ATTUNE 1504-00-108Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10603295041092), received between May 10, 2018 and Apr 22, 2026 — classified as 45 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (6 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 48 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD ACTIVE INFECTION IN THE KNEE JOINT. ALL IMPLANTS WERE REMOVED AND A STAGED ANTIBIOTIC SPACER WAS PLACED. THE BONE HAD BEEN EATEN AWAY BY BACTERIA UNDERNEATH THE IMPLANT. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE-LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24958765 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS INSTABILITY OCCURRED AFTER A FALL. NOT AT THE FAULT OF DR / HOSPITAL/ OR IMPLANT. NO ISSUES WITH DEPUY KNEE PRODUCTS. DOI: (B)(6) 2022, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 23795055 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A LEFT TOTAL KNEE DONE ON (B)(6) 2024. THE KNEE BECAME INFECTED AND THE PATIENT WAS BROUGHT IN FOR RESECTION. ALL COMPONENTS WERE REMOVED AND AN ARTICULATING KNEE SPACER WAS IMPLANTED. THE PROCEDURE WAS COMPLETED WITH NO DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23454308 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A REVISION FOR ANTERIOR KNEE PAIN. THE SURGEON REMOVED ANATOMIC PATELLA / SHAVED DOWN REMAINING BONE / REIMPLANTED DOME PATELLA. CHANGED TO MORE CONSTRAINT POLY AND COMPLETED LATERAL FACETECTOMY. THERE WAS NO DELAY IN SURGERY. IT WAS UNKNOWN IF THE SURGERY WAS DELAYED OR SUCCESSFULLY COMPLETED.

  Patient problems: Pain

  MAUDE report 22903829 ↗
• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL CASE IN REGARDS TO (B)(4). THIS CASE LOGGED TO CAPTURE THE FIRST STAGE REVISION DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 19960723 ↗
• InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE KNEE WAS REVISED.

  Patient problems: Pain

  MAUDE report 19577196 ↗
• InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR POSSIBLE INFECTION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2023 DATE OF EVENT: 06 MAY 2024 (LEFT KNEE) TREATMENT: ASPIRATION.

  Patient problems: Unspecified Infection

  MAUDE report 19342424 ↗
• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS THE FIRST STAGE OF A TWO STAGE KNEE REVISION PROCEDURE DUE TO INFECTION. DURING THIS STAGE, THE PATIENT'S PRIMARY KNEE COMPONENTS WERE REMOVED AND REPLACED BY ANTIBIOTIC CEMENT SPACERS. THERE WAS NO LOOSENING. THE CEMENT MANUFACTURER WAS DEPUY. NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19319661 ↗
• InjuryApr 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT "WAS" REVISED DUE TO INFECTION. REMOVAL OF IMPLANTS AND IMPLANTATION OF SPACER WAS DONE. SURGICAL DELAY UNKNOWN. ACTIVITY LEVEL - YES DOI: (B)(6) 2023 DOR:(B)(6) 2024 AFFECTED SIDE: LEFT KNEE

  Patient problems: Unspecified Infection

  MAUDE report 19180578 ↗
• InjuryJan 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LARGE EFFUSION. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2024. (LEFT KNEE). TREATMENT: ASPIRATION/DRAINAGE.

  Patient problems: Swelling/ Edema

  MAUDE report 18555458 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6) STUDY NO: (B)(6) CLINICAL ADVERSE EVENT RECEIVED FOR BAKER'S CYST. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: ON (B)(6) 2013, DATE OF EVENT: ON (B)(6) 2013, (LEFT KNEE). TREATMENT: US GUIDED ASPIRATION AND STEROID INJECTION.

  Patient problems: Cyst(s)

  MAUDE report 18141155 ↗
• InjuryJul 11, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO FEMORAL LOOSENING OF KNEE. DOI: (B)(6) 2015. DOR: UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17297244 ↗
• InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE. SPACER PLACED WITH ANTIBIOTICS. CEMENT MANUFACTURER WAS COMPETITOR. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17217924 ↗
• InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS A SECOND WASHOUT FOR THIS PATIENT. ALL COMPONENTS WERE REMOVED AND THE JOINT WASH THOROUGHLY WASHED OUT. AN ALL POLY IMPLANT WAS PLACED WITH ANTIBIOTIC CEMENT AS A SPACER. NO OTHER INFORMATION. NO DELAY WAS THERE. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16395688 ↗
• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO INFECTION. DOI: (B)(6) 2021, DOI: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15728858 ↗
• InjuryJun 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO A LOOSE IN FLEXION AND EXTENSION. CEMENT MANUFACTURER WAS NOT INDICATED. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14753397 ↗
• InjuryMar 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION FOR INSTABILITY. DATE OF IMPLANTATION: (B)(6) 2021. DATE OF REVISION: (B)(6) 2021. LEFT KNEE. TREATMENT: REVISION OF TIBIAL INSERT.

