ATTUNE 1549-04-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295383031), received between Dec 2, 2019 and Jun 26, 2026 — classified as 19 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (4 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2026Use of Device Problem

  IT WAS REPORTED THAT SURGEON REVISED A PREVIOUS REVISION FOR BETTER FEMORAL FIT AND POSITIONING. NO PATIENT COMPLICATIONS. THE REPORTER DO NOT HAVE ANY ADDITIONAL INFORMATION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25641795 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED JOINT INSTABILITY FOLLOWING TOTAL KNEE ARTHROPLASTY REVISION, ATTRIBUTED TO MEDIAL COLLATERAL LIGAMENT (MCL) INSUFFICIENCY. THE SURGEON DETERMINED THAT A HINGE PROSTHESIS WOULD BE REQUIRED TO RESTORE STABILITY. FEMORAL SIDE COMPONENTS WERE REMOVED AND A DISTAL FEMORAL PROSTHESIS WAS PLACED WITHOUT DELAY OR HARM. ALL COMPONENTS WERE WELL FIXED AND PERFORMED AS EXPECTED BUT COULD NOT SUPPORT THE LOSS OF STABILITY POST MCL INSUFFICIENCY. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 24730481 ↗
• InjuryApr 22, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6), STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR LOOSENING OF COMPONENTS OF LEFT KNEE, DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: POSSIBLY, PROCEDURE RELATED: POSSIBLY, DATE OF EVENT: 29-JAN-2025, DATE OF IMPLANT: (B)(6) 2020, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: NO INTERVENTION/TREATMENT AT THIS TIME. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150440104, LOT NUMBER ID: J3198U, COMPONENT TYPE: FEMORAL COMPONENT, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 151316110, LOT NUMBER ID: J2332W, COMPONENT TYPE: FEMORAL STEM, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 154904001, LOT NUMBER ID: J32A89, COMPONENT TYPE: FEMORAL MEDIAL POSTERIOR AUGMENT, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 154904002, LOT NUMBER ID: J4629Y, COMPONENT TYPE: FEMORAL LATERAL POSTERIOR AUGMENT, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 150660004, LOT NUMBER ID: 9113354, COMPONENT TYPE: TIBIAL BASE COMPONENT, DEVICE IDENTIFIER: (B)(4). CATALOG NUMBER: 151214030, LOT NUMBER ID: J5202D, COMPONENT TYPE: TIBIAL STEM, DEVICE IDENTIFIER: (B)(4), CATALOG NUMBER: 151302000, LOT NUMBER ID: 8596354, COMPONENT TYPE: FEMORAL STEM OFFSET AD

  Patient problems: Insufficient Information

  MAUDE report 21881990 ↗
• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 20576698 ↗
• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE COMPONENTS WERE REMOVED BECAUSE OF INFECTION. UNKNOWN SURGICAL DELAY. DOI: ON (B)(6) 2024, DOR: ON (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20576675 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS RE-IMPLANTED FOLLOWING THE REMOVAL OF AN ANTIBIOTIC SPACER. PATIENT FELL WHEN THEY GOT HOME THE NEXT DAY CAUSING THE MCL TO BE COMPROMISED. PATIENT WAS BROUGHT BACK FOR SURGERY AND ALL FEMORAL COMPONENTS WERE REMOVED AND A SROM HINGE WAS PLACED. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 19761846 ↗
• MalfunctionJun 4, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SIZE 4 4MM POSTERIOR AUGMENT WOULD NOT SCREW DOWN FLUSH/PROPERLY TO THE FEMORAL COMPONENT. ANOTHER SIZE 4 4MM POSTERIOR AUGMENT WAS OPENED AND IT SCREWED DOWN PROPERLY. THE DEFECTIVE IMPLANT WAS NOT PLACED IN OR AROUND THE PATIENT, IT WAS DISCARDED AFTER THE SURGEON WAS FINISHED ASSEMBLING THE REVISION FEMORAL COMPONENT. DOE: (B)(6) 2024. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19457671 ↗
• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS INFECTED AND ALL COMPONENTS WERE REMOVED AND A SPACED PLACED. NO PATIENT HARM OCCURRED. A POLY EXCHANGE AND I&D WAS PERFORMED ON (B)(6) 2022. DOI- (B)(6) 2022. DOR- (B)(6) 2022. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15902603 ↗
• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS INFECTED AND ALL COMPONENTS WERE REMOVED AND A SPACED PLACED. NO PATIENT HARM OCCURRED. A POLY EXCHANGE AND I&D WAS PERFORMED ON (B)(6) 2022. DOI- (B)(6) 2022. DOR- (B)(6) 2022. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15902599 ↗
• InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A PAINFUL KNEE. DOI: (B)(6) 2019. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15379039 ↗
• InjuryMay 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. NEW FEMUR AND INSERT IMPLANTED. NO FURTHER INFORMATION AVAILABLE. THE CEMENT MANUFACTURER WAS NOT INDICATED. THERE WAS NO REPORTED LOOSENING. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2018, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT.

  Patient problems: Joint Laxity

  MAUDE report 14397432 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INTRAOP BONE FRACTURE - FEMORAL. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. (RIGHT KNEE). TREATMENT: OPEN REDUCTION INTERNAL FIXATION.

