ATTUNE 1504-00-225Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10603295041283), received between Dec 1, 2017 and Feb 11, 2026 — classified as 47 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (9 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 49 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO GLOBAL INSTABILITY. DOI: (B)(6) 2018, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24316091 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT NEW REVISION DUE TO TIBIA CUT MADE IN VALGUS. PATIENT UNHAPPY WITH ALIGNMENT. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23770635 ↗
• InjuryDec 3, 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 INFECTION. DOI: ON (B)(6) 2023, DOR: ON (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23706457 ↗
• InjurySep 19, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF TIBIAL AND FEMORAL COMPONENTS AT CEMENT TO IMPLANT INTERFACE. PATIENT SHOWED SIGNS OF A LOOSE FEMORAL COMPONENT. COMPETITOR CEMENT WAS USED. DOI: (B)(6) 2018, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23097541 ↗
• InjurySep 4, 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 POOR MOTION. THERE WAS LOOSENING OF THE TIBIA. THE LOOSENING OF THE INTERFACE WAS CEMENTED TO THE IMPLANT. THE CEMENT MANUFACTURER IS UNKNOWN. DOI: ON (B)(6) 2025, DOR: ON (B)(6) 2025, AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Loss of Range of Motion

  MAUDE report 22969881 ↗
• InjuryJan 27, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH THREE KNEE REPLACEMENT DEVICE BY THREE MANUFACTURERS AND ALL THREE DEVICES FAILED. SO FAR PATIENT HAD TWO REVISIONS AND AWAITING A THIRD ONE. ON (B)(6) 2016, THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY WITH DEPUY PRODUCTS. ON (B)(6) 2023, THE PATIENT HAD A REVISION OF THE RIGHT KNEE TO ADDRESS PAIN, LOOSE KNEE, "NEVER FELT RIGHT". ALL DEPUY COMPONENTS WERE REMOVED AND COMPETITOR PRODUCTS WERE PLACED AT THAT TIME. IT WAS FURTHER REPORTED THAT THE PATIENT'S LEFT KNEE WAS IMPLANTED WITH COMPETITOR PRODUCTS.

  Patient problems: Joint Laxity; Pain

  MAUDE report 21242498 ↗
• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REFERRED POST INFECTION TKA. PATEINT WAS ALSO WASHED OUT ON (B)(6) 2024 AND INSERT WAS EXCHANGED. UNFORTUNATELY THIS TREATMENT WAS UNSUCCESSFUL AND A COMPLETE REMOVAL OF HARDWARE WAS REQUIRED. SURGEON CHOSE A ONE STAGE, DUAL SET UP REVISION WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS DUE TO CONSIDERABLE CONCERNS WITH THE PATIENTS SKIN AND ABILITY TO CLOSE HER. THERE WAS NO PATIENT HARM OCCURRED NOR DELAY WAS EXPERIENCED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19270864 ↗
• InjuryApr 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR BONE FRACTURE - FEMORAL. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2024. DATE OF REVISION: (B)(6) 2024. DATE OF EVENT: 25 MAR 2024. (RIGHT KNEE). TREATMENT: FEMORAL COMPONENT, TIBIAL, AND INSERT WERE REVISED.

  Patient problems: Bone Fracture(s)

  MAUDE report 19173944 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OPERATIVE NOTES AD 22 APR 2024 WAS REVIEWED BY CLINICIAN. ON (B)(6) 2024, THE PATIENT HAD A REVISION RIGHT KNEE PERIPROSTHETIC FEMUR FRACTURE TO A FINN HINGED KNEE PROSTHESIS. THE PATIENT HAD A PREVIOUS ARTHROPLASTY 3 WEEKS PRIOR. PRIOR TO THE CURRENT REVISION SURGERY, THE PATIENT REPORTED HAVING INCREASING PAIN AND DISCOMFORT. ALL COMPONENT USED DURING THIS REVISION SURGERY WERE CEMENTED IN USING DEPUY CEMENT.

