ATTUNE 1547-08-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295382850), received between Dec 20, 2019 and Nov 3, 2025 — classified as 24 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ ASEPTIC LOOSENING. DATE OF EVENT: 06 OCT 2025. DATE OF REVISION: (B)(6) 2025. TREATMENT/IMPACT: REVISION, COMPONENTS REMOVED (FEMORAL, INSERT, TIBIAL), SYNOVECTOMY.

  Patient problems: Insufficient Information

  MAUDE report 23452665 ↗
• InjuryNov 3, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6) STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ ASEPTIC LOOSENING DATE OF EVENT: 06 OCT 2025, DATE OF REVISION: (B)(6) 2025. TREATMENT/IMPACT: REVISION, COMPONENTS REMOVED (FEMORAL, INSERT, TIBIAL), SYNOVECTOMY.

  Patient problems: Insufficient Information

  MAUDE report 23452585 ↗
• InjuryApr 22, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE SURGEON PERFORMED A REVISION OF AN ATTUNE REVISION CONSTRUCT WHICH WAS IMPLANTED ON THE RIGHT SIDE. REASON FOR REVISION WAS DUE TO FEMORAL LOOSENING. THE SURGEON NOTED RADIOLUCENT LINES AROUND THE CEMENTED STEM ON THE FEMORAL COMPONENT. SURGEON USED CMW1. THE SURGEON POINTED OUT THAT CEMENT HAD EXTRUDED PAST THE CEMENT RESTRICTORS (WHICH HE IMPLANTED TWO OF) RESULTING IN AN INADEQUATE CEMENT MANTLE AROUND THE STEM AND PRESSURISATION INTO THE BONE. THE SURGEON ALSO MENTIONED THAT THE PATIENT HAS A PRIMARY KNEE ORIGINALLY WHICH BECAME LOOSE. ALL COMPONENTS WERE REMOVED. THE TIBIA WAS NOT LOOSE AND THE TIBIAL SLEEVE HAD EXCELLENT BIOLOGICAL FIXATION, BUT WAS REVISED AS PARTIAL REVISIONS DON¿T DO AS WELL. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY.

  Patient problems: Insufficient Information

  MAUDE report 21882411 ↗
• InjuryApr 22, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE SURGEON PERFORMED A REVISION OF AN ATTUNE REVISION CONSTRUCT WHICH WAS IMPLANTED ON THE RIGHT SIDE. REASON FOR REVISION WAS DUE TO FEMORAL LOOSENING. THE SURGEON NOTED RADIOLUCENT LINES AROUND THE CEMENTED STEM ON THE FEMORAL COMPONENT. SURGEON USED CMW1. THE SURGEON POINTED OUT THAT CEMENT HAD EXTRUDED PAST THE CEMENT RESTRICTORS (WHICH HE IMPLANTED TWO OF) RESULTING IN AN INADEQUATE CEMENT MANTLE AROUND THE STEM AND PRESSURISATION INTO THE BONE. THE SURGEON ALSO MENTIONED THAT THE PATIENT HAS A PRIMARY KNEE ORIGINALLY WHICH BECAME LOOSE. ALL COMPONENTS WERE REMOVED. THE TIBIA WAS NOT LOOSE AND THE TIBIAL SLEEVE HAD EXCELLENT BIOLOGICAL FIXATION, BUT WAS REVISED AS PARTIAL REVISIONS DON¿T DO AS WELL. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY.

  Patient problems: Insufficient Information

  MAUDE report 21882407 ↗
• InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? NO. B. WERE THERE ANY DEPUY INSTRUMENTATION THAT BROKE DURING SURGERY? IF YES, PLEASE PROVIDE THE DETAILS NO.

  Patient problems: Unspecified Infection

  MAUDE report 20492455 ↗
• InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS HAD MULTIPLE SURGERIES TO TRY AND FIGHT A RECURRING INFECTION. THIS PATIENT HAD REVISION COMPONENTS PLACED (B)(6) 2023. THE INFECTION RETURNED, SO ALL COMPONENTS WERE TAKEN OUT AND AN ANTIBIOTIC CEMENT SPACER WAS PLACED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20492417 ↗
• InjurySep 30, 2024Adverse 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 SEPSIS . DEVICE RELATEDNESS: NO INFORMATION PROVIDED . PROCEDURE RELATEDNESS: NO INFORMATION PROVIDED. DATE OF EVENT: UNK DEC 2024. DATE OF IMPLANT: (B)(6) 2019. DATE OF REVISION : NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: INJECTED MEDICATION.

