ATTUNE 1506-11-007Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 10603295416296), received between Aug 24, 2018 and Aug 11, 2026 — classified as 74 injuries, 1 malfunction.

The most frequently reported specific device problem is “Osseointegration Problem” (29 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 25 most recent of 75 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 50208989 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 50173274 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem; Noise, Audible

  ADDITIONAL INFORMATION RECEIVED: A. PLEASE PROVIDE THE DATE OF EVENT. - PATIENT PRESENTED IN CLINIC FOR ONE YEAR FOLLOW UP. B. PLEASE CONFIRM WHETHER THE REVISION SURGERY COMPLETED ON (B)(6) 2026? KNEE SCOPE DONE ON (B)(6). NO EVIDENCE OF ANYTHING IN JOINT SPACE. REVISION SURGERY NOT REQUIRED. C. PLEASE CONFIRM THE AVAILABILITY OF EXPLANTS- DISCARDED OR STILL AVAILABLE? REVISION SURGERY NOT REQUIRED, NO EXPLANT. D. CT SCAN- DENSE MASS IN THE CENTER OF THE DISTAL FEMUR - IS THIS RELATED TO PATIENT FACTORS OR IMPLANT RELATED? WHAT WAS SURGEON'S OPINION? - SURGEON IS UNCLEAR WHAT THIS WAS, OR IF IT WAS METAL ARTEFACT ON IMAGE OR IF ANYTHING. UNABLE TO SEE ANYTHING DURING KNEE SCOPE. PATIENT WAS UNABLE TO REPRODUCE "AUDIBLE CLICK" DURING CLINIC APPTS PRE KNEE SCOPE. SURGEON DECIDED NOT TO PROCEED WITH OPEN SURGERY.

  Patient problems: Pain

  MAUDE report 25047344 ↗
• 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- (B0(6) 2026. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24221494 ↗
• InjurySep 18, 2025Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THERE WAS AN ATTUNE CEMENTLESS TIBIA LOOSENING AND SUBSIDENCE AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23089240 ↗
• InjurySep 2, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING. TIBIAL BASEPLATE AND FEMORAL COMPONENT WERE LOOSE AT NON-CEMENTED INTERFACE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22939306 ↗
• InjuryJul 14, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE RP PRESSFIT TIBIA LOOSENED. THE SURGEON REVISED FULL CONSTRUCT SINCE IT WAS PUT IN ANATOMICAL ALIGNMENT. THE SURGEON USED REVISION METALS AND WENT TO MECHANICAL ALIGNMENT. LOOSENING INTERFACE: NON-CEMENTED. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22494120 ↗
• InjuryFeb 5, 2025Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WERE NO REPORTED DELAYS. THEY ALSO CONFIRMED LOOSENING WAS A BONE IMPLANT INTERFACE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21315520 ↗
• InjuryJan 9, 2025Migration; Migration

  IT WAS REPORTED THAT THE TIBIAL BASEPLATE SUBSIDED AND RESULTED IN INSTABILITY. BASEPLATE WAS REMOVED AND REPLACED WITH ATTUNE REVISION HARDWARE. THERE WAS NO WEAR ON THE POLY. THE IMMEDIATE POST-OP FILMS OF THE IMPLANT LOOKED GOOD, THEN SHIFTED LATER. THE SURGEON FELT THEY WERE SIZED APPROPRIATELY. THERE WAS NO EXCESSIVE RESECTION OF THE FEMUR OR TIBIA IN THE PRIMARY SURGERY. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21114746 ↗
• InjuryDec 31, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THE ATTUNE SIZE 7 CEMENTLESS TIBIAL TRAY WAS REVISED DUE TO PAIN AND A SUBSEQUENT BONE SCAN SHOWED A ¿HOT¿ SPOT ON THE POSTERIOR ASPECT OF THE TIBIAL TRAY. THE TRAY ORIGINALLY IMPLANTED IN (B)(6) 2022. THE KNEE WAS REVISED ON (B)(6) 2024 . NO BONE IN GROWTH OR ON GROWTH EVIDENT ON THE TRAY WHEN EXPLANTED AND THE TRAY WAS EXPLANTED QUITE EASILY. NO BONY EVIDENCE ON THE EXPLANTED TRAY.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 21047872 ↗
• InjuryNov 5, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF THE TIBIAL INSERT AND TIBIAL TRAY DUE TO NON-CEMENTED LOOSENING OF THE TIBIAL TRAY. SURGEON PERFORMED REPLACEMENT OF THE TIBIAL TRAY AND INSERT. SURGICAL DELAY WAS UNKNOWN. DOI: ON (B)(6) 2022, DOR: ON (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20609085 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? NO. B. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? NO. C. WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NO.

