ATTUNE 1504-00-107Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 10603295041085), received between Jun 29, 2017 and Apr 3, 2026 — classified as 1 death, 70 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (11 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 72 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE KNEE WAS BALANCED VERY POORLY. DOI- UNKNOWN. DOR- (B)(6) 2026. AFFECTED SIDE-RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24778379 ↗
• InjuryFeb 24, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO LOOSENING ANTIBIOTIC SPACER. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24433092 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SPACER WAS EXPLANTED FOR INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 24426784 ↗
• InjurySep 15, 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. AFFECTED SITE - LEFT KNEE.

  Patient problems: Pain

  MAUDE report 23053185 ↗
• InjuryJul 29, 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 AND INSTABILITY. AFTER ENTERING THE JOINT, THE PATELLA COMPONENT HAD FAILED AT THE BONE/CEMENT INTERFACE AND WAS FLOATING IN THE JOINT. COMPONENTS SHOWED SIGNS OF LOOSENING ON A BONE SCAN. COMPONENTS WERE REMOVED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22641924 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INCISION AND DRAINAGE WITH POLY EXCHANGE ON (B)(6) 2023 AS WELL AND HAD BEEN FIGHTING DRAINAGE. SURGEON ELECTED TO REMOVE AND PLACE A SPACER. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 22555229 ↗
• InjuryApr 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AT A SKILLED NURSING FACILITY AND RUPTURED HIS RETINACULAR REPAIR AND MCL, CAUSING THE KNEE TO BECOME UNSTABLE. THE SURGEON ELECTED TO CONVERT TO A HINGED PROSTHESIS. DOI: (B)(6) 2024 DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Joint Laxity; Unspecified Tissue Injury

  MAUDE report 19012838 ↗
• DeathFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS ASSOCIATED STUDY: REGISTRY DATE OF EVALUATION: (B)(6) 2024 DATE OF ONSET: (B)(6) 2024 DIAGNOSIS: DEATH ADVERSE EVENT: SPECIFY: COUNTRY: US SERIOUS: YES DEVICE RELATED: DEFINITELY NOT PROCEDURE RELATED: REMOTE POSSIBILITY SUBJECT'S AGE AT ENROLLMENT: 78 SUBJECT'S GENDER: MALE SUBJECT'S HEIGHT: 70 IN SUBJECT'S WEIGHT: 142 LBS (B)(4) ARE RELATED TO EACH OTHER. BOTH COMPLAINTS ARE CREATED FOR THE BILATERAL KNEES. (B)(4) CAPTURE THE LEFT KNEE. (B)(4). CAPTURE THE RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18747408 ↗
• InjuryNov 22, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT TOTAL ATTUNE KNEE WITH A LOOSE TIBIAL TRAY. THE KNEE WAS DONE BY A PRIMARY SURGEON. THE TIBIAL TRAY HAD FALLEN INTO THE VARUS, AND AFTER TAPPING ON THE FEMORAL COMPONENT, IT WAS DISCOVERED THAT IT WAS LOOSE TOO. THESE COMPONENTS WERE REVISED. THE PATELLA WAS WELL FIXED AND RETAINED. SURGICAL DELAY WAS UNKNOWN. THE LOOSENING INTERFACE WAS UNKNOWN AND CEMENT MANUFACTURER WAS UNKNOWN. DOI: (B)(6) 2017; DOR: NOV 13, 2023; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18192258 ↗
• InjuryAug 8, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMUR AT CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17483281 ↗
• InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE KNEE BECAME INFECTED AS THE REASON FOR REMOVAL. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17215817 ↗
• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT IS INFECTED. DR. HAD DONE WASHOUT WITH POLY EXCHANGE PRIOR. PT STILL INFECTED. DR USING ANTIBIOTIC SPACER UNTIL INFECTION CLEARS.

  Patient problems: Unspecified Infection

  MAUDE report 16854738 ↗
• InjuryMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. PATIENT COMPLAINED OF PAIN. BLOOD WORK INDICATED POSSIBLE INFECTION. PATIENT WAS SCHEDULED FOR A I&D WASH OUT AND POLY EXCHANGE. INTRAOP, THE FEMUR CAME OFF WITH NO FORCE. A CEMENT SPACER WITH ANTIBIOTIC¿S WAS IMPLANTED. DOI: (B)(6), 2022 DOR: (B)(6), 2023 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 16637426 ↗
• InjuryMar 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DISRUPTION OF EXTENSOR MECHANISM WITH PATELLAR FRACTURE; EXTENSOR MECHANISM INSUFFICIENCY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE). TREATMENT: IROM BRACE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16597636 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  KNEE INSTABILITY DUE TO LCP FRACTURE. DOI: (B)(6) 2023 DOR: (B)(6) 2023. LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 16551597 ↗
• InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16246478 ↗
• InjuryJan 3, 2023Adverse 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 SERIOUS AND IS CONSIDERED SEVERE. 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: MANIPULATION UNDER ANESTHESIA.

  Patient problems: Adhesion(s)

  MAUDE report 16087834 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR REVISIONS DUE TO PAIN, STIFFNESS, AND ADHESIONS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2020. DATE OF REVISION: (B)(6) 2022. DATE OF EVENT: (B)(6) 2020. (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT AND INSERT WERE REVISED.

