ATTUNE 1504-01-107Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295041368), received between Mar 18, 2021 and Sep 28, 2026 — classified as 20 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (2 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revised due to pain. No loosening, nothing further to report.Affected Side: Left Knee.

  Patient problems: Pain

  MAUDE report 50913594 ↗
• InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE REPORTED DEVICE WAS EXPLANTED FOR INFECTION, ABX SPACER PLACED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25606520 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24413665 ↗
• InjuryJan 8, 2026Osseointegration Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ ASEPTIC LOOSENING. TREATMENT/IMPACT: DEPUY SYNTHES COMPONENTS REMOVED (FEMORAL, INSERT, TIBIAL). DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150401107, LOT NUMBER: 4710696, COMPONENT TYPE: FEMORAL, DESCRIPTION: ATTUNE CR FEM LT SZ 7 POR. CATALOG NUMBER: 150621007, LOT NUMBER: 4473918, COMPONENT TYPE: TIBIAL, DESCRIPTION: ATTUNE FB TIB BASE SZ 7 POR. CATALOG NUMBER: 151820706, LOT NUMBER: M90N29, COMPONENT TYPE: INSERT, DESCRIPTION: ATTUNE LEFT MEDIAL STABILIZED INSERT SIZE 7 6MM. CONCOMITANT PRODUCT: CATALOG NUMBER: 151811038, LOT NUMBER: 355797, COMPONENT TYPE: PATELLA, DESCRIPTION: ATT MED ANAT PAT 38MM POR.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24007946 ↗
• MalfunctionNov 18, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE IMPLANT WAS SUSPECTED TO BE OUT OF SPEC. ACCORDING TO SURGEON FEMORAL TRIAL WAS APPROPRIATELY FIXATED ON FEMUR AND REAL IMPLANT DID NOT REPLICATE. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23584018 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TOTAL KNEE. ALL IMPLANTS WERE REMOVED AND ANTIBIOTIC SPACER WAS PLACED. THERE WERE NO DELAYS OR PATIENT INJURY. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23560219 ↗
• InjuryOct 23, 2025Adverse 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 INFECTED KNEE. SURGEON PERFORMED EXPLANT AND PLACEMENT OF AB SPACER. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23372983 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE AFFECTED SIDE INVOLVED IN THIS EVENT WAS THE LEFT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23053585 ↗
• MalfunctionSep 11, 2025Device Damaged Prior to Receipt by User; Device Damaged Prior to Use; Device Damaged Prior to Receipt by User; Device Damaged Prior to Use

  IT WAS REPORTED THAT THERE WAS A DEFECT ON A ATTUNE FEMUR IMPLANT. A NEW IMPLANT WAS IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23028030 ↗
• InjuryFeb 5, 2025Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WERE NO REPORTED DELAYS. THEY ALSO CONFIRMED LOOSENING WAS A BONE IMPLANT INTERFACE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21315478 ↗
• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ALL PRIMARY COMPONENTS WERE REMOVED DUE TO INFECTION & SOFT TISSUE DAMAGE FROM THE PATIENT FALLING. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20631592 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND RUPTURED THE PCL. NEEDED A PS KNEE. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 20462563 ↗
• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. REMOVED FEMUR, TIBIA, INSERT, PATELLA AND CEMENT. NO SURGICAL DELAY. NO BROKEN INSTRUMENTS. NO ADVERSE EFFECTS. DOI: UNKNOWN, DOR: (B)(6) 2024 , AFFECTED SIDE : LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19488747 ↗
• InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A POSSIBLE INFECTION OF LEFT TOTAL KNEE. THE SURGEON EXPLANTED THE FOUR IMPLANTS AND PERFORMED WASH OUT AND I&D. THEN PERFORMED 11/2 STAGE REVISION ALONG WITH ANTIBIOTIC CEMENT AND BIOCOMPOSITES. DOI: (B)(6), 2023 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18987890 ↗
• InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PTG IMPLANTED ON (B)(6) 2022. ALWAYS PAINFUL DESPITE PHYSIOTHERAPY. TOTAL PTG REPLACEMENT. DOI: (B)(6) 2022 DOE: (B)(6) 2024 AFFECTED SIDE: LEFT.

  Patient problems: Pain

  MAUDE report 18596141 ↗
• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FEMORAL COMPONENT AND POLY WERE REMOVED AND REPLACED DUE TO FLEXION INSTABILITY. DOI: UNKNOWN, DOR: (B)(6), 2023, AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18230714 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR GI BLEED. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2023, DATE OF EVENT: (B)(6) 2023, (LEFT KNEE). TREATMENT: BLOOD GIVEN; PANTOPRAZOLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16815312 ↗
• InjuryMar 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INFECTED LEFT TOTAL KNEE ARTHROPLASTY: SEROMA. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2022, DATE OF EVENT: (B)(6) 2022, (LEFT KNEE). TREATMENT: IRRIGATION AND DEBRIDEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 13824298 ↗
• MalfunctionSep 15, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PATELLA CLUNK. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO DEVICE AND IS NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2017. DATE OF EVENT (ONSET): (B)(6) 2019. (LEFT KNEE). TREATMENT: NONE.

  Patient problems: Insufficient Information

  MAUDE report 12474640 ↗
• InjuryAug 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO COMPLAINED OF TIBIAL PAIN AND POSSIBLE MEDIAL TIBIAL BASE PLATE LOOSENING AT THE IMPLANT TO BONE INTERFACE. CONVERTED TO SIGMA REVISION KNEE SYSTEM. DOI: (B)(6) 2019, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Pain

  MAUDE report 12345588 ↗
• InjuryAug 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY WITHIN THE JOINT. DOI: (B)(6) 2020 DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12285354 ↗
• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INVOLVED IN AN MVC AND STARTED HAVING UNEXPLAINED PAIN. ALL COMPONENTS WERE REMOVED. THE COMPONENTS WERE WELL FIXED BUT DID HAVE SOME FIBROUS INGROWTH ON SOME PARTS. DOI: (B)(6) 2020; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Adhesion(s); Pain

  MAUDE report 12159073 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: UNKNOW; DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11517511 ↗