ATTUNE 1506-11-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10603295416302), received between Mar 7, 2018 and Mar 2, 2026 — classified as 43 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (17 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 43 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED FROM MEDICAL ADVISOR ON 14.04.2026. A LITTLE MORE INFORMATION WAS PROVIDED ON THE CALL TODAY BY DR .(B)(6). I TRIED TO WRITE DOWN AS MUCH AS I COULD, SEE VERBATIM NOTES BELOW. I DON'T HAVE A CLEAR LINK ON WHICH PC THEY RELATE TO AS I DIDN'T GET THE PATIENT NAMES. (B)(4). "ONE LADY WAS PRETTY BIG PERSON - SOLID, SHE WAS DOING OKAY AND HAD A FALL AND KEPT COMPLAINING OF KNEE PAIN FOR A LONG TIME, 15-19 MONTH SHOWED TOO MUCH ACTIVITY ON BONE SCAN, SHE WAS SUBSEQUENTLY REVISED. "JUST A BIT OF ADDITIONAL BONE SCAN ACTIVITY THAT PERSISTED. "ELECTRICAN WENT BACK TO WORK EARLY - AFTER 3M OR LESS THE YWERE BACK TO WORK IT¿S A PHYSICAL JOB IN THE COUNTRY". GOT THE BIOMECHANICS REPORTS - FIBROSIS INGROWTH. "ANOTHER RETIRED CARPENTER - DID WELL FOR 3 MONTHS, JUMPED INTO A POOL AND BOTTOMED OUT. AT THE TIME HE ALMOST VOMITED WITH PAIN. HAD ONGOING DISCOMFORT AND WAS REVISED. "ANOTHER GUY WHO HAD LOOSENING ON FEMUR, RETIRED TOUGH GUY, TOTAL KNEE, WENT ON DO A 1000KM WALK 2-3 MONTHS POST SURGERY. SUFFERED ASEPTIC LOOSENING OF FEMUR. "ANOTHER LADY LATE 60S, SHE KEPT COMPLAINING OF PAIN, WONDERED IF SHE GOT OSTEOPOROSIS. BONE SCAN RESULTS SHOWED ASEPTIC LOOSENING OF

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 24484822 ↗
• InjuryDec 4, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO TIBIAL LOOSENING AT BONE TO IMPLANT INTERFACE AND PATELLA TRACKING. EXPLANTED ATTUNE PRIMARY AND IMPLANTED ATTUNE REVISION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23714975 ↗
• InjuryNov 4, 2025Osseointegration Problem; Osseointegration Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. DARTHMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: REVISION DUE LOOSE TIBIAL TRAY. LOOSENING INTERFACE BONE TO IMPLANT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23463180 ↗
• InjuryJul 30, 2025Osseointegration Problem; Osseointegration Problem

