ATTUNE 1504-01-206Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295041498), received between Jul 17, 2017 and Apr 30, 2026 — classified as 20 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ PAIN/STIFFNESS. DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: (B)(6) 2026. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: (B)(6) 2026. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: COMPONENTS REMOVED (FEMORAL, INSERT, TIBIAL) DEPUY SYNTHES PRODUCTS USED. CATALOG NUMBER: 150401206. LOT NUMBER: 4035479. COMPONENT TYPE: FEMORAL. DESCRIPTION: ATTUNE CR FEM RT SZ 6 POR. CATALOG NUMBER: 150621006. LOT NUMBER: JA06A1468. COMPONENT TYPE: TIBIAL. DESCRIPTION: ATTUNE FB TIB BASE SZ 6 POR. CATALOG NUMBER: 152020606. LOT NUMBER: M5345X. COMPONENT TYPE: INSERT. DESCRIPTION: ATTUNE RIGHT MEDIAL STABILIZED INSERT SIZE 6 6MM. CATALOG NUMBER: 3322020. LOT NUMBER: 4513647. COMPONENT TYPE: CEMENT. DESCRIPTION: SMART SET BONE CEMENT 20G.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 25045021 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLAINED OF EXTREME TIBIAL PAIN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24647611 ↗
• InjuryMar 6, 2026Osseointegration Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ ASEPTIC LOOSENING: DATE OF EVENT: FEBRUARY 9,2026, DATE OF IMPLANT: ON (B)(6) 2025, DATE OF REVISION: ON (B)(6) 2026, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: TREATMENT/IMPACT: COMPONENTS REMOVED (FEMORAL, TIBIAL, AND INSERT). DEPUY SYNTHES PRODUCTS USED: NO INFORMATION PROVIDED. CATALOG NUMBER: 150401206, LOT NUMBER: 4794037, COMPONENT TYPE: FEMORAL, DESCRIPTION: ATTUNE CR FEM RT SZ 6 POR, CATALOG NUMBER: 150621006, LOT NUMBER: JA06A0524, COMPONENT TYPE: TIBIAL, DESCRIPTION: ATTUNE FB TIB BASE SZ 6 POR, CATALOG NUMBER: 152020606, LOT NUMBER: M8975U, COMPONENT TYPE: INSERT, DESCRIPTION: ATTUNE RIGHT MEDIAL STABILIZED INSERT SIZE 6 6MM, CONCOMITANT PRODUCTS INVOLVED: CATALOG NUMBER: UNKNOWN KNEE TROCHLEAR, LOT NUMBER: NO INFORMATION PROVIDED, COMPONENT TYPE: NO INFORMATION PROVIDED, DESCRIPTION: NO INFORMATION PROVIDED, CATALOG NUMBER: UNKNOWN KNEE PATELLA, LOT NUMBER: NO INFORMATION PROVIDED, COMPONENT TYPE: NO INFORMATION PROVIDED, DESCRIPTION: NO INFORMATION PROVIDED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24530152 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: PATIENT: (B)(6). SURGERY DATE: (B)(6) 2024. REASON FOR REVISION: FEMORAL COMPONENT REVISION FOR FEMORAL CYST. REF: (B)(4). LOT: 4332569. DESCRIPTION: SIZE 6 CEMENTLESS RIGHT CR FEMUR. OPERATIVE SIDE: RIGHT. EXPLANT DATE: (B)(6) 2025.

  Patient problems: Cyst(s); Insufficient Information; Pain

  MAUDE report 24484795 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH STAGE 1 OF 2 REVISION. ANTIBIOTIC SPACER. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23879043 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD STABLE KNEE IN OR AFTER SURGERY. THE PATIENT GOT UP IN RECOVERY AND POPPED SOMETHING. THE PATIENT WAS BROUGHT BACK TO OR AND IT SEEMED THAT SHE LOST HER POSTERIOR CAPSULE. KNEE WAS EXPLANTED AND RP CRS WAS IMPLANTED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23476494 ↗
• InjurySep 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT FELL ONE DAY POST-OP WHILE USING THE BATHROOM AFTER A RTKA AND DISLOCATED THEIR FEMUR POSTERIOR TO THE TIBIA. ALL COMPONENTS REMOVED AND PATIENT WAS CONVERTED TO AN SROM HINGE KNEE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 23004065 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INSTABILITY. INSTABILITY WAS NOT DUE TO POLY WEAR. PATIENT REPORTED FEELING A CHANGE AND PAIN AFTER DOING WEIGHTED LEG PRESSES IN PHYSICAL THERAPY. BOTH FEMUR AND TIBIA REQUIRED EXTENSIVE USE OF SAW AND OSTEOTOMES TO REMOVE. THERE WAS NO REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY. NO COMPONENTS WERE UNDERSIZED IN THE PRIMARY SURGERY. THE FEMUR OR TIBIA WERE NOT EXCESSIVELY RESECTED/HAD JOINT LINE RAISED DURING THE PRIMARY SURGERY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22554019 ↗
• InjuryNov 14, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE FEMUR WAS BROKEN UPON IMPLANTATION OF INDEX PORCOAT FEMUR. APPEARED LOOSE ON X-RAY. WASN¿T LOOSE. REMOVED THE PORCOAT AND CEMENTED IN A PS ATTUNE FEMUR. THERE WAS LOOSENING AT THE NON-CEMENTED INTERFACE. THE CEMENT MANUFACTURER WAS DEPUY. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Limb Fracture

  MAUDE report 20682708 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY FOR THE RIGHT KNEE. CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR - PE DEVICE AND PROCEDURE(RELATEDNESS): DEVICE RELATED: DEFINITELY NOT PROCEDURE RELATED: POSSIBLY DATE OF EVENT: 19/SEP/24 . TREATMENT/IMPACT: :NO INFORMATION PROVIDED.

