ATTUNE 1504-10-207Recalls & reported problems

Summary

The FDA's MAUDE database contains 188 adverse event reports that list this exact device (DI 10603295041788), received between Nov 4, 2017 and Aug 13, 2026 — classified as 1 death, 172 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (28 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 188 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2026Loss of or Failure to Bond

  It was reported that patient was revised due to pain with knee. Upon revision for pain, infection was revealed. Grossly loose implants. And puss. Also tibial component was loose at cement to implant interface.DOI: (b)(6) 2022.DOR: (b)(6) 2026.Affected Side: Right.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 50239366 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIA AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT THE PATIENT REVISED TO NICKEL FREE IMPLANT. IMPLANT LOOSENING DUE TO SEVERE NICKEL ALLERGY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 24800674 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION SURGERY WITH DOWNSIZING OF THE FEMUR COMPONENT AND REVISION OF THE TIBIAL INSERT AND PATELLA COMPONENTS. THE PATIENT DEVELOPED ARTHROFIBROSIS, RESULTING IN KNEE STIFFNESS AND IMPAIRED JOINT MOVEMENT, WHICH LED TO AN INABILITY TO ADEQUATELY EXTEND OR FLEX THE KNEE. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE-UNKNOWN KNEE.

  Patient problems: Arthrofibrosis; Loss of Range of Motion; Muscular Rigidity

  MAUDE report 24507012 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A PAINFUL KNEE. DOI: (B)(6) 2022. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24326673 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION OF AN ATTUNE OCCURRED DUE TO INFECTION. ORIGINAL SURGERY WAS DONE ABOUT TWO YEARS AGO. EXACT DATE UNKNOWN. RIGHT SIDE. COMPONENTS WERE WELL FIXED. ALL COMPONENTS WERE REMOVED. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 24166787 ↗
• InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS WAS SECOND TIME AROUND FOR INFECTION. PARTS WERE REMOVED AND NEW PARTS WERE IMPLANTED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24114567 ↗
• MalfunctionJan 16, 2026Device Damaged Prior to Receipt by User

  IT WAS REPORTED THE DEVICES WERE RECEIVED DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24098329 ↗
• MalfunctionJan 16, 2026Device Damaged Prior to Receipt by User

  IT WAS REPORTED THE DEVICES WERE RECEIVED DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24097772 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FLEXION CONTRACTURE. NO OTHER INFORMATION WAS KNOWN. DOI: (B)(6) 2021, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Septic loosening

  MAUDE report 23841461 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN/INSTABILITY. DOI: UNKNOWN, DOR: ON (B)(6) 2025, AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23536147 ↗
• InjuryNov 6, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO TIBIA AND FEMUR LOOSENING AT THE IMPLANT CEMENT INTERFACE. DOI- (B)(6) 2014. DOR- (B)(6) 2025. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23485315 ↗
• InjuryNov 3, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED A REVISION OF AN RIGHT-SIDE FEMUR ATTUNE PSRP OCCURRED ON (B)(6) 2025 DUE TO A FALL AND LOOSE FEMUR CONSTRUCT. IT ALSO LOOKED LIKE THE TIBIA SUBSIDED SLIGHTLY. ALL COMPONENTS WERE REMOVED EXCEPT THE PATELLA. THE FEMUR WAS LOOSE AND CAME OUT WITH NO CEMENT ON THE LATERAL SIDE OF THE FEMORAL COMPONENT. THE MEDIAL SIDE OF THE IMPLANT HAD CEMENT ON IT. THE TIBIA CAME OUT CLEAN WITH NO CEMENT ON IT, BONE/CEMENT INTERFACE WAS INTACT. NO ALLEGATION MADE AGAINST THE PATELLA COMPONENT OR CEMENT. PATELLA COMPONENT WAS NOT REVISED. THE CONSTRUCT WAS IMPLANTED ON (B)(6) 2017.

  Patient problems: Fall

  MAUDE report 23449673 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION OF AN RIGHT ATTUNE TOTAL KNEE REPLACEMENT WHICH WAS DONE (B)(6), 2024. REASON FOR REVISION IS DUE TO INFECTION. COMPONENTS WERE WELL FIXED DESPITE THE DEEP INFECTION. THE SURGEON COMMENTED HOW WELL FIXED THE TIBIAL SLEEVE WAS. ALL COMPONENTS WERE REMOVED. PATIENT HAD A UKR PREVIOUSLY WHICH WAS LOOSED AND WAS REVISED TO THIS. DEPUY PRODUCTS WERE NOT USED IN THE UKR THE SITE WAS DEEMED AS NOT INFECTED AT THE TIME.

