ATTUNE 1504-01-207Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10603295041504), received between Oct 12, 2018 and Aug 25, 2026 — classified as 33 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Femur was revised for pain. Affected Side: Right Knee.

  Patient problems: Pain

  MAUDE report 50429732 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that Patient was being revised due to infection.DOI: (b)(6), 2024DOR: (b)(6), 2026Affected side: Left Knee

  Patient problems: Unspecified Infection

  MAUDE report 50208988 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DUE TO THE FEMORAL COMPONENT DISLODGING AND ROTATING ANTERIORLY, THE KNEE WAS REVISED IN ITS ENTIRETY. THE FEMORAL COMPONENT, TIBIAL COMPONENT AS WELL AS POLY INSERT WERE REMOVED FROM THE PT. AND FIELD, THERE WAS NO DELAY TO THE CASE NOR HARM DONE TO THE PATIENT. THERE WAS AN ATTEMPT TO SALVAGE THE PRIMARY CONSTRUCT, BUT THERE WAS NO WAY TO RECONSTRUCT THE FEMUR PROPERLY. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25394880 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. ALL COMPONENTS WERE REMOVED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 25019600 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. ANTIBIOTIC SPACER WAS PLACED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24530493 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD ASEPTIC REVISION DUE TO PAIN. DOI- (B)(6) 2023. DOR- (B)(6) 2026. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24221599 ↗
• InjuryJan 26, 2026Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT HAD KNEE PAIN AND FLEXION CONTRACTURE. FEMUR WAS REMOVED, ALIGNMENT AND ROTATION WERE CHANGED. PATELLA IMPLANT WAS IMPLANTED TO A PREVIOUSLY NATIVE PATELLA. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain; Septic loosening

  MAUDE report 24183750 ↗
• InjurySep 3, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO FEMUR AND TIBIA LOOSENING AT UNKNOWN INTERFACE. PATIENT REPORTED PAIN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 22954463 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNSTABLE AND SURGEON DECIDED TO EXPLANT AND REVISE ALL COMPONENTS. THERE WAS NO DELAY OR COMPLAINTS. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22579744 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THEY EXPLANTED THE INFECTED KNEE, WITH THE PLACEMENT OF ANTIBIOTIC SPACER. THERE WERE NO ADVERSE CONSEQUENCES OR DELAYS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21527822 ↗
• InjuryJan 15, 2025Loss of or Failure to Bond; Osseointegration Problem; Loss of or Failure to Bond; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TOTAL KNEE REPLACEMENTS ON (B)(6) 2023. BOTH OF THE PROSTHETICS FAILED TO ADHERE AND WERE COMPLETELY LOOSE HAVING SUBSEQUENT SURGERIES. THE PATIENT EXPERIENCED PAIN, LIMITED MOBILITY, AND COMPLICATIONS. THIS COMPLAINT, (B)(4), CAPTURES THE TKR RIGHT ON (B)(6) 2024. THIS PRODUCT COMPLAINT IS RELATED TO (B)(4), WHICH CAPTURES THE TKR RIGHT ON (B)(6) 2023.

  Patient problems: Inadequate Osseointegration; Loss of Range of Motion; Pain

  MAUDE report 21157932 ↗
• InjuryDec 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD AN EXPLANT SURGERY DUE TO PCL COMPROMISE. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21000181 ↗
• InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DOTS: CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION-DEEP / POSSIBLE INFECTION SEEDED FROM SINUS INFFECTION. DEVICE RELATEDNESS: POSSIBLY. PROCEDURE RELATEDNESS: DEFINITELY NOT. DATE OF EVENT: 22/NOV/2024. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: NO INFORMATION PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 20914182 ↗
• MalfunctionDec 6, 2024Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE IMPLANT WAS STUCK IN PACKAGING. SURGEON COULD NOT REMOVE IT AND THEREFORE WASTED THE FEMUR IMPLANT. SURGICAL DELAY WAS UNKNOWN. DOE: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20867215 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT ON (B)(6).2024, THE PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT, SYNOVECTOMY, PLACEMENT OF STIMULANT PELLETS AND POLY SWAP OF THE RIGHT KNEE DUE TO A DEEP INFECTION. THERE WAS SOME SOFT TISSUE BREAKDOWN MEDIALLY REQUIRING ADDITIONAL STITCHES TO ENSURE THE WOUND WAS CLOSED APPROPRIATELY. THE PATIENT WAS GIVEN IV ANTIBIOTICS AFTERWARDS.