  Patient problems: Cardiogenic Shock; Cardiovascular Dysfunction/Insufficiency; Low Blood Pressure/ Hypotension; Pulmonary Embolism

  MAUDE report 20438872 ↗
• MalfunctionOct 26, 2023Device Damaged Prior to Use; Device Contaminated During Manufacture or Shipping; Device Damaged Prior to Use; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT WHEN PRODUCT WAS OPENED THE INNER PLASTIC CONTAINER HAD A HOLE IN IT. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? NO. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES? NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED? UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN. (B)(4). DEVICE PROPERTY OF? NONE. DEVICE IN POSSESSION OF? NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST? TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18016014 ↗
• MalfunctionMay 18, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE SEAL ON THE PACKAGE WAS COMPROMISED. PRODUCT NOT STERILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16956076 ↗
• InjuryNov 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL TOTAL KNEE ARTHROPLASTY. ALL COMPONENTS WERE REMOVED AND REVISED TO AN FB ATTUNE REVISION CONSTRUCT WITH A STRYKER CONE AND CEMENTED STEMS. THE CEMENT MANUFACTURER WAS NOT INDICATED. THERE WAS NO SURGICAL DELAY. DOI: OCT 6, 2021. DOR: OCT 31, 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15806076 ↗
• InjurySep 1, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  CLINICAL ADVERSE EVENT RECEIVED FOR LOOSENING OF PRESS-FIT PROSTHESIS. EVENT IS NOT SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2021; DATE OF EVENT: (B)(6) 2022; (RIGHT KNEE). TREATMENT: SURGICAL INTERVENTION (UNSPECIFIED).

  Patient problems: Insufficient Information

  MAUDE report 15337665 ↗
• InjuryAug 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT DETAILS: EVENT: MUA FOR RT KNEE ARTHROFIBROSIS. EVENT DATE: (B)(6) 2021. EVENT DAY: 41. SITE AWARENESS DATE: 20 DEC 2021. IF EVENT DATE IS EQUAL TO DATE OF PRIMARY STUDY PROCEDURE, WHEN DID EVENT OCCUR?: PRIOR TO PROCEDURE. ALERT DATE: 02 FEB 2022 .EVENT OCCURRED: POST-OP. COUNTRY OF EVENT: US. SUBJECT COHORT: MANUAL. OPERATIVE SIDE: BLANK. ROBOTIC CASE ID: BLANK. DATE OF TOTAL KNEE ARTHROPLASTY: (B)(6) 2021.

  Patient problems: Adhesion(s)

  MAUDE report 15137979 ↗
• InjuryMay 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON WAS REVISING THE KNEE DUE TO STABILITY REASONS. SALES REP WAS NOT IN ACTUAL SURGERY BECAUSE SURGEON USED A COMPETITIVE REVISION IMPLANT. SURGEON DID NOT PROVIDE ANY ADDITIONAL INFORMATION AFTER REVISION. DOI: (B)(6) 2020; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14497117 ↗
• InjuryApr 13, 2022Osseointegration Problem; Osseointegration Problem

  REVISION OF ATTUNE CEMENTLESS CR RP TKR. REVISED DUE TO PAIN & LOSS OF FUNCTION OVER TIME - BONE SCAN SHOWED LOOSENING - MORE PRONOUNCED ON TIBIAL SIDE. REVISED TO ATTUNE REVISION WITH STEMS & SLEEVES - BONE SCLEROTIC ON TIBIAL SIDE. ON REMOVAL OF PRIMARY IMPLANTS - FEMUR - NOTED SOME BONE INGROWTH ON ANTERIOR FLANGE & CHAMFER BUT NOT ON DISTAL & POSTERIOR CONDYLES. FEMUR WAS OBVIOUSLY LOOSE. TIBIA - DID NOT APPEAR TO HAVE BONE IN GROWTH TO POROUS COATING - ? FIBROUS INGROWTH ONLY. DOI: (B)(6) 2021, DOR: (B)(6) 2022, UNKNOWN KNEE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 14102380 ↗
• InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INSTABILITY. THE SURGEON REMOVED AND REPLACED THE FEMORAL, TIBIAL AND INSERT COMPONENTS. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 13561980 ↗
• InjuryJan 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY. EVENT IS POSSIBLY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021 DATE OF EVENT (ONSET): (B)(6) 2021 (RIGHT KNEE). TREATMENT: REVISION OF ALL COMPONENTS.

  Patient problems: Joint Laxity

  MAUDE report 13366605 ↗
• InjuryMay 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR KNEE PAIN AT PES ANSERINUS, RIGHT HAND SIDE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. (RIGHT KNEE).

  Patient problems: No Code Available; Pain

  MAUDE report 10047811 ↗
• InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2018 VIA TKA BY IMPLANTING THE TIBIAL INSERT (P/N: 151630606), THE FEMORAL COMPONENT (P/N: 150401206) AND THE TIBIAL TRAY (P/N: 150611007) ON THE PATIENT¿S RIGHT KNEE JOINT. IT WAS REPORTED THAT AORTIC ANEURYSM OCCURRED AROUND (B)(6) 2019. THE PATIENT RECOVERED.

  Patient problems: No Code Available; Perforation of Vessels

  MAUDE report 9934764 ↗
• InjuryJul 17, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  CLINICAL DER STATES AE RECEIVED FOR DEEP VENOUS THROMBOSIS.

  Patient problems: Thromboembolism

  MAUDE report 6716837 ↗