ATTUNE 1504-00-106Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10603295041078), received between Mar 8, 2018 and Mar 9, 2026 — classified as 45 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (7 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.

• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POTENTIAL INFECTION. ATTUNE 6 MONTH.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 24549736 ↗
• InjuryOct 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2025; ATTUNE CR RP 3 MONTH. ALLERGY AFTER 3 MONTHS. GENTAMICIN CHROM.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 23203220 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. ALL IMPLANTS WERE EXPLANTED AND SPACER WAS IMPLANTED. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23075770 ↗
• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEVELOPED AN INFECTION AND NEEDED IMPLANTS REMOVED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23036970 ↗
• InjuryAug 5, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION DUE TO LOOSE FEMORAL COMPONENT. FEMUR FELL INTO VALGUS. PRODUCT STATED TO BE LOOSE: ATTUNE SIZE 6 LEFT CR CEMENTED FEMUR. LOOSENING INTERFACE: BONE TO CEMENT. CEMENT MANUFACTURER: COMPETITOR. DOI: UNKNOWN . DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22719153 ↗
• InjuryJun 24, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION OF ATTUNE PROTHESIS. THE INSERT WAS REMOVED AND APPEARED VERY WORN AND FEMUR WAS LOOSE.

  Patient problems: Insufficient Information

  MAUDE report 22323889 ↗
• InjuryMay 1, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO FEMORAL LOOSENING. DOI: (B)(6) 2022, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21945592 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION CONCERNS. POLY SWAP WAS PERFORMED PRIOR, 8 MONTHS AGO. ALL COMPONENTS REMOVED AND ALL POLY TIBIA AND METAL FEMUR WERE REIMPLANTED ALONG WITH ANTIBIOTIC BEADS. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE. RELATED TO (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 19090786 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS EXPLANTED DUE TO EXPECTED INFECTION. DOI: (B)(6) 2023, DOR: (B)(6) 2024, AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 18476117 ↗
• InjuryDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LATERAL FEMORAL CONDYLE FRACTURED WHILE IMPACTING THE FEMORAL COMPONENT IMPLANT. THE FEMORAL COMPONENT WAS REMOVED CAUSING A SURGICAL DELAY OF 1.5 HOURS. THE SURGEON THEN USED LARGE FRAG SCREWS AND IMPLANTED ATTUNE CRS FEMUR WITH CEMENTED STEM COMPETITOR CEMENT. DOI: UNKNOWN. DOE: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Limb Fracture

  MAUDE report 18252824 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELT A POP DURING REHABILITATION. SURGEON REPAIRED THE PATELLA TENDON AND CHANGED THE INSERT. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17325162 ↗
• InjuryMay 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISED DUE TO INFECTION. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16843108 ↗
• InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INSTABILITY AFTER FALLING. SURGEON CHOSE TO REVISE TO ATTUNE REVISION CONSTRAINED CONSTRUCT. THERE WERE NO REPORTED ISSUES WITH EXPLANTED ITEMS AND NO DELAY IN PROCEDURE. IMPLANTS ARE UNAVAILABLE FOR RETURN. UNABLE TO READ NUMBERS ON POLY AND FEMUR DUE TO DAMAGE DURING EXPLANT AND CEMENT COVERING FEMUR. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 16131839 ↗
• InjuryNov 18, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION COMPLETED DUE TO ASEPTIC TIBIAL AND FEMORAL LOOSENING.

  Patient problems: Insufficient Information

  MAUDE report 15825653 ↗
• InjuryMar 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN BONE CEMENT WAS USED. THE ANATOMIC PATELLA COMPONENT WAS RETAINED DURING REVISION. THE THAT ORIGINAL SURGERY PERFORMED BY DR (B)(6). DOI : (B)(6) 2017, DOR: (B)(6) 2022, AFFECTED SIDE : LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 13720302 ↗
• InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR HYPEREXTENSION FLEXION OF 90 DEGREES. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT HAS A CAUSAL RELATIONSHIP TO DEVICE AND CAUSAL RELATIONSHIP TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021; DATE OF EVENT (ONSET): (B)(6) 2022 (LEFT KNEE). TREATMENT: MANIPULATION UNDER ANESTHESIA.

