ATTUNE 1511-11-201Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10603295436553), received between Feb 7, 2019 and Jun 18, 2026 — classified as 52 injuries, 1 malfunction.

The most frequently reported specific device problem is “Osseointegration Problem” (3 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 53 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A REVISION PROCEDURE DUE TO PERSISTENT INFECTION FOLLOWING A PREVIOUS TWO-STAGE REVISION. ALL COMPONENTS WERE EXPLANTED AND DISCARDED, AND THEY WERE REPORTED TO BE WELL FIXED AT THE TIME OF REMOVAL. THE PATIENT REQUIRED A CORRECTIVE INVASIVE PROCEDURE IN WHICH THE DEVICES WERE REPLACED OR REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 25552070 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: IT WAS A SPIN-OUT RATHER THAN DISLOCATION. THE INSERT HAD PARTIALLY ROTATED WITHOUT LIFTING OUT OF THE TIBIAL TRAY, AND IT WAS BACK IN THE CORRECT POSITION ON THE FOLLOW UP XRAYS WHEN THE KNEE BRACE HAD BEEN APPLIED.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 22895522 ↗
• InjuryAug 25, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAS A PERSISTENT INFECTION POST TKA UTILIZING REVISION COMPONENTS DUE TO EXTREME DEFORMITY. ALL COMPONENTS WERE REMOVED AND A STATIC SPACER WAS PLACED UTILIZING LPS COMPONENTS FOLLOWING A THOROUGH DEBRIDEMENT. RESORBABLE ANTIBIOTIC BEADS WERE ALSO PLACED. PATIENT HAS HAD MULTIPLE I&DS FOLLOWING THIS PROCEDURE AND DERS WERE SUBMITTED FOR EACH. POROUS COMPONENTS DID NOT SHOW INGROWTH, SUGGESTING THAT THE INFECTION HAS BEEN PRESENT THROUGHOUT CARE. NO ALLEGATION WAS MADE AGAINST ANY COMPONENT. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 22883734 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION OF AN RIGHT ATTUNE TOTAL KNEE REPLACEMENT WHICH WAS DONE (B)(6) 2024. REASON FOR REVISION IS DUE TO INFECTION. COMPONENTS WERE WELL FIXED DESPITE THE DEEP INFECTION. THE SURGEON COMMENTED HOW WELL FIXED THE TIBIAL SLEEVE WAS. ALL COMPONENTS WERE REMOVED. PATIENT HAD A UKR PREVIOUSLY WHICH WAS LOOSED AND WAS REVISED TO THIS. DEPUY PRODUCTS WERE NOT USED IN THE UKR THE SITE WAS DEEMED AS NOT INFECTED AT THE TIME.

  Patient problems: Unspecified Infection

  MAUDE report 22838962 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT'S PRIMARY KNEE WAS DONE. THE PATIENT BEGAN TO HAVE PAIN IN TIBIA. UPON LOOKING AT XRAYS, THE SURGEON DETERMINED THE TIBIAL STEM WAS THROUGH THE LATERAL CORTEX. THE PATIENT UNDERWENT REVISION SURGERY. THE ENTIRE TIBIAL COMPONENT AND POLY WAS REMOVED, A TOTAL OF FIVE IMPLANTS. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 22784558 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT IMPLANT REMOVAL DUE TO INFECTION. DOI: (B)(6) 2025 DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22730699 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ORIGINALLY OPERATED ON FOR AN INFECTED NON-UNION OF FUSION. SINCE CULTURES WERE NEGATIVE, SURGEON CHOSE TO REIMPLANT THE PATIENT. CONTINUED DRAINAGE SUGGESTS INFECTION. SINCE THE PATIENT CONTINUES TO DRAIN DESPITE NEGATIVE CULTURES, THE SURGEON CHOSE TO REMOVE ALL COMPONENTS AND CONVERT TO A STATIC SPACER UTILIZING LPS COMPONENTS, PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS AND HIGH DOSE ANTIBIOTIC CEMENT TO COAT THE COMPONENTS. ALL COMPONENTS WERE WELL FIXED BUT LACK OF BONY INGROWTH ALSO SUGGESTS PERSISTENT INFECTION. AN I&D WAS PERFORMED ON (B)(6) 2025, WHERE THE POLY AND PIN WERE REPLACED. DEPUY 2 WITH GENTAMICIN WAS LIKELY UTILIZED, AS THAT IS THE SURGEON'S NORM. NO DELAY OCCURRED AND NO PATIENT HARM WAS NOTED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22214723 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A POST OPERATIVE HEMATOMA AFTER A COMPLEX PRIMARY KNEE REPLACEMENT UTILIZING REVISION COMPONENTS. ALL COMPONENTS WERE REMOVED AND EXCHANGED UNEVENTFULLY WITH NO PATIENT HARM NOR DELAY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hematoma