  Patient problems: Bone Fracture(s); Discomfort; Pain

  MAUDE report 19071862 ↗
• InjuryApr 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED. STATING, THAT THERE WAS NO SURGICAL DELAY REPORTED.

  Patient problems: Fall; Limb Fracture

  MAUDE report 19059023 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELT UNSTABLE. DOI- (B)(6) 2024. DOR- (B)(6) 2024. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18467473 ↗
• InjuryDec 6, 2023Adverse 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 STIFFNESS AND ADHESIONS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Adhesion(s); Muscular Rigidity

  MAUDE report 18276998 ↗
• InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED. A. WHAT IS THE EVENT DATE? -I¿M NOT SURE OF THE EXACT DATE SORRY. PATIENT NOTES ONLY HAD THE YEAR. B. CAN YOU PLEASE CONFIRM THE MANUFACTURER OF THE CEMENT PRODUCT? IF DEPUY, PLEASE PROVIDE THE PRODUCT CODE AND LOT NO. OF THE REPORTED PRODUCT. -THIS SURGEON CURRENTLY USES DEPUY CEMENT, BUT I CAN¿T CONFIRM IF IT WAS USED AT THIS TIME. C. CAN YOU CONFIRM THE PRIMARY SURGERY DATE OR THE ORIGINAL IMPLANTATION DATE? -SORRY PATIENT NOTES ONLY SHOWED THE YEAR, NOT THE EXACT DATE. IMPLANT SCREENSHOTS WHICH I PROVIDED ON A PREVIOUS EMAIL WILL BE WITHIN A DAY OR SO OF (B)(6) 2018 D. WHAT WAS THE REASON FOR DEBRIDEMENT AND MUA IN (B)(6)2019? WAS THERE ANY ADVERSE CONSEQUENCES/SYMPTOMS THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? -REASON FOR MUA AND DEBRIDEMENT WAS DUE TO STIFFNESS AND PAIN. NO ADVERSE CONSEQUENCES NOTED.

  Patient problems: Insufficient Information; Muscular Rigidity; Pain

  MAUDE report 18021588 ↗
• InjuryOct 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE IS LOGGED TO CAPTURE THE PREVIOUS REVISION (2020) MENTIONED IN (B)(4). REVISION OF AN ATTUNE. RIGHT SIDE. PRIMARY WAS DONE IN [YEAR] IN [HOSPITAL] BY [SURGEON]. THEY HAD A DEBRIDEMENT AND MUA IN [YEAR]. REVISION OF THE FEMORAL COMPONENT AND INSERT IN [YEAR]. THIS WAS DONE IN [YEAR] BY [SURGEON]. I¿M NOT SURE WHAT THE PC NUMBER IS FOR THIS. THEY HAVE HAD ONGOING ISSUES SINCE FIRST SURGERY IN [YEAR]. THIS REVISION WAS DUE TO STIFFNESS AND PAIN. UNSURE OF THE LOT NUMBERS FOR THE FEMORAL COMPONENT AND TIBIAL COMPONENT REMOVED. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT?: UNKNOWN. WAS PROCEDURE SUCCESSFULLY COMPLETED?: UNKNOWN. WERE FRAGMENTS GENERATED?: UNKNOWN. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION?: UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES: 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 W

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 18003741 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL OF ATTUNE THAT WAS IMPLANTED (B)(6) 2017. PATIENT SUFFERED INFECTION 2 WEEKS LATER AND SUBSEQUENT BEARING CHANGE FOLLOWED BY YEARS OF STIFFNESS AND INABILITY TO BEND HER KNEE. DISCUSSED WITH SURGEON WHO STATED "THIS IS POST INFECTION STIFFNESS, NOTHING WRONG WITH THE IMPLANT".