  Patient problems: Joint Laxity; Pain

  MAUDE report 13685735 ↗
• InjuryFeb 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DECREASED RANGE OF MOTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021. DATE OF EVENT (ONSET): (B)(6) 2021. (LEFT KNEE) TREATMENT: MANIPULATION UNDER ANESTHESIA.

  Patient problems: Loss of Range of Motion

  MAUDE report 13549441 ↗
• MalfunctionFeb 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EXPLANTED DEVICES: SIZE 7 TIBIA REF 150610007, LOT 8617449; SIZE 8 LEFT CR FEMORAL COMPONENT REF 1504-00-108, LOT DHUDH3; SIZE 8, CR RP REF 5MM REF 1516-30-805, LOT 7907632. THIS PRIMARY HAS BEEN REVISED TODAY DUE TO: TIBIAL SUBSIDENCE AND PAIN, WITH SYNOVITIS. INTRA-OPERATIVELY FOUND: SUSPECTED WEAR OF THE POLY INSERT ; CEMENT DEBRIS EMBEDDED IN POLY PATELLA, AND EMBEDDED IN POSTERIOR SURFACE OF POLY; RP POLY INSERT POSTERIOR SIDE EVIDENCE OF THIRD BODY WEAR.

  Patient problems: Pain; Synovitis

  MAUDE report 13514823 ↗
• MalfunctionOct 26, 2021Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT INTRAOPERATIVELY DURING PRIMARY KNEE-TEP LEFT SIDE THE FEMORAL COMPONENT WAS OPENED AND FOUND TO BE SCRATCHED ON THE SURFACE. ANOTHER IMPLANT WAS AVAILABLE AND USED. NO SURGICAL DELAY, NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12696952 ↗
• InjuryAug 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE. REMOVED FEMUR, TIBIA AND INSERT. ANTIBIOTIC SPACER PUT IN. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12358841 ↗
• InjuryApr 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A LEFT ATTUNE TOTAL KNEE TO TREAT DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED AND COMPETITOR CEMENT X 2 WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO ADDRESS PAIN, ARTHROFIBROSIS, STIFFNESS, LAXITY, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED OSTEOLYSIS BENEATH THE TIBIAL TRAY AND DEBRIDING SIGNIFICANT SCAR TISSUE IN THE KNEE. THE TIBIAL TRAY, TIBIAL INSERT, AND FEMORAL COMPONENT WERE REVISED. THE PATELLAR COMPONENT WAS RETAINED. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS AND CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2015, DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Pain

  MAUDE report 11603215 ↗
• InjuryJan 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT KNEE REVISED FOR PAIN.

  Patient problems: Pain

  MAUDE report 11124430 ↗
• InjuryDec 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS TO CAPTURE THE EVENT REPORTED IN (B)(4). IT WAS REPORTED THAT THE SURGEON PERFORMED THE PATIENT'S ORIGINAL TOTAL KNEE IN (B)(6) OF 2019. AFTER THEIR KNEE SURGERY, THE PATIENT SUFFERED A QUAD TENDON RUPTURE AND NEEDED IT TO BE REPAIRED. DOI: (B)(6) 2019. DOR: NOT KNOWN IF REVISION OCCURRED. LEFT KNEE.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 11058164 ↗
• InjuryDec 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014 PATIENT RECEIVED A LEFT ATTUNE TOTAL KNEE TO TREAT OA. THE PATELLA WAS RESURFACED AND CEMENT MFG IS DEPUY. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. ON (B)(6) 2020 PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO PAIN AND DISCOMFORT. THE PATIENT¿S KNEE ALSO FELT UNSTABLE AND WEAK. CLINICALLY THE KNEE DIDN¿T LOOK INFECTED. PATELLA BAJA WAS NOTED AND WAS CORRECTED AND THE PATELLA WAS RETAINED. THE FEMORAL AND TIBIAL COMPONENT WERE REVISED WITH MINIMAL BONE LOSS. COMPETITOR IMPLANTS AND CEMENT WERE IMPLANTED. DOI: (B)(6) 2017, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: Discomfort; Fatigue; Joint Laxity; Pain

  MAUDE report 10980188 ↗