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: THE ATTUNE TIBIAL TRAY WAS REVISED FOR LOOSENING AT AN UNKNOWN INTERFACE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22668632 ↗
• InjuryJul 16, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THERE WAS LOOSENING OF THE TIBIA COMPONENT. LOOSENING INTERFACE WAS NON-CEMENTED. LEADING TO NEED FOR REPLACEMENT TIBIA BASEPLATE AND NEW POLY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22519439 ↗
• InjuryMar 28, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED A POSTOPERATIVE EVENT. ATTUNE TIBIA CEMENTLESS BREAK-DOWN, RIGHT-SIDE. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. IMPLANT DATE: (B)(6) 2023. EXPLANT DATE: (B)(6) 2025. AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21721081 ↗
• InjuryMar 4, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE TIBIA TRAY SHOWED LOSING ON XRAY AND SCAN AT NON-CEMENTED INTERFACE. THE TIBIA TRAY WAS REMOVED AND THE DOCTOR NOTED THAT THERE WAS FIBROUS TISSUE BETWEEN THE TRAY AND BONE. THE TIBIA WAS PREPPED AND A NEW TRAY WAS CEMENTED IN. NEW 10MM POLY WAS ALSO PUT IN. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21514146 ↗
• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2025. IMPLANTS WERE REMOVED DUE TO INFECTION OF THE KNEE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE DUE TO THE SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 21162057 ↗
• InjurySep 18, 2024Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIA AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2020. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20248523 ↗
• InjuryJul 11, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO NON INTEGRATION AND PAIN. AFFECTED SIDE: LEFT.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 19721531 ↗
• InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6), 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 17683728 ↗
• InjurySep 5, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO POTENTIAL LOOSENING OF TIBIA AT UNKNOWN INTERFACE AND KNEE PAIN. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 17682890 ↗
• InjuryFeb 21, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL TRAY AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2020, DOR: (B)(6) 2023, AND AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16409251 ↗
• InjuryFeb 1, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE CEMENTLESS RP BASEPLATE. THE CEMENT MANUFACTURER WAS NOT INDICATED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16278221 ↗
• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. ANTIBIOTIC SPACER WAS IMPLANTED TO STAGE INFECTION. NO OTHER INFORMATION WAS GIVEN. THE CEMENT MANUFACTURER WAS NOT INDICATED. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16252143 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2018. DATE OF REVISION: (B)(6) 2022. (LEFT KNEE). TREATMENT: REVISION; TIBIAL COMPONENT REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 15965923 ↗
• InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT A PRIMARY ATTUNE KNEE REPLACEMENT ON THE (B)(6) 2021 (NO PATELLA RESURFACING DONE DURING PRIMARY SURGERY). THE PATIENT HAS BEEN COMPLAINING OF GROWING ANTERIOR KNEE PAIN AND SOME SWELLING. SURGEON ELECTED TO RE-OPERATE AND RESURFACE THE PATELLA. DURING THIS PROCEDURE IT WAS ALSO NOTED THAT THE PATIENT HAD SIGNIFICANT SYNOVITIS WHICH WAS DEBRIDED AT THE TIME OF SURGERY.

  Patient problems: Inflammation; Pain; Swelling/ Edema; Synovitis

  MAUDE report 15792330 ↗
• InjuryOct 4, 2022Osseointegration Problem; Osseointegration Problem

  REVISION COMPLETED DUE TO LOOSENING OF THE FEMUR AND TIBIA AT BONE TO IMPLANT INTERFACE. SURGEON REVISED THE FEMUR AND TIBIA. DOI: (B)(6) 2020, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15536379 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE ARTHROFIBROSIS. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2021. DATE OF EVENT: (B)(6) 2021. (LEFT KNEE). TREATMENT: NONE.

  Patient problems: Adhesion(s)

  MAUDE report 15162691 ↗
• InjuryMar 25, 2022Osseointegration Problem; Osseointegration Problem

  REVISION COMPLETED DUE TO ASEPTIC LOOSENING OF THE TIBIAL COMPONENT (NON CEMENTED). PATIENT COMPLETED OF PAIN 2 MONTHS POST ORIGINAL PROCEDURE. TIBIA WAS FOUND TO BE LOOSE AND FIBROUS GROWTH. THE ATTUNE PRESSFIT TIBIA WAS REMOVED AND REPLACED WITH A STRYKER TIBIAL CONE AND ATTUNE RP REVISION TIBIA. THE POLY WAS UPSIZED FROM A 7MM TO A 12MM PS. NO SURGICAL DELAY. DOI: (B)(6) 2021 ; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 13904707 ↗
• InjuryMar 23, 2022Osseointegration Problem; Osseointegration Problem

  REVISION COMPLETED TO ADDRESS LOOSENING OF THE TIBIAL TRAY AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2020; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13860650 ↗
• InjurySep 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2020. DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12546311 ↗
• InjuryAug 19, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING AT THE BONE TO IMPLANT INTERFACE. DOI: UNK. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12341631 ↗
• InjuryAug 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO COMPLAINED OF TIBIAL PAIN AND POSSIBLE MEDIAL TIBIAL BASE PLATE LOOSENING AT THE IMPLANT TO BONE INTERFACE. CONVERTED TO SIGMA REVISION KNEE SYSTEM. DOI: (B)(6) 2019 DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Pain

  MAUDE report 12332566 ↗
• InjuryAug 6, 2021Osseointegration Problem; Osseointegration Problem

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE NON CEMENTED TIBIA AT THE IMPLANT TO BONE INTERFACE. THE TIBIA NEVER GREW IN. THE PATIENT DID WELL FOR TWO MONTHS AND THEN STARTED HAVING PAIN. DOI: (B)(6) 2020, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 12289182 ↗