  Patient problems: Joint Laxity

  MAUDE report 20350849 ↗
• InjuryJul 10, 2024Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT THE TIBIAL TRAY WAS COLLAPSED LATELY. NO CEMENT WAS USED ON TIBIAL TRAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19709866 ↗
• InjuryApr 29, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE TIBIAL WAS LOOSENING: FEMUR TIBIA AND POLY WERE EXPLANTED HOWEVER, ONLY TO GAIN ACCESS TO THE TIBIA.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19202014 ↗
• InjuryApr 25, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: TIBIAL COMPONENT LOOSE(UNKNOWN INTERFACE) AND PAIN

  Patient problems: Pain

  MAUDE report 19180417 ↗
• InjuryMar 27, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAD A POSSIBLE INFECTION OF LEFT TOTAL KNEE. THE SURGEON EXPLANTED THE FOUR IMPLANTS AND PERFORMED WASH OUT AND I&D. THEN PERFORMED 11/2 STAGE REVISION ALONG WITH ANTIBIOTIC CEMENT AND BIOCOMPOSITES. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 18987889 ↗
• InjuryFeb 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ATTUNE CEMENTLESS IMPLANTS WERE REMOVED DUE TO INFECTED KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18769375 ↗
• 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 18661921 ↗
• InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PTG IMPLANTED ON (B)(6) 2022. ALWAYS PAINFUL DESPITE PHYSIOTHERAPY. TOTAL PTG REPLACEMENT DOI: (B)(6) 2022.. DOE: (B)(6) 2024. AFFECTED SIDE: LEFT.

  Patient problems: Pain

  MAUDE report 18596122 ↗
• 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)(6) 2019. DOR: (B)(6) 2021 AFFECTED SIDE: LEFT.

  Patient problems: Joint Laxity; Pain; Unspecified Tissue Injury

  MAUDE report 18356904 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6), 2020. DOR: (B)(6), 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 18038056 ↗
• 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. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17832692 ↗
• InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY AND PAIN. DOI: UNKNOWN . DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 17683607 ↗
• InjuryJun 19, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  A CEMENTLESS CR RP ATTUNE KNEE WAS REVISED FOR BEING LOOSE. THE BONE SCAN SHOWED THE FEMUR WAS LOOSE, AND UPON EXPLANTATION A PSEUDO MEMBRANE WAS PRESENT BETWEEN IMPLANT AND IMPLANT AND BONE INTERFACE. X RAYS SPOOKED NORMAL. NO EXPLANTED INFORMATION IS AVAILABLE DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? --> UNKNOWN, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? - UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES - YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?- REVISION SURGERY REQUIRED, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: - UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY - UNKNOWN, (B)(4). DEVICE PROPERTY OF - NONE, DEVICE IN POSSESSION OF - NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.- TRUE

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction

  MAUDE report 17151624 ↗
• MalfunctionMay 31, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE IMPLANTS FOR THE CASE WERE OPENED ON THE BACK TABLE AND THE SCRUB TECH OPENED THE TOP PAPER WRAP FOR THE TIBIAL BASE PLATE. SHE NOTICED A HAIR SITTING ON TOP OF THE SPONGE PACKAGING OVER THE TIBIAL IMPLANT. THEY REMOVED ALL THE PACKAGING AND IMPLANT FROM THE BACK TABLE AND OPENED UP ANOTHER TIBIAL BASE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17032012 ↗