  MAUDE report 21944682 ↗
• InjuryMar 5, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO TIBIAL LOOSENING. THE TIBIAL COMPONENTS WERE LOOSE AND THE INTERFACE WAS NON-CEMENTED. AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21530129 ↗
• InjuryJan 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21209307 ↗
• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 20589014 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: (B)(6). CLINICAL ADVERSE EVENTS RECEIVED FOR KNEE STIFFNESS: DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: DEFINITELY; PROCEDURE RELATED: DEFINITELY; DATE OF EVENT: 16 SEP 2024; DATE OF IMPLANT: (B)(6) 2023; DATE OF REVISION: NO INFORMATION PROVIDED; DEVICE LOCATION: LEFT. TREATMENT/IMPACT: PHYSICAL THERAPY; DEPUY SYNTHES PRODUCT USED: COMPONENT TYPE: FEMORAL COMPONENT; CATALOG NUMBER: 150410105; LOT NUMBER ID: 3851774; DESCRIPTION: NO INFORMATION PROVIDED. COMPONENT TYPE: TIBIAL BASE COMPONENT; CATALOG NUMBER: 150680006; LOT NUMBER ID: 4022166; DESCRIPTION: NO INFORMATION PROVIDED. COMPONENT TYPE: TIBIAL STEM; CATALOG NUMBER: 151310110; LOT NUMBER ID: J8383W; DESCRIPTION: NO INFORMATION PROVIDED. COMPONENT TYPE: TIBIAL SLEEVE; CATALOG NUMBER: 151111201; LOT NUMBER ID: J94Z36; DESCRIPTION: NO INFORMATION PROVIDED. COMPONENT TYPE: TIBIAL INSERT COMPONENT; CATALOG NUMBER: 151650505; LOT NUMBER ID: 3787761; UDI: (B)(4). COMPONENT TYPE: CEMENT; CATALOG NUMBER: 3003940002; LOT NUMBER ID: AX42AK0B03; DESCRIPTION: NO INFORMATION PROVIDED.

  Patient problems: Muscular Rigidity

  MAUDE report 20407667 ↗
• InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: (B)(4). CLINICAL ADVERSE EVENTS RECEIVED FOR KNEE STIFFNESS, DEVICE AND PROCEDURE(RELATEDNESS), DEVICE RELATED: DEFINITELY, PROCEDURE RELATED: DEFINITELY, DATE OF EVENT: 16 SEP 2024, DATE OF IMPLANT: ON (B)(6) 2023, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: PHYSICAL THERAPY, DEPUY SYNTHES PRODUCT USED: COMPONENT TYPE: FEMORAL COMPONENT, CATALOG NUMBER: 150410105, LOT NUMBER ID: 3851774, DESCRIPTION: NO INFORMATION PROVIDED. COMPONENT TYPE: TIBIAL BASE COMPONENT, CATALOG NUMBER: 150680006, LOT NUMBER ID: 4022166, DESCRIPTION: NO INFORMATION PROVIDED. COMPONENT TYPE: TIBIAL STEM, CATALOG NUMBER: 151310110, LOT NUMBER ID: J8383W, DESCRIPTION: NO INFORMATION PROVIDED. COMPONENT TYPE: TIBIAL SLEEVE, CATALOG NUMBER: 151111201, LOT NUMBER ID: J94Z36, DESCRIPTION: NO INFORMATION PROVIDED. COMPONENT TYPE: TIBIAL INSERT COMPONENT, CATALOG NUMBER: 151650505, LOT NUMBER ID: 3787761, UDI: (B)(4). COMPONENT TYPE: CEMENT, CATALOG NUMBER: 3003940002, LOT NUMBER ID: AX42AK0B03, DESCRIPTION: NO INFORMATION PROVIDED.

  Patient problems: Muscular Rigidity

  MAUDE report 20407225 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION KNEE REPLACEMENT REVISING ATTUNE CR RP CEMENTED. CONVERTED TO PS RP CEMENTED DOI: (B)(6) 2024 DOE: (B)(6) 2024 ADDITIONAL EVENT DESCRIPTION: PRIMARY (MEDACTA) KNEE HAD INFECTION. REVISED TO SROM HINGE. PERSISTENT INFECTION. RV WASHOUT OF SROM HINGE.

