ATTUNE 1504-40-204Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10603295042273), received between Jan 23, 2019 and Aug 3, 2026 — classified as 40 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revised due to insufficient mcl and surgeon put in a hinge.DOI: (b)(6) 2025,DOR: (b)(6) 2026,Affected side: Right knee.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 50119282 ↗
• InjuryJul 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PAIN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 25871046 ↗
• InjuryJun 26, 2026Use of Device Problem

  IT WAS REPORTED THAT SURGEON REVISED A PREVIOUS REVISION FOR BETTER FEMORAL FIT AND POSITIONING. NO PATIENT COMPLICATIONS. THE REPORTER DO NOT HAVE ANY ADDITIONAL INFORMATION. DOI: UNKNOWN. DOR: (B)(6), 2026 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25641802 ↗
• MalfunctionSep 12, 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 A DURING A REVISION OF A MEDIAL DISTAL SIZE 4 RIGHT CRS ATTUNE THE FEMUR HAD A MARK ON IT. A MARK WAS VISIBLE ON THE MEDIAL DISTAL CONDYLE. NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 23036457 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD CONTINUED PAIN & EFFUSION. FEMORAL REVISION WAS PERFORMED. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 22875275 ↗
• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 OF 2025. DARTHMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: THE ATTUNE FEMORAL COMPONENT, ATTUNE FEMORAL STEM, AND ATTUNE TIBIAL INSERT WERE REVISED FOR PAIN.

  Patient problems: Pain

  MAUDE report 22716861 ↗
• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 20576699 ↗
• InjuryOct 30, 2024Adverse 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 RIGHT KNEE MOBILIZATION DEVICE (RELATEDNESS): POSSIBLY. PROCEDURE (RELATEDNESS): PROBABLY. DATE OF EVENT: 05 SEP 2024. DATE OF REVISION: NO REVISION. TREATMENT/IMPACT: HOSPITALIZATION/ CLOSED REDUCTION/MANIPULATION.

  Patient problems: Insufficient Information

  MAUDE report 20566326 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE MOBILIZATION. IS THIS EVENT RELATED TO THE STUDY DEVICE? POSSIBLY. IS THIS EVENT RELATED TO THE STUDY PROCEDURE? PROBABLY. DEVICE LOCATION: RIGHT. DATE OF EVENT: (B)(6) 2024. DATE OF IMPLANT: (B)(6) 2024. TREATMENT/IMPACT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 20278207 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION WHICH CAUSED FEMUR TO LOOSEN. THERE WAS FEMORAL LOOSENING AT THE BONE AND CEMENT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20182137 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS RE-IMPLANTED FOLLOWING THE REMOVAL OF AN ANTIBIOTIC SPACER. PATIENT FELL WHEN THEY GOT HOME THE NEXT DAY CAUSING THE MCL TO BE COMPROMISED. PATIENT WAS BROUGHT BACK FOR SURGERY AND ALL FEMORAL COMPONENTS WERE REMOVED AND A SROM HINGE WAS PLACED. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024 DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 19761781 ↗
• InjuryJun 6, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR PATELLA CLUNK SYNDROME. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: 21 MAY 2024 (RIGHT KNEE). TREATMENT: ARTHROSCOPY.

  Patient problems: Pain; Unspecified Musculoskeletal problem

  MAUDE report 19477265 ↗
• InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR SWELLING TO RIGHT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2018. DATE OF EVENT: (B)(6) 2023 (RIGHT KNEE). TREATMENT: DIAGNOSTIC INTERVENTION.

  Patient problems: Swelling/ Edema

  MAUDE report 18928683 ↗
• InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO HINGE DUE TO STIFFNESS. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 17957425 ↗
• InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE PREVIOUSLY IMPLANTED IMPLANTS DIDN¿T DELIVER ENOUGH STABILITY FOR THIS CASE. DOI: (B)(6) 2023. DOR: (B)(6) 2023. UNKNOWN SIDE.

  Patient problems: Joint Laxity; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16707269 ↗
• InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO POSTOPERATIVE PAIN AND INSTABILITY OF THE ATTUNE REVISION RP INLAY, THE FEMORAL COMPONENTS HAD TO BE REVISED TO AN S-ROM HINGED PROSTHESIS.

  Patient problems: Joint Laxity; Pain

  MAUDE report 16632896 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FEMUR WAS CRACKED WHEN IMPLANTING FEMORAL COMPONENTS. FEMUR WAS REPAIRED USING CERCLAGE CABLES. DOE: (B)(6) 2022; RIGHT KNEE.

  Patient problems: Limb Fracture

  MAUDE report 15969975 ↗
• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS INFECTED AND ALL COMPONENTS WERE REMOVED AND A SPACED PLACED. NO PATIENT HARM OCCURRED. A POLY EXCHANGE AND I&D WAS PERFORMED ON (B)(6) 2022. DOI- (B)(6) 2022; DOR- (B)(6) 2022; AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15902604 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A RIGHT TOTAL KNEE REPLACEMENT ON THE (B)(6) 2022 WHERE ATTUNE REVISION IMPLANTS WERE UTILISED. THE PATIENT PRESENTED FOR A REVISION PROCEDURE ON THE (B)(6) 2022 FOR AN UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 15579745 ↗
• InjurySep 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REQUIRED FIRST STAGE RIGHT TOTAL KNEE REVISION FOR A FUNGAL INFECTION OF THE RIGHT KNEE. PT ALREADY HAD IN SITU ATTUNE REVISION IMPLANTS, REQUIRING FULL EXTRACTION OF THE PROSTHESIS.

  Patient problems: Unspecified Infection

  MAUDE report 15493827 ↗
• InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A PAINFUL KNEE. DOI: (B)(6) 2019. DOR:(B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15379062 ↗
• InjuryMay 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. NEW FEMUR AND INSERT IMPLANTED. NO FURTHER INFORMATION AVAILABLE. THE CEMENT MANUFACTURER WAS NOT INDICATED. THERE WAS NO REPORTED LOOSENING. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2018, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT.

  Patient problems: Joint Laxity

  MAUDE report 14397548 ↗
• InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR POST-OPERATIVE SWELLING. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE DEVICE AND IS RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2021, DATE OF EVENT: (B)(6) 2021, (RIGHT KNEE). TREATMENT: ASPIRATION AND DRAINAGE, KNEE BRACE.

  Patient problems: Swelling/ Edema

  MAUDE report 14194090 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PAIN NOT RESOLVING AS EXPECTED IN KNEE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS PROBABLY RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019; DATE OF EVENT (ONSET): (B)(6) 2021; DATE OF REVISION: (B)(6) 2022; (RIGHT KNEE). TREATMENT: THE REVISION OCCURRED ON (B)(6) 2022. THE CLINICAL DATABASE INDICATES THE FEMORAL SIDE DEVICES AND INSERT WERE REVISED.

  Patient problems: Pain

  MAUDE report 14140920 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INTRAOP BONE FRACTURE - FEMORAL. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. (RIGHT KNEE). TREATMENT: OPEN REDUCTION INTERNAL FIXATION.

  Patient problems: Bone Fracture(s)

  MAUDE report 14083682 ↗