  Patient problems: Adhesion(s); Joint Laxity

  MAUDE report 13424642 ↗
• InjuryDec 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT KNEE. DOI : UNKNOWN DOR : (B)(6) 2021 LEFT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 12954344 ↗
• InjuryJul 6, 2021Noise, Audible; Noise, Audible

  THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE, ARTHROFIBROSIS, AND DECREASED RANGE OF MOTION. DEPUY CEMENT WAS USED DURING THE PRIMARY OPERATION. AD 18 JUN 2021: LITIGATION RECORD RECEIVED. LITIGATION RECORD ALLEGES SEVERE AND PERSISTENT PAIN, DISCOMFORT, INSTABILITY, POPPING AND CLICKING OF DEVICE, DIFFICULTY AMBULATING, LOSS OF MOBILITY, LOSS OF RANGE OF MOTION, MENTAL ANGUISH, LOOSENING AND MIGRATION OF THE TIBIAL COMPONENT. DOI: (B)(6) 2014, DOR: (B)(6) 2018, LEFT KNEE.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Discomfort; Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 12124256 ↗
• InjuryJun 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A LEFT PRIMARY ATTUNE TKA TO TREAT OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X2 WAS UTILIZED. NO PRIMARY OPERATIVE NOTES WERE PROVIDED. PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT ARTHROFIBROSIS AND TIBIAL TRAY ASEPTIC LOOSENING. PRE-INCISIONAL ROM WAS DECREASED. UPON ENTERING THE JOINT, PERIARTICULAR FIBROUS TISSUE WAS DEBRIDED. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED. THE TIBIAL TRAY WAS GROSSLY LOOSE AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND REVISED. A CONTAINED BONE DEFECT WAS DISCOVERED ALONG THE MEDIAL TIBIAL PLATEAU. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATELLA WAS WELL-FIXED, ALIGNED, AND RETAINED. THE PATIENT WAS REVISED WITH A COMPETITOR REVISION KNEE CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2016. DOR: (B)(6) 2019. LEFT KNEE.

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

  MAUDE report 12032905 ↗
• InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR PATELLA SUBLUXES LATERALLY: ABNORMAL RADIOGRAPHIC EVALUATION. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2017, DATE OF EVENT (ONSET): (B)(6) 2021, (LEFT KNEE). TREATMENT: PHYSICAL THERAPY - FOR PATELLAR STABILIZATION & VMO STRENGTHENING, AND BRACE GIVEN FOR PATELLAR STABILIZATION.

  Patient problems: Joint Laxity

  MAUDE report 12013708 ↗
• InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR LIGAMENT LAXITY IN FLEXION (INSTABILITY). EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2013. DATE OF EVENT (ONSET): (B)(6) 2017. (LEFT KNEE). TREATMENT: PHYSICAL THERAPY.

  Patient problems: Joint Laxity

  MAUDE report 12013498 ↗
• InjuryMar 1, 2021Use of Device Problem; Use of Device Problem

  REVISION OF PRIMARY ATTUNE. FEMUR WAS INTERNALLY ROTATED AND PATELLA WASN¿T TRACKING WELL. FEMUR AND INSERT REMOVED AND REPLACED WITH ATTUNE REVISION FEMUR AND PS FB INSERT. PATELLA WAS ALSO RESURFACED (NOT RESURFACED DURING PRIMARY PROCEDURE). DOI:(B)(6) 2019, DOR: (B)(6) 2021.

  Patient problems: Insufficient Information

  MAUDE report 11393251 ↗
• InjuryJan 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SUBJECT WITH PAIN AROUND PATELLA AFFECTING DAY TO DAY MOBILITY AND ADLS. NO INJURY TO STUDY KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2014. DATE OF EVENT (ONSET): (B)(6) 2020. (LEFT KNEE).

  Patient problems: Pain

  MAUDE report 11207350 ↗
• InjuryJan 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY OPERATIVE NOTES (B)(6) 2015 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED, AND COMPETITOR CEMENT WAS UTILIZED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. REVISION OPERATIVE NOTES (B)(6) 2020 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION DUE TO PAIN AND LOOSENING OF THE TIBIAL COMPONENT. UPON ENTERING THE JOINT, MINIMAL ARTHROFIBROSIS WAS ENCOUNTERED. THE TIBIAL COMPONENT WAS NOTED TO BE LOOSE AT THE CEMENT TO IMPLANT INTERFACE. TIBIAL, FEMORAL AND INSERT COMPONENTS WERE REVISED AND REPLACED WITH COMPETITOR PRODUCT INCLUDING CEMENT. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2015. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: Adhesion(s); Pain

  MAUDE report 11155228 ↗
• InjurySep 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID:(B)(6). STUDY: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR RANGE OF MOTION 0/0/60°. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2014, DATE OF EVENT (ONSET): (B)(6) 2014, (LEFT KNEE). TREATMENT: NONE. PATELLA WAS NOT RESURFACED AT PRIMARY.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 10563819 ↗