  Patient problems: Muscular Rigidity; Unspecified Infection

  MAUDE report 16377718 ↗
• InjuryDec 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A RP POLY INSITU WHICH SPUN OUT TWICE AND WAS UNABLE TO BE REDUCED. MEDIAL COLLATERAL LIGAMENT DAMAGED (FLEXION GAP LOOSE WITH MID FLEXION INSTABILITY). REVISION SURGERY BOOKED FOR CONVERSION TO ATTUNE REVISION CRS WITH HINGE OPTION AVAILABLE. PREPARED FOR ATTUNE REVISION HOWEVER AT TRAILING KNEE WAS STILL UNSTABLE WITH CRS INSERT - LATERAL COLLATERAL STRETCHED. CONVERTED TO SROM HINGE AND GAINED STABILITY.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 16005962 ↗
• InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT'S PRIMARY KNEE WAS INITIALLY REVISED ON (B)(6) 2021 DUE TO INFECTION. DURING THAT PROCEDURE, THE PATIENT'S PRIMARY TIBIAL INSERT WAS REMOVED, HER KNEE WAS IRRIGATED AND DEBRIDED, AND A REPLACEMENT TIBIAL INSERT WAS IMPLANTED. THE PATIENT'S KNEE WAS REVISED A SECOND TIME ON (B)(6) 2022 DUE TO TIBIAL SUBSIDENCE. WHEN THE PATIENT'S LOOSE TIBIAL TRAY WAS REMOVED, THE INTRAMEDULLARY CANAL APPEARED TO BE INFECTED. ALL OF THE PATIENTS KNEE REPLACEMENT COMPONENTS WERE THEREFORE REMOVED AND REPLACED BY A STATIC ANTIBIOTIC SPACER. THERE WAS A REPORTED TIBIAL LOOSENING OF BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. DOI: (B)(6) 2021 (ALL COMPONENTS); (B)(6) 2021 (TIBIAL INSERT). DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15996153 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD 5 OCT 2022 WERE REVIEWED BY CLINICIAN. ON (B)(6) 2017 PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY TO ADDRESS OSTEOARTHRITIS OF THE RIGHT KNEE. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA AND DEPUY CEMENT X2 WERE USED DURING THIS PROCEDURE. THERE WERE NO INTRAOPERATIVE COMPLICATIONS NOTED IN THE OPERATIVE NOTE. ON (B)(6) 2022 THE PATIENT HAD A REVISION TO ADDRESS FAILED RIGHT TOTAL KNEE ARTHROPLASTY. THE INDICATIONS FOR SURGERY INCLUDED: INSTABILITY, AND INTRAOPERATIVE FINDING, PAIN, RECURRENT EFFUSIONS, OF LOOSEN TIBIAL TRAY AT THE IMPLANT TO CEMENT INTERFACE. THE FEMORAL COMPONENT WAS NOTED TO BE WELL FIXED, BUT WAS REMOVED. COMPETITOR COMPONENTS WERE USED DURING THIS PROCEDURE, THE DEPUY PATELLA WAS RETAINED. DOI: (B)(6) 2017; DOR: (B)(6) 2022 (RIGHT KNEE).

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 15672607 ↗
• InjuryJul 29, 2022Use of Device Problem; Use of Device Problem

  PATIENT HAD REVISION KNEE REPLACEMENT FOR PAIN & STIFFNESS. ATTUNE PRIMARY REVISED AND REPLACED WITH ATTUNE REVISION ON (B)(6) 2022. PATIENT HAD ORIGINAL PRIMARY SURGERY IN 2018. AFTER INITIAL PRIMARY SURGERY PATIENT HAD KNEE STIFFNESS WITH LIMITED FLEXION (<90 DEGREES). HAD MULTIPLE (X4) MUA'S (MANIPULATION UNDER UNAESTHETIC) WHICH DID NOT FIX THE ISSUE OF STIFFNESS. X-RAY SHOWED SOME SIGNS OF POSSIBLE TIBIAL LOOSENING (LUCENT LINES & SUBSIDENCE). DURING REMOVAL OF PRIMARY IMPLANTS IN REVISION SURGERY IT WAS NOTED THAT THE FEMUR WAS WELL FIXED BUT WAS SITTING SOMEWHAT ANTERIOR (? PATELLO FEMORAL STUFFING CONTRIBUTING TO STIFFNESS) HOWEVER THE TIBIA WAS SOMEWHAT LOOSE PARTICULARLY ANTERIORLY. FEMUR, TIBIA & INSERT REMOVED. FEMUR DOWNSIZED TO A SIZE 4 TO OPEN FLEXION GAP. FLEXION EXTENSION GAPS EQUALIZED. RP STEMMED FEMORAL & TIBIAL COMPONENT USED WITH POSTERIOR STABILIZED INSERT. KNEE RANGE OF MOTION WAS PAST 90 DEGREES . DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? NO, DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? YES, DID THE PATIENT REQUIRE REVIS