  Patient problems: Fluid Discharge; Hypersensitivity/Allergic reaction; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20543575 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A VRAS ROBOTIC KNEE DONE ON (B)(6) 2024. PATIENT HAD COMPLAINED OF STIFFNESS AND LACK OF ROM. PATIENT WAS MANIPULATED WHICH WAS UNSUCCESSFUL. DOCTOR REVISED PATIENT'S FEMUR TO HELP WITH ROM. DOWNSIZED FEMUR, REMOVED PATELLA, ADFIXIUM BASEPLATE WAS WELL FIXED (RETAINED). OTHER COMPONENTS WERE REMOVED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 20345828 ↗
• InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO POOR RANGE OF MOTION. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(4) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 19343526 ↗
• MalfunctionApr 8, 2024Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT ON (B)(6) 2024, WHEN THE IMPLANT IN QUESTION WAS OPENED, THE LID STUCK AND DID NOT PEEL OFF, AND THE IMPLANT IN QUESTION WAS TAKEN OUT BY CUTTING IT WITH A SCALPEL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19067952 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  KNEE TEP SURGERY, RIGHT LEG, ON (B)(6) 2023 AT HOSPITAL. SINCE THEN RASHES AND OTHER INTOLERANCES.

  Patient problems: Hypersensitivity/Allergic reaction; Rash; Swelling/ Edema

  MAUDE report 18749491 ↗
• InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 18661811 ↗
• InjuryJun 13, 2023Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE AFFECTED SIDE INVOLVED IN THIS EVENT WAS THE RIGHT SIDE.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inadequate Osseointegration

  MAUDE report 17116403 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR GI BLEED. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: BLOOD GIVEN; PANTOPRAZOLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16815062 ↗
• InjuryMar 9, 2023Osseointegration Problem; Osseointegration Problem

  REVISION COMPLETED DUE TO INFECTION AND LOOSENING OF THE FEMUR AND TIBIA AT THE BONE TO IMPLANT INTERFACE. PATIENT HAS A PERI PROSTHETIC JOINT INFECTION AND A STAGE 1 ANTIBIOTIC SPACER WAS IMPLANTED. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16512338 ↗
• InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. DURING THE FIRST REVISION PROCEDURE ON (B)(6) 2022, HIS PRIMARY TIBIAL INSERT WAS REMOVED, HIS KNEE WAS THOROUGHLY IRRIGATED AND DEBRIDED, AND A REPLACEMENT INSERT WAS IMPLANTED. FIRST REVISION SURGERY WAS CAPTURED IN PC-(B)(4). DURING THE SECOND REVISION PROCEDURE, ALL OF THE PATIENT'S IMPLANTS WERE REMOVED AND REPLACED BY AN ANTIBIOTIC SPACER. DOI: (B)(6) 2022 (TRAY, FEMORAL AND PATELLA) AND (B)(6) 2022 (INSERT). DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16246509 ↗
• InjuryDec 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTED TOTAL KNEE AFTER APPROXIMATELY 3-4 WEEKS. SURGEON REMOVED PRESSFIT FEMUR AND TIBIA AND AOX INSERT. THE SURGEON PERFORMED AND IRRIGATION AND DEBRIDEMENT AND CEMENTED IN A PS FEMUR AND ALL POLY STABILIZED INSERT. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15942434 ↗