  Patient problems: Bone Fracture(s)

  MAUDE report 14083688 ↗
• InjuryApr 11, 2022Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ASPIRATION OF STUDY KNEE (RIGHT) - CONFIRMATION OF LOOSENING TIBIAL COMPONENT. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018, DATE OF EVENT (ONSET): (B)(6) 2021, (RIGHT KNEE). TREATMENT: ASPIRATION OF KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14073471 ↗
• InjuryMar 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ASPIRATION OF STUDY KNEE - AS A RESULT OF RAISED CRP AND INFECTION - CONFIRMATION OF LOOSENING TIBIAL COMPONENT? UNCONFIRMED CURRENTLY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018; DATE OF EVENT (ONSET): (B)(6) 2021 (RIGHT KNEE). TREATMENT: ARTHROSCOPY, ARTHROSCOPIC BIOPSIES TO CONFIRM INFECTED TOTAL KNEE; ASPIRATION/DRAINAGE.

  Patient problems: Unspecified Infection

  MAUDE report 13939557 ↗
• MalfunctionMar 7, 2022Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THIS PATIENT HAD A LEFT TOTAL STRYKER KNEE THAT WAS BEING REVISED TO AN ATTUNE. THE TIBIA AND FEMUR WERE PREPPED PROPERLY WITH STEMS AND SLEEVES. ALL TRIAL CONSTRUCTS SAT PERFECTLY. THE REAL COMPONENTS WERE ASSEMBLED PROPERLY. THE REAL TIBIAL TRAY SAT 3MM PROUD. THE REAL FEMUR SAT 2MM PROUD. THIS CREATED AN IMBALANCE IN FLEXION VERSUS EXTENSION. THERE WAS A SURGICAL DELAY OF FIVE MINUTES. DOE: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13684190 ↗
• MalfunctionMar 7, 2022Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THIS PATIENT HAD A LEFT TOTAL STRYKER KNEE THAT WAS BEING REVISED TO AN ATTUNE. THE TIBIA AND FEMUR WERE PREPPED PROPERLY WITH STEMS AND SLEEVES. ALL TRIAL CONSTRUCTS SAT PERFECTLY. THE REAL COMPONENTS WERE ASSEMBLED PROPERLY. THE REAL TIBIAL TRAY SAT 3MM PROUD. THE REAL FEMUR SAT 2MM PROUD. THIS CREATED AN IMBALANCE IN FLEXION VERSUS EXTENSION. THERE WAS A SURGICAL DELAY OF FIVE MINUTES. DOE: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13684188 ↗
• InjuryJun 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PERSISTING PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS PROBABLY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2020. (LEFT KNEE). TREATMENT: INJECTED AND ORAL MEDICATIONS (UNSPECIFIED), PHYSICAL THERAPY

  Patient problems: Pain

  MAUDE report 11933478 ↗
• InjuryMay 17, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO TREAT INFECTION AND LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS UTILIZED. PATIENT RECEIVED A TEMPORARY SPACER. DOI: (B)(6) 2019. DOR: (B)(6) 2021; UNKNOWN KNEE.

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

  MAUDE report 11838977 ↗
• InjuryMar 19, 2021Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FROM A COMPETITOR TKA TO AN ATTUNE REVISION KNEE. ALL OF THE PROPER PREP AND 1MM OVER REAM OF THE STEMS WAS DONE. THE TRIAL SAT PERFECTLY AND THE REAL IMPLANT WAS CONSTRUCTED TO LOOK EXACTLY LIKE THE TRIALS. THE REAL FEMORAL CONSTRUCT WOULD NOT SEAT FULLY. IT SAT 12MM PROUD AND RESULTED IN THE KNEE BEING MISBALANCED IN FLEXION AND EXTENSION. THERE WAS A 3 MINUTE SURGICAL DELAY.

  Patient problems: Joint Laxity

  MAUDE report 11529227 ↗
• InjuryMar 19, 2021Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FROM A COMPETITOR TKA TO AN ATTUNE REVISION KNEE. ALL OF THE PROPER PREP AND 1MM OVER REAM OF THE STEMS WAS DONE. THE TRIAL SAT PERFECTLY AND THE REAL IMPLANT WAS CONSTRUCTED TO LOOK EXACTLY LIKE THE TRIALS. THE REAL FEMORAL CONSTRUCT WOULD NOT SEAT FULLY. IT SAT 12MM PROUD AND RESULTED IN THE KNEE BEING MISBALANCED IN FLEXION AND EXTENSION. THERE WAS A 3 MINUTE SURGICAL DELAY.

  Patient problems: Joint Laxity

  MAUDE report 11529214 ↗
• InjuryAug 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR KNEE STIFFNESS. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2019. (RIGHT KNEE).

  Patient problems: Muscular Rigidity; No Code Available

  MAUDE report 10378971 ↗
• MalfunctionJun 19, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE SURGEON OVER REAMED 1MM FOR THE FEMORAL STEM, AND BROACHED AND TRIALED APPROPRIATELY. THE REAL FEMORAL CONSTRUCT SAT PROUD AND WOULD NOT FULLY SEAT. IT SAT PROUD 3MM. DUE TO THIS, THE PATIENT HAS A GAP MISBALANCE, AND WILL NOT FULLY EXTEND. THE PRESSFIT FOR THIS CONSTRUCT IS TOO MUCH. UNLESS THE SURGEON PLANS TO BREAK FEMURS TO SEAT FULLY, IT IS VERY DIFFICULT IF NOT IMPOSSIBLE TO SEAT FULLY LIKE THE TRIAL CONSTRUCT SAT. A SURGICAL DELAY OF 20 SECONDS WAS NOTED. DOE: (B)(6) 2020.

  Patient problems: Limited Mobility Of The Implanted Joint; Not Applicable

  MAUDE report 10176538 ↗
• InjuryDec 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR BONE PAIN POST TKR REVISION AT TIBIA AND INFLAMMATION OF ITB AT GERDY'S TUBERCLE. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. DOI: (B)(6) 2018; DOE: (B)(6) 2019 (ONSET); (RIGHT KNEE).

  Patient problems: Inflammation; No Code Available; Pain

  MAUDE report 9396828 ↗