  Patient problems: Adhesion(s); Loss of Range of Motion; Muscular Rigidity; Pain

  MAUDE report 15968645 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR REVISION DUE TO INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2021; DATE OF REVISION: (B)(6) 2022; DATE OF EVENT: (B)(6) 2022; (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT AND INSERT WERE REVISED.

  Patient problems: Joint Laxity; Pain; Synovitis

  MAUDE report 15966183 ↗
• MalfunctionOct 11, 2022Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT AFTER REMOVING THE PACKAGING OF THE PROSTHESIS FROM THE CARDBOARD BOX AND HAVING REMOVED THE PROTECTIVE PLASTIC FROM THE OPENING OF THE INTERNAL BOX, THE PROSTHESIS DID NOT COME OUT OF THE CONTAINER DUE TO A SORT OF VACUUM EFFECT. THE PRODUCT HAS BEEN ISOLATED FOR RETURN. NO PATIENT IMPACT/CONSEQUENCES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15580656 ↗
• InjurySep 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: DSJ-2016-03. CLINICAL ADVERSE EVENT RECEIVED FOR LOW GRADE INFECT OF THE LEFT KNEE EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2021. (LEFT KNEE). TREATMENT: IRRIGATION & DEBRIDEMENT WITH REVISION INSERT EXCHANGE ON (B)(6) 2021. REVISION WAS COMPLETED ON (B)(6) 2021 AS TREATMENT FOR THE WORSENING OF THE ORIGINAL INFECTION. CLINICAL DATABASE SPECIFIES FEMORAL STEM, TIBIAL INSERT, TIBIAL BASE, TIBIAL STEM, AND TIBIAL SLEEVE WERE REMOVED. ALL THE PRIMARY IMPLANTS WILL BE CODED FOR INFECTION. THE NEWLY REVISED INSERT WILL NOT BE CODED AS INFECTION AS IT IS NOT LIKELY TO HAVE CONTRIBUTED TO THE ORIGINAL INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 15443184 ↗
• InjuryAug 5, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO ASEPTIC LOOSENING. DATE OF IMPLANT: (B)(6) 2020, DATE OF REVISION: (B)(6) 2022, (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT AND INSERT REMOVED.

  Patient problems: Fall; Insufficient Information; Joint Laxity; Pain; Swelling/ Edema; Synovitis; Unspecified Tissue Injury

  MAUDE report 15174136 ↗
• InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WASH OUT FOR INFECTION. THE LOT#S WERE NOT PROVIDED. LEFT KNEE WASHOUT. 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 REVISION SURGERY OR HARDWARE REMOVAL? YES, FACILITY NAME OF ORIGINAL IMPLANT: (B)(6) MEDICAL CENTER, WAS DEVICE EXPLANTED? TRUE, HARDWARE/EXPLANT REMOVAL DUE TO: SEPTIC KNEE, DID PATIENT REQUIRE REVISION SURGERY? FALSE, PATIENT STATUS/ OUTCOME / CONSEQUENCES: PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC? INFECTION, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES, IF YES, DESCRIBE: REMOVAL OF HARDWARE, IS THE PATIENT PART OF A CLINICAL STUDY : UNKNOWN, ACTIVITY LEVEL: HIGH, (B)(4). DEVICE PROPERTY OF: HOSPITAL, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF -->HOSPITAL, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF: HOSPITAL, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF: HOSPITAL, DEVIC

  Patient problems: Unspecified Infection

  MAUDE report 15115423 ↗
• InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INSTABILITY OF THE PROSTHESIS AFTER POST-FRACTURE OF THE DISTAL FEMUR. SURGICAL PROCEDURE: TOTAL KNEE PROSTHESIS FOR REVISION OF MEDIAL UNICOMPARTMENTAL PROSTHESIS. BETWEEN THE IMPLANTATION OF THE CR ATTUNE DEPUY PROSTHESIS AND THE REVISION THERE WAS A SUPRACONDYLAR PERIPROSTHETIC FRACTURE FROM TRAUMA (NOT CONNECTED TO THE PROSTHESIS OR TO ITS INSTABILITY), WHICH IS TO BE CONSIDERED THE MAIN RESPONSIBLE FOR THE INSTABILITY THAT WE HAVE COME TO TREAT WITH THE REVISION. FOR THE REST, IT WAS A TOTAL EXPLANTATION OF COMPONENTS THAT WERE WELL ADHERED TO THE BONE. DOI: (B)(6) 2019. DOR: (B)(6) 2022. UNKNOWN KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14487592 ↗
• InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DAIR PROCEDURE FOR INFECTED TOTAL KNEE REPLACEMENT. PATIENT IN SEPTIC SHOCK, VERY ILL THOUGHT TO BE A RESISTANT STAPHYLOCOCCUS INFECTION. ORIGINAL PRIMARY SURGERY AT (B)(6) BY DR (B)(6), (B)(6) 2020. NOTHING FURTHER TO REPORT PATIENT AND BOTH SURGEON HAVE NOT CONSENTED TO THE SHARING OF INFORMATION INCLUDING WHAT IS INCLUDED ON THIS DOCUMENT. NO FURTHER INFORMATION AVAILABLE. DOI: (B)(6) 2020. DOR: (B)(6) 2022. UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14469390 ↗