ATTUNE 1504-01-106Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295041351), received between Feb 27, 2019 and Sep 28, 2026 — classified as 14 injuries, 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50915219 ↗
• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FALLING AFTER TOTAL KNEE REPLACEMENT. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall

  MAUDE report 25354688 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23821726 ↗
• MalfunctionSep 12, 2025Difficult to Insert; Device Damaged Prior to Use; Difficult to Insert; Device Damaged Prior to Use

  IT WAS REPORTED THAT CUTS WERE OFF AND IMPLANT WOULD NOT FIT PROPPER. NEEDED TO SWITCH TO CEMENTED FEMUR. DOE: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23039910 ↗
• InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED PRIMARY KNEE AND SURGEON REMOVED ALL IMPLANTS AND REPLACED WITH FUNCTIONAL SPACER. THERE WERE NO COMPLAINTS OR DELAYS. IMPLANTS WERE NOT BEING RETURNED. AFFECTED AREA: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22140628 ↗
• InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6) STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR - PE DEVICE AND PROCEDURE(RELATEDNESS): DEVICE RELATED: DEFINITELY NOT PROCEDURE RELATED: POSSIBLY DATE OF EVENT: 19/SEP/24 DATE OF IMPLANT: NO INFORMATION PROVIDED DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: LEFT. TREATMENT/IMPACT: NO INFORMATION PROVIDED.

  Patient problems: Pulmonary Embolism

  MAUDE report 20452291 ↗
• MalfunctionAug 14, 2024Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE DELAY WAS BECAUSE THE SURGEON DECIDED TO CEMENT THE COMPONENTS WHICH ADDED APPROXIMATELY 20 MINUTES AND THERE WAS NO KNOWN ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19980041 ↗
• InjuryJun 11, 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 REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 19514794 ↗
• InjuryDec 19, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT HAD A COMPLETE KNEE REPLACEMENT INCLUDING A 38MM PATELLA ATTUNE KNEE IN (B)(6) 2019. IT HAD TO BE REVISED IN 2021 AND AGAIN IN 2023. ON (B)(6) 2021, THE PATIENT HAD A LEFT KNEE REVISION TO ADDRESS PAIN, INSTABILITY AND ¿GENERAL LOOSENING PROSTHESIS¿. PATHOLOGY REPORTS FROM THE SURGERY NOTED THE PATIENT HAD TISSUE REACTION FROM POLYETHYLENE DEBRIS. THE TIBIAL TRAY, INSERT, AND FEMORAL COMPONENT WERE REMOVED AND COMPETITOR COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. THE PATELLA WAS LEFT IN-SITU. (B)(4). IN 2023, THE PATIENT WAS REVISED TO ADDRESS PAIN, GIANT CELL REACTION, TISSUE REACTION DUE TO POLYETHYLENE DEBRIS. ONLY THE DEPUY PATELLA WAS REVISED. COMPETITOR PATELLA WAS IMPLANTED ALONG WITH COMPETITOR CEMENT DURING THIS PROCEDURE. (B)(4). DOI: (B)(6) 2019 DOR: 2023 LEFT PATELLA ONLY. DOI: (B)(4). 2019. DOR: (B)(4) 2021. AFFECTED SIDE: LEFT.

  Patient problems: Joint Laxity; Pain; Unspecified Tissue Injury

  MAUDE report 18356856 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT REVISION AS THE SURGEON REVISED THE KNEE TO A REVISION CONSTRUCT FOR KNEE STABILITY. THE IMPLANTS WERE WELL FIXED AND SIZED APPROPRIATELY ACCORDING TO THE SURGEON. NO INFORMATION IS AVAILABLE ON WHAT CEMENT WAS USED FOR THE PATELLA. NO ADDITIONAL INFORMATION AVAILABLE. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17832755 ↗
• InjurySep 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PERIPROSTHETIC KNEE FRACTURE. DOI: UNKNOWN DOR: (B)(6) 2023.. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 17806936 ↗
• InjuryJul 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THE CEMENT MANUFACTURER WAS UNKNOWN. THERE WAS NO LOOSENING AND NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15028943 ↗
• InjuryFeb 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS GROWING A STAPH INFECTION. REMOVAL OF IMPLANTS WAS IN ORDER TO PLACE AN ANTIBIOTIC SPACER TO HELP CLEAR THE INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13569595 ↗
• InjuryAug 16, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS KNEE PAIN AND LOOSENING OF THE FEMORAL AND TIBIAL COMPONENT AT THE BONE TO IMPLANT INTERFACE. THE X-RAYS SHOWED SIGNS OF LOOSENING. IMPLANTS WERE REMOVED AND REVISION IMPLANTS WERE IMPLANTED. NO IMPLANTS OR INSTRUMENTS WERE DAMAGED OR LOST. THE CEMENT MANUFACTURER WAS NOTED TO BE UNKNOWN. NO SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 12324034 ↗
• MalfunctionApr 27, 2020Inadequacy of Device Shape and/or Size; Manufacturing, Packaging or Shipping Problem; Inadequacy of Device Shape and/or Size; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT THE TKA SURGERY FOR OA WITH THE FEMORAL COMPONENT (P/N: 150401106) IN QUESTION. DURING THE SURGERY, THE PEG HOLE AND PEG OF THE COMPONENT POSITIONS WERE DIFFERENT FROM EACH OTHER ABOUT 3-4MM. THE PEG LOCATED BEHIND THE PEG HOLE, AND THE SURGEON EXTEND THE PEG HOLE ABOUT 3MM WITH A GOUGE, AND HE INSERTED THE IMPLANT. THE IMPLANT SEEMED TO BE INSERTED PROPERLY. DURING THE IMPLANT TO THE RIGHT, THE SURGEON HAD DIFFICULTY IN INSERTING THE FEMORAL COMPONENT (P/N: 150401206) THOUGH IT IS UNKNOWN THAT THE PEG HOLE WAS OUT OF PLACE OR NOT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 10002505 ↗
• InjuryMar 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT KNEE REVISED TO ADDRESS INFECTION, WITH STAGE ONE EXPLANTATION OF DEPUY PRODUCTS, AND PLACEMENT OF ANTIBIOTIC SPACER. DOI: (B)(6) 2019; DOR: (B)(6) 2019. TREATMENT: EXPLANTATION OF FEMUR, TIBIAL TRAY, TIBIAL INSERT, AND PATELLA, PLACEMENT OF ANTIBIOTIC-LADEN SPACER.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9837765 ↗
• InjuryFeb 27, 2019Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  CLINICAL DATABASE INFORMATION RECEIVED. PATIENT REPORTS RARE BUT MULTIPLE OCCURRENCES OF SWELLING, JOINT STIFFNESS AND PAIN.

  Patient problems: Edema; Muscular Rigidity; No Code Available; Pain

  MAUDE report 8373416 ↗