  Patient problems: Loss of Range of Motion; Muscular Rigidity; Pain

  MAUDE report 15131514 ↗
• MalfunctionJun 14, 2022Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE INNER PACKAGING WAS BROKEN ON THE CORNER ON TOP UNDER THE PAPER COVER. DAMAGE WAS DISCOVERED AFTER THE COVER PAPER WAS UNMOVED.

  Patient problems: Insufficient Information

  MAUDE report 14685838 ↗
• InjuryFeb 10, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  ATTUNE FEMUR REVISION DUE TO PAINS AND LOOSENING. DOI: UNKNOWN. DOR: (B)(6) 2022. UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 13506196 ↗
• InjuryDec 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED: (B)(6) 2021. REVISION OPERATIVE NOTES (B)(6) 2020 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REVISION DUE TO PAIN AND LOOSENING. UPON ENTERING THE JOINT, SCAR TISSUE WAS NOTED AND REMOVED. THE TIBIAL COMPONENT WAS NOTED TO BE LOOSE AT THE CEMENT TO IMPLANT INTERFACE. FEMUR, TIBIA AND INSERT REVISED, COMPETITOR PRODUCTS INCLUDING CEMENT IMPLANTED AT THIS REVISION. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2014, DOR: (B)(6) 2020, (RIGHT KNEE).

  Patient problems: Pain; Scar Tissue

  MAUDE report 13112221 ↗
• InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT FELL POST OP AND SPLIT INCISION OPEN. THE PATIENT WAS TREATED NON-OPERATIVELY PREVIOUSLY AND WOULD NOT CLEAR STAPH INFECTION. A HOFFMAN SPACER WAS PLACED. DOI: (B)(6) 2021. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Fall; Unspecified Infection; Wound Dehiscence

  MAUDE report 13046225 ↗
• InjuryMay 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A RIGHT ATTUNE TOTAL KNEE TO TREAT OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. PATIENT RECEIVED A RIGHT KNEE REVISION TO ADDRESS PAIN, INSTABILITY, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE TIBIAL TRAY, TIBIAL INSERT, AND FEMORAL COMPONENT WERE REVISED. THE PATELLAR COMPONENT WAS RETAINED. THE PATIENT WAS REVISED WITH COMPETITOR COMPONENTS AND CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI:(B)(6) 2017. DOR:(B)(6) 2020. RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11792478 ↗
• InjuryFeb 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A RIGHT ATTUNE TOTAL KNEE TO TREAT OSTEOARTHRITIS. THE PATELLA WAS NOT RESURFACED AND COMPETITOR CEMENT WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. PATIENT RECEIVED A RIGHT KNEE REVISION TO TREAT PAIN, INSTABILITY, ADHESIONS, AND TIBIAL TRAY MISPOSITIONING AND LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON REVISED ALL COMPONENTS AND RESURFACED THE PATELLA. THE PATIENT WAS REVISED WITH DEPUY PRODUCTS AND COMPETITOR CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2015, DOR: (B)(6) 2018, RIGHT KNEE.

  Patient problems: Adhesion(s); Joint Laxity; Pain

  MAUDE report 11374961 ↗