  Patient problems: Unspecified Infection

  MAUDE report 22838445 ↗
• InjuryMay 21, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF PATELLA AND FEMUR AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS DEPUY SYNTHES. PATIENT HAD LOOSE PATELLA AND FEMUR. ALL IMPLANTS WERE REMOVED AND RP CRS CONSTRUCT WAS IMPLANTED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22059702 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TIBIA WAS VERY LOOSE (CAME OUT BY HAND). FEMUR WAS SOMEWHAT FIXED, BUT INFECTION WAS FOUND INTRA-OP AND ALL COMPONENTS WERE REMOVED AND REPLACED. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21927646 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD KNEE REVISION FOR AN UNSTABLE KNEE. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21873851 ↗
• InjuryApr 4, 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 GLOBAL INSTABILITY. THE LIGAMENTS ARE CHRONICALLY LOOSE. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21774553 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO ARTHROFIBROSIS. THERE WAS NO LOOSENING OF IMPLANTS. SURGICAL DELAY WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 21351226 ↗
• MalfunctionFeb 5, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IN THEATRE, OPENED ATTUNE PS IMPLANT SIZE 7 RIGHT. IT WAS REPORTED THAT THE INNER STERILE PACKAGING WOULD NOT SEPARATE FROM THE OUTER PACKAGE. SCRUB NURSE TUGGED THE TAB AND IT PULLED AWAY FROM THE PACKAGING. SCRUB NURSE THEN TRIED TO RETRIEVE THE IMPLANT VIA PIERCING THE PAPER AND PULLING THE IMPLANT INTO THE STERILE FIELD. THE INNER PACKAGE WOULD NOT RELEASE FROM THE OUTER PACKAGE. AFTER SEVERAL ATTEMPTS SURGEON EXPRESSED CONCERN OVER STERILITY AND COMPROMISED PACKAGING. DECISION WAS MADE TO ABORT ORIGINAL IMPLANT AND OPEN A SECOND IMPLANT. SECOND IMPLANT WAS OPEN AND DEPLOYED SUCCESSFULLY INTO THE STERILE FIELD. THE SURGERY WAS DELAYED 5 MINUTES. THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21312653 ↗
• InjuryFeb 4, 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 FIBROSIS. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 21307119 ↗
• InjuryJan 29, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT INITIATED COMPLAINT: IT WAS REPORTED BY THE PATIENT THAT THE PATIENT HAD TOTAL KNEE REVISION RIGHT DUE TO PROSTHETIC THAT DID NOT ADHERE. THIS PROSTHETIC WAS CEMENTED AND DID NOT ADHERE. PATIENT HAD 3RD SURGERY IN 2024 THAT CAUSED LOTS OF PAIN, MISSED WORK, 3RD SURGERY.

  Patient problems: Pain

  MAUDE report 21263614 ↗
• InjuryJan 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 FOR PAINFUL RIGHT KNEE. PATIENT HAD A SIGNIFICANT FLEXION CONTRACTURE. THE SURGEON OPTED FOR A FEMORAL TIBIAL REVISION TO BALANCE THE KNEE. DOI: UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Contracture; Pain

  MAUDE report 21222575 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON SUSPECTS LOOSENING OF THE TIBIAL BASEPLATE AS PER THE X-RAY AND A REVISION SURGERY WAS PERFORMED (B)(6) 2024. IT WAS NOTED THAT THE CEMENT WAS WELL BONDED TO THE IMPLANT SURFACE ON THE TIBIA AND FEMORAL COMPONENTS. THE IMPLANTS SEEMED WELL FIXED, BUT WERE REMOVED DUE TO PRESENCE OF INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20784140 ↗
• MalfunctionNov 19, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED ON (B)(6) 2024 WHEN OPENING THE FIRST PACKAGE OF THE IMPLANTS, IT WAS NOTICED THAT THE SECOND PACKAGE WAS NOT IN OPTIMAL CONDITIONS FOR USE. SURGERY WAS DELAYED 5 MINUTES WHILE ANOTHER IMPLANT WAS PREPARED. PROCEDURE COMPLETED SUCCESSFULLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20722159 ↗
• MalfunctionNov 15, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT WHEN OPENING THE FIRST PACKAGING OF THE IMPLANT, IT WAS NOTICED THAT THE SECOND PACKAGING WAS IN POOR CONDITION. THE SEAL WAS NOT BREACHED. ANOTHER IMPLANT WAS USED TO PROCEED WITH THE PROCEDURE. THERE WAS A FIVE (5) MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20694871 ↗