ATTUNE 1504-10-107Recalls & reported problems

Summary

The FDA's MAUDE database contains 158 adverse event reports that list this exact device (DI 10603295041641), received between Oct 18, 2017 and Jul 29, 2026 — classified as 147 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (31 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 158 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2026Migration

  It was reported that the femur is in extreme valgus.DOI: Unknown.DOR: (b)(6)2026.Affected side: Left Hip.

  Patient problems: Insufficient Information

  MAUDE report 50077230 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION- INFECTION DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: NO INFORMATION PROVIDED. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: (B)(6) 2026. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: WERE DEPUY SYNTHES COMPONENTS REMOVED: YES (FEMORAL, TIBIAL).

  Patient problems: Unspecified Infection

  MAUDE report 24560750 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. LEFT TOTAL KNEE ARTHROPLASTY WAS DONE. DOI: (B)(6) 2021. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24221453 ↗
• InjuryOct 15, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6) STUDY NO: (B)(6) CLINICAL ADVERSE EVENT RECEIVED FOR FAILURE OF LEFT TOTAL KNEE ARTHROPLASTY. LOOSENING OF TIBIAL AND FEMORAL COMPONENTS. MEDDRA CODE - 10021539 DEVICE RELATED: DEFINITELY RELATED PROCEDURE RELATED: POSSIBLY RELATED DATE OF EVENT: (B)(6) 2024 DATE OF IMPLANT: (B)(6) 2013 DATE OF REVISION: (B)(6) 2024 DEVICE LOCATION: LEFT TREATMENT/IMPACT: REQUIRES IN PATIENT HOSPITALIZATION, RESULTS IN A MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR FUNCTION, MEDICAL INTERVENTION/MODIFICATION, REVISION OF LEFT TOTAL KNEE ARTHROPLASTY, COMPONENTS REMOVED: FEMORAL COMPONENT, TIBIAL BASE, TIBIAL INSERT, AND PATELLAR COMPONENT (FOR PREVIOUSLY RESURFACED PATELLA).

  Patient problems: Insufficient Information

  MAUDE report 23294716 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS INFECTED WITH MERSA SO ALL OF HER PREVIOUS IMPLANTS WERE TAKEN OUT TO BE REPLACED WITH ANTIBIOTIC SPACERS. NO PATIENT CONSEQUENCES

  Patient problems: Unspecified Infection

  MAUDE report 23289986 ↗
• InjurySep 11, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF FEMUR AT CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23024849 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPLANTED DUE TO INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22689303 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AS A STAGE 1 KNEE REVISION. SURGEON TOOK OUT ALL COMPONENTS AND PUT IN AN ANTIBIOTIC SPACER TO RULE OUT INFECTION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22522482 ↗
• MalfunctionJul 10, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE FEMORAL COMPONENT WASN'T ABLE TO BE DELIVERED TO STERILE FIELD. IT WAS STUCK IN THE OUTER CONTAINER. AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22468965 ↗
• MalfunctionApr 29, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  ADDITIONAL INFORMATION WAS RECEIVED: A. WAS THERE ANY PATIENT HARM/CONSEQUENCE RELATED TO THE EVENT? NO PATIENT WAS HARMED. B. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? CASE WAS DELAYED. C. COULD YOU PLEASE PROVIDE VALID THE LOT NUMBER OF THE REPORTED PRODUCT? THE STICKER IS WITH THE FEMUR THAT WAS RETURNED BACK TO THE OFFICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21930036 ↗
• MalfunctionNov 18, 2024Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE STERILE IMPLANT WAS NOT ABLE TO BE DELIVERED TO STERILE FIELD. IT WAS STUCK IN OUTER BOX. DOE: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20711221 ↗
• MalfunctionSep 26, 2024Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE STERILE IMPLANT WAS NOT ABLE TO BE TAKEN OUT OF THE BOX BY OR PERSONNEL. IT WAS LIKE IT WAS STUCK INSIDE OUTER BOX. DOE: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20310504 ↗
• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CHRONIC DRAINAGE FROM KNEE AND SCHEDULED FOR IRRIGATION AND DEBRIDEMENT (I&D) WITH HARDWARE REMOVAL ON (B)(6) 2024. DOI: (B)(6) 2024. DOE: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 19992138 ↗
• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PLANNED INLAY REVISION OF PS-ATTUNE-KNEE-TEP LEFT SIDE AFTER ABOUT ONE YEAR OF IMPLANTATION BECAUSE PATIENT HAD ISSUES STRETCHING THE KNEE. INTRAOPERATIVELY THE PE-INLAY SHOWED STRANGE SCRATCHES. SURGEON DECIDED TO CHANGE COMPLETE KNEE-TEP TO A COMPETITOR PRODUCT.

  Patient problems: Loss of Range of Motion

  MAUDE report 19836932 ↗
• InjuryMay 1, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISE DUE TO AESEPTIC LOOSENING OF THE PATELLA, TIBIA AND FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. FULL ATTUNE CRS WAS RE-IMPLANTED, THERE WAS NO X-RAYS AVAILABLE AT THIS TIME, IMPLANTS NOT BEING RETURNED. DOI: (B)(6) 2019, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19219914 ↗
• InjuryApr 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS BEING REVISED DUE TO INFECTION. ALL HARDWARE FROM A PRIMARY TOTAL KNEE WAS REMOVED AND A CEMENT SPACER WAS PLACED IN THE PATIENT. DOI: UNKNOWN, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19192040 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? NO. WHAT IS SPECIFIC ALLEGATION AGAINST THE REPORTED PRODUCT? SUSPECTED INFECTION, NO WAY TO VERIFY.

  Patient problems: Unspecified Infection

  MAUDE report 19042812 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS PRESENTED WITH INFECTION AND INSTABILITY DUE TO LOOSENING OF THE PATELLA AND FEMORAL COMPONENTS AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. ALL IMPLANTS WERE REVISED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 18979964 ↗
• InjuryMar 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE PAIN AND STIFFNESS. SURGICAL DELAY UNKNOWN. ACTIVITY LEVEL - YES DOI: (B)(6) 2019 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 18815602 ↗
• InjuryFeb 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS PRESENTED AT HOSPITAL WITH INFECTED KNEE, 10 MONTHS POST TKA. PLAN TO I&D. PROBABLE TKA REMOVAL ON (B)(6) 2024. PLAN TO REMOVE. IT WAS UNKNOWN BOUT SURGICAL DELAY, DOI: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18766566 ↗
• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INSTABILITY AND NEEDED A REVISION. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18711105 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A POOR MOTION AND COMPLAINED OF PAIN AND INSTABILITY. A REVISION TKA WAS PERFORMED UNEVENTFULLY. A SIGNIFICANT POSTERIOR RELEASE WAS PERFORMED AND ADDITIONAL DISTAL FEMORAL RESECTION WAS NECESSARY TO GAIN EXTENSION. NO PATIENT HARM OCCURRED. NO DELAY WAS ENCOUNTERED. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

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

  MAUDE report 18337847 ↗
• InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL KNEE. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 18319467 ↗
• InjuryOct 6, 2023Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT WAS EXPERIENCING PAIN.

  Patient problems: Insufficient Information; Pain

  MAUDE report 17886025 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VOLUNTARY REPORT FROM HEALTH AUTHORITY.

  Patient problems: Pain

  MAUDE report 17583779 ↗