  Patient problems: Unspecified Infection

  MAUDE report 19748898 ↗
• InjuryMay 20, 2024Migration; Migration

  IT WAS REPORTED THAT THIS PATIENT'S KNEE WAS REVISED DUE TO SUBSIDENCE OF HER ATTUNE REVISION TIBIAL BASE COMPONENTS. DURING THIS PROCEDURE, TIBIAL INSERT AND TIBIAL BASE COMPONENTS WERE REMOVED. THEY WERE THEN REPLACED BY NEW ATTUNE REVISION COMPONENTS, TO INCLUDE AN ATTUNE REVISION CONE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19350497 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FOLLOWING IMPLANTS SUBSIDED. RIGHT LPS DISTAL FEMUR, UNIVERSAL FEMORAL SLEEVE, LPS ADAPTER AND UNIVERSAL STEM SUB-SITED LEAVING PATIENTS LEG SHORT ON THAT RIGHT SIDE. ALSO THE ATTUNE REVISION TIBIA, ATTUNE REVISION TIBIAL SLEEVE AND STEM WERE LOOSE. SURGEON EXPLANTED ALL IMPLANTS EXCEPT THE PATELLA. SURGEON REVISED AND REPLACED THE IMPLANTS. THERE WAS LOOSENING OF ALL IMPLANTS AT THE BONE TO CEMENT INTERFACE. DOI: (B)(6) 2023, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Physical Asymmetry

  MAUDE report 19033299 ↗
• InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. SURGEON EXPLANTED THE IMPLANTS. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18960334 ↗
• InjurySep 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO:(B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR LOW BACK PAIN. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2020. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: INJECTED MEDICATION AND PHYSICAL THERAPY, NO REVISION COMPLETED.

  Patient problems: Pain

  MAUDE report 17797666 ↗
• InjuryAug 11, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL CONSTRUCT AT THE BONE TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI: (B)(6) 2019, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 17511027 ↗
• InjuryAug 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  CLINICAL ADVERSE EVENT RECEIVED FOR HEART FAILURE. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2021 . DATE OF EVENT: (B)(6) 2021. (RIGHT KNEE) . TREATMENT: DIAGNOSTIC INTERVENTION COMPLAINT NUMBER: (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 17488481 ↗
• InjuryAug 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2021; DATE OF EVENT: (B)(6) 2021; (RIGHT KNEE) . TREATMENT: ORAL MEDICATION AND PHYSICAL THERAPY COMPLAINT NUMBER: (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

  Patient problems: Pain

  MAUDE report 17488474 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD INFECTED LTKA. SURGEON EXPLANTED THE ATTUNE REVISION IMPLANTS WE IMPLANTED ON (B)(6) 2023. THEY WASHED OUT THE KNEE IMPLANTED JUST A ATTUNE REV FEMORAL COMPONENT AND ATTUNE INSERT ALONG WITH SOME ANTIBIOTIC CEMENT SPACER AND ANTIBIOTIC BEADS. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17368291 ↗
• InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PROVIDED ADDITIONAL INFORMATION VIA EMAIL STATING "YES IT IS MY 2019 KNEE REPLACEMENT THAT HAS COME LOOSE. I AM SCHEDULED FOR RIGHT KNEE REPLACEMENT SURGERY IN OCT. X-RAYS HAVE SHOWN THE FEMORAL PART IS DEFINITELY LOOSE AND IS CAUSING PAIN AND I HAVE PROBLEMS WALKING. PLEASE LET ME KNOW WHEN YOU FIND OUT IF RECALLED AND WHAT CAN BE DONE.

  Patient problems: Ambulation or Postural Difficulties; Cramp(s) /Muscle Spasm(s); Pain; Swelling/ Edema

  MAUDE report 17216589 ↗
• InjuryJun 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION OF AN UNKNOWN ORIGIN. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17153577 ↗
• InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  PATIENT UNDERWENT REVISION FOR INSTABILITY. PATIENT'S PRIMARY WAS WITH COMPETITOR PRODUCTS ON A UNKNOWN DATE. PATIENT HAD FIRST REVISION (REASON UNKNOWN) ON (B)(6) 2022 WHERE OUR PRODUCTS WERE IMPLANTED. PATIENT HAD 2ND REVISION ON (B)(6) 2022 FOR INSTABILITY, (B)(4). THEN A 3RD REVISION FOR INSTABILTY, THIS PC, ON (B)(6) 2023.

  Patient problems: Joint Laxity; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037607 ↗