ATTUNE 1504-11-206Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295042051), received between Dec 2, 2019 and Apr 22, 2025 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2025Osseointegration Problem; Osseointegration Problem

  ON (B)(6) 2023 PATIENT HAD UNDERWENT RIGHT KNEE WITH VELYS. ON (B)(6) 2025, PATIENT UNDERWENT A RIGHT TKA REVISION DUE TO PAIN, SWELLING, AND INSTABILITY. PATIENT WAS FOUND TO HAVE ASEPTIC FEMORAL AND TIBIAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THERE WAS UNDERLYING FIBROUS TISSUE AND THE CEMENT WAS REMOVED AFTER THE TIBIAL COMPONENT AND FEMORAL COMPONENTS WERE REMOVED. THE PATELLA WAS NOTED TO HAVE BEEN REMOVED AS WELL, BUT THERE WAS NO MENTION IMPLANT LOOSENING RELATED TO THE PATELLA. COMPETITOR IMPLANTS WERE PLACED AT REVISION. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fibrosis; Inadequate Osseointegration; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 21882283 ↗
• InjuryDec 4, 2024Osseointegration Problem; Osseointegration Problem

  ON (B)(6) 2023, THE PATIENT HAD A RIGHT KNEE ARTHROPLASTY TO ADDRESS OSTEOARTHRITIS. ATTUNE KNEE IMPLANTS WERE IMPLANTED AND VELYS WAS USED. ON (B)(6) 2024, THE PATIENT HAD REVISION RIGHT TOTAL ARTHROPLASTY TO ADDRESS MECHANICAL ASEPTIC LOOSENING OF RIGHT TOTAL KNEE ARTHROPLASTY. IT WAS REPORTED THAT PATIENT HAD RECURRENT EPISODES OF ACHING PAIN, INSTABILITY, AND SWELLING. THE TIBIAL TRAY AND FEMORAL COMPONENT WERE EASILY REMOVED AND THERE WAS NOTED FIBROUS TISSUE UNDERLYING THE COMPONENTS. COMPETITOR PRODUCTS WERE IMPLANTED DURING THIS PROCEDURE. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Inadequate Osseointegration; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 20845187 ↗
• InjuryApr 12, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THEY HAVE TO CHANGE ALL THE PROSTHESIS BECAUSE ALL THE SETS NEEDED FOR THE OPERATION CAN'T BE DELIVERED. RELATED TO (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19097587 ↗
• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT NEEDS TO SPEAK WITH SOMEONE ABOUT PRODUCT FAILURE IN HER KNEE. HER DR TOLD HER TO CALL US AS HE HAS TO DO SURGERY AGAIN. DOI: (B)(6) 2022. DOR: UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Joint Laxity; Loss of Range of Motion; Muscular Rigidity; Osteolysis; Pain; Swelling/ Edema

  MAUDE report 16453588 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ATTUNE CEMENTLESS RP PS KNEE COMPONENTS WERE REMOVED DUE TO INFECTION. DOI: (B)(6) 2022. DOR: (B)(6) 2022. UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15427287 ↗
• MalfunctionJul 19, 2021Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION RECEIVED STATED THAT NO INSTRUMENT WAS BROKEN, NO LOOSENING, AND NO ADVERSE CONSEQUENCES THAT AFFECT THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12194081 ↗
• InjuryJul 6, 2021Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL TRAY AND FEMORAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. PATIENT HAS A RIGHT TOTAL ATTUNE PRESSFIT KNEE DONE BY A SURGEON. THE TIBIAL TRAY SUBSIDED AND FALLEN INTO REVERSE SLOPE. SURGEON WENT IN WITH PLANS TO REVISE THE TIBIAL TRAY ONLY. SURGEON CHECKED THE FEMORAL COMPONENT AND AFTER MULTIPLE TAPS, IT CAME OFF TOO. IT IS UNKNOWN IF THE FEMORAL COMPONENT WOULD HAVE GROWN IN OR NOT. IT HAS BEEN IN FOR 8 WEEKS. THE PATELLA WAS WELL FIXED AND RETAINED. WHEN THE REVISION COMPONENTS WERE IMPLANTED, THE TIBIAL TRAY SAT 2MM PROUD. A THINNER INSERT WAS UTILIZED. DOI: (B)(6) 2021; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12120562 ↗
• InjuryApr 16, 2021Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO KNEE PAIN AND LOOSENING OF THE TIBIA AND FEMUR COMPONENTS AT THE IMPLANT TO BONE INTERFACE. NO BONE IN GROWTH. DOI: (B)(6) 2020. DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 11682613 ↗
• InjuryFeb 15, 2021Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF THE FEMUR AT THE BONE TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: (B)(6) 2020, DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11328015 ↗
• InjuryJan 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR CARDIAC DECOMPENSATION ON BRONCHOPATHIA. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2019 (RIGHT KNEE).

  Patient problems: Heart Failure; No Code Available

  MAUDE report 9612250 ↗
• MalfunctionDec 2, 2019Noise, Audible; Patient Device Interaction Problem; Noise, Audible; Patient Device Interaction Problem

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR HYPERSENSITIVE SCAR KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2019, (RIGHT KNEE).

  Patient problems: Adhesion(s); Edema; No Code Available; Pain

  MAUDE report 9397420 ↗