ATTUNE 1504-01-205Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295041481), received between Jun 2, 2020 and Jun 24, 2026 — classified as 12 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON BELIEVED THERE WAS INSTABILITY WITH FEMUR COMPONENT. THEY REMOVED FEMUR AND PLACED REVISION COMPONENT. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25610921 ↗
• InjuryFeb 17, 2026Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAD A TOTAL KNEE DONE (B)(6) 2024. SURGEON AT THE TIME OF SURGERY DID NOT RESURFACE THE PATELLA. PATIENT WAS COMPLAINING OF PAIN AND WENT TO SEE A DIFFERENT ORTHOPEDIC SURGEON WHO AGREED TO DO A REVISION TO RESURFACE THE PATELLA. WHILE THEY WERE IN THERE, THE SURGEON ALSO SAW THAT THE FEMORAL COMPONENT WAS A LITTLE LOOSE AND COULD'VE BEEN CONTRIBUTING TO THE PATIENT'S KNEE PAIN, SO REVISED THE FEMUR AS WELL. IT WAS STATED THAT THE FEMUR WAS LOOSE. LOOSENING INTERFACE WAS MARKED AS NON-CEMENTED. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 24367558 ↗
• InjuryAug 5, 2025Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT BOTH CEMENTLESS FEMUR AND CEMENTLESS TIBIA WERE LOOSE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22717203 ↗
• InjuryApr 28, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S BONE SCAN CAME BACK HOT AND SURGEON REVISED THE KNEE. THE TIBIA WAS LOOSE AND THE FEMUR HAD LITTLE BONE IN GROWTH. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR:(B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21919182 ↗
• MalfunctionFeb 3, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT PATIENT WAS SCHEDULED FOR TOTAL KNEE REPLACEMENT ON JANUARY 20, 2025. THERE IS A HAIR EMBEDDED IN THE PORO COATING.

  Patient problems: Insufficient Information

  MAUDE report 21294083 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE SURGERY VIA TKA WITH THE IMPLANT IN QUESTION. THE IMPLANT IN QUESTION WAS REMOVED DUE TO INFECTION. ON (B)(6) 2024, THE SURGEON NOTED THAT THE IMPLANT IN QUESTION, WHICH HAD BEEN EXTRACTED IN THE PAST, WAS YELLOWISH. IT WAS ALSO NOTED THAT THE IMPLANT IN QUESTION MAY HAVE BEEN OXIDIZED. NO FURTHER INFORMATION IS AVAILABLE. DOI: ON (B)(6) 2022, DOE: ON (B)(6) 2023.

  Patient problems: Unspecified Infection

  MAUDE report 18836001 ↗
• InjuryAug 1, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IMPLANT IS DESIGNATED AS A RIGHT BUT WAS MISTAKENLY IMPLANTED IN THE INCORRECT LEFT SIDE, RESULTING IN A REVISION TO CORRECT. THE ISSUE WAS IDENTIFIED BY X-RAY.

  Patient problems: Insufficient Information

  MAUDE report 17434241 ↗
• MalfunctionFeb 21, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE SURGERY VIA TKA FOR KNEE OA WITH THE FEMORAL COMPONENT IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT MADE AN APPOINTMENT ON (B)(6) 2023, AFTER COMPLAINING OF SUDDEN INABILITY TO STRAIGHTEN HIS KNEE AND WAS HOSPITALIZED DUE TO THE ABSENCE OF THE ATTENDING PHYSICIAN. THEN, AN EXAMINATION REVEALED THAT THERE HAD BEEN A CLEAR POSTOPERATIVE CHANGE IN ALIGNMENT. A REVISION SURGERY WILL BE PERFORMED SOON. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Loss of Range of Motion

  MAUDE report 16412468 ↗
• InjuryFeb 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANTS WERE REMOVED DUE TO JOINT INFECTION. THERE WERE NO DEFICIENCIES NOTED AND THERE WAS NO DELAY IN PROCEDURE. THE IMPLANTS ARE NOT AVAILABLE FOR RETURN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13408055 ↗
• InjuryJan 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD TKA ON (B)(6) 2021. THE PATIENT EXPERIENCED STIFFNESS AND LOST ROM SOME TIME FOLLOWING PROCEDURE. THE SURGEON DISCOVERED PATIENT DEVELOPED ARTHROFIBROSIS AROUND THE KNEE CAUSING STIFF. REVISION COMPLETED IN WHICH THE FEMORAL COMPONENT AND INSERT WERE EXPLANTED AND REPLACED WITH A PS FEMORAL COMPONENT AND PS INSERT. THE TIBIAL BASE PLATE AND PATELLA REMAINED. NO SURGICAL DELAY. DOI: (B)(6) 2021; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Loss of Range of Motion; Muscular Rigidity

  MAUDE report 13283206 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A MANIPULATION UNDER ANESTHESIA TO TREAT STIFFNESS AND REDUCED RANGE OF MOTION. NO PRODUCTS WERE REVISED. DOI: (B)(6) 2021. DOE: UNK. UNK KNEE.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 11891471 ↗
• InjuryOct 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020 VIA TKA FOR THE PATIENT¿S RIGHT KNEE JOINT. IT WAS REPORTED THAT THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2020 DUE TO INFECTION WHICH OCCURRED AFTER THE PRIMARY SURGERY. THE SURGEON REMOVED THE FEMORAL COMPONENT, THE TIBIAL TRAY AND THE TIBIAL INSERT AND IRRIGATED THE KNEE JOINT. HE SET ANTIBIOTIC CEMENT MOLD AND COMPLETED THE REMOVAL SURGERY WITHOUT ANY SURGICAL DELAY. THE SURGEON PLANS THE REVISION SURGERY AFTER THE INFECTION GOES AWAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10690053 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REMOVAL OF ARTICULATING ATTUNE ANTIBIOTIC SPACER WAS PERFORMED AND PLACEMENT OF AN ATTUNE REVISION CONSTRUCT DUE TO INFECTION ABATEMENT. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10258331 ↗
• InjuryJun 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. THE KNEE WAS REVISED TO A CEMENT SPACER. DOI: (B)(6) 2020. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10112139 ↗