THE FEMUR AND TIBIA WERE REMOVED AND AN ATTUNE REVISION RP TIBIA WAS PLACED WITH SROM-NOILES HINGE WAS PLACED. THERE WERE NO DEFICIENCIES, DELAYS OR BROKEN INSTRUMENTS. DOI:(B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17607411 ↗
• InjuryMay 9, 2023Migration; Migration

  PATIENT WAS REVISED DUE TO IMPLANTS SUBSIDED , BONE QUALITY NOT GOOD. WENT BACK IN WITH LONGER STEM . DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16897409 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ACUTE KIDNEY INJURY AND DEHYDRATION (HYPOVOLEMIA). EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. (RIGHT KNEE). TREATMENT: PRESCRIBED PANTOPRAZOLE & GIVEN IV HYDRATION.

  Patient problems: Dehydration; Renal Impairment

  MAUDE report 16832992 ↗
• InjuryApr 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PRIMARY SURGERY WAS PERFORMED VIA TKA FOR OA WITH THE IMPLANTS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2023, THE PATIENT WAS RUSHED TO THE HOSPITAL IN THE MORNING DUE TO DIZZINESS, SPEECH DISTURBANCE, AND DECREASED LEVEL OF CONSCIOUSNESS BECAUSE OF SUSPECTED SEPSIS DUE TO INFECTION. WITH VITALS BACK TO NORMAL, THE PATIENT WAS TRANSFERRED TO THIS FACILITY, WHERE A THOROUGH EXAMINATION WAS CONDUCTED AND INFECTION WAS CONFIRMED. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, TO REMOVE ALL THE IMPLANTS AND PLACE THE ANTIBIOTIC CEMENT MOLD. ALSO, DRAINS WERE PLACED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE INFECTION WAS CAUSED BY PUS THAT HAD ACCUMULATED IN THE TOE. HISTORY OF DIABETES MELLITUS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Dizziness; Sepsis; Unspecified Infection

  MAUDE report 16752517 ↗
• InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION AND LOOSENING OF THE TIBIAL COMPONENT AT THE UNKNOWN INTERFACE. DOI: (B)(6) 2017. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16732360 ↗
• InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16139384 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTED KNEE DUE TO LOOSENING OF FEMUR AND TIBIA AT BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 15636479 ↗