  Patient problems: Sepsis

  MAUDE report 20333260 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY: DSJ-2016-02 CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION LEFT KNEE (ONGOING) EVENT IS SERIOUS AND IS CONSIDERED SEVERE EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019 DATE OF REVISION: (B)(6) 2020 (I&D WITH TIBIAL INSERT EXCHANGE) DATE OF EVENT (ONSET): 09/08/2020 (LEFT KNEE). TREATMENT: ASPIRATION AND DRAINAGE.

  Patient problems: Unspecified Infection

  MAUDE report 20033498 ↗
• InjuryAug 22, 2024Adverse 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 INFECTION LEFT KNEE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2020, (LEFT KNEE). TREATMENT: SURGICAL IRRIGATION & DEBRIDEMENT, WITH REVISION OF TIBIAL INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 20032992 ↗
• InjuryAug 22, 2024Adverse 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 INFECTION LEFT KNEE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): 07/03/2020. (LEFT KNEE). TREATMENT: SURGICAL IRRIGATION & DEBRIDEMENT, WITH REVISION OF TIBIAL INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 20031730 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY: DSJ-2016-02 CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION LEFT KNEE (ONGOING) EVENT IS SERIOUS AND IS CONSIDERED SEVERE EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019 DATE OF REVISION: (B)(6) 2020 (I&D WITH TIBIAL INSERT EXCHANGE) DATE OF EVENT (ONSET): 09/08/2020 (LEFT KNEE). TREATMENT: ASPIRATION AND DRAINAGE.

  Patient problems: Unspecified Infection

  MAUDE report 20031122 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SEPSIS (STREP B) AND LOOSENING OF THE FEMORAL, SLEEVE AND STEM AT THE CEMENT TO BONE INTERFACE. DEPUY CEMENT WAS USED. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Sepsis

  MAUDE report 14688227 ↗
• InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE PAIN. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018. DATE OF EVENT (ONSET): (B)(6) 2022. (RIGHT KNEE). TREATMENT: KNEE REVISION ON (B)(6) 2022.

  Patient problems: Pain

  MAUDE report 14598013 ↗
• InjuryNov 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT HAS A LONG HISTORY OF LT TKA WITH EXPLANT FOR INFECTION. INITIAL DOS (B)(6) 2020; POLY SWAP (B)(6) 2020; POLY SWAP (B)(6) 2020; POLY SWAP (B)(6) 2020; EXPLANT LEFT TKA WITH ANTIBIOTIC SPACER (B)(6) 2020; ATTUNE LEFT TKA REPLANT (B)(6) 2020; RE-INFECTED WITH EXPLANT AND SPACER (B)(6) 2021 WITH ALL HARDWARE REMOVED. THIS COMPLAINT IS FOR THE 6TH REVISION. DOI: (B)(6) 2020; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12737187 ↗
• InjuryNov 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT HAS A LONG HISTORY OF LT TKA WITH EXPLANT FOR INFECTION. INITIAL DOS (B)(6) 2020; POLY SWAP (B)(6) 2020; POLY SWAP (B)(6) 2020; POLY SWAP (B)(6) 2020; EXPLANT LEFT TKA WITH ANTIBIOTIC SPACER (B)(6) 2020; ATTUNE LEFT TKA REPLANT (B)(6) 2020; RE-INFECTED WITH EXPLANT AND SPACER (B)(6) 2021 WITH ALL HARDWARE REMOVED. THIS COMPLAINT IS FOR THE 6TH REVISION. DOI: (B)(6) 2020; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12737159 ↗
• InjuryOct 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED INDICATED THAT THE PRIMARY OPERATIVE NOTES AND THE FIRST REVISION PROCEDURE NOTES WERE NOT PROVIDED WITHIN THIS SET OF MEDICAL RECORDS. IT IS UNKNOWN, AT THIS TIME, WHAT THE MANUFACTURER OF THE PRIMARY IMPLANTS OR FIRST REVISION SURGERY WERE. UNKNOWN IF DEPUY ¿ DATES OF PRIMARY AND FIRST REVISION SURGERIES ALSO NOT PROVIDED. REVISION OPERATIVE NOTES (B)(6) 2019 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION DUE TO INFECTION. IT IS UNKNOWN IF DEPUY PRODUCTS WERE IMPLANTED AT THIS SURGERY. RE-IMPLANTATION OPERATIVE NOTES (B)(6) 2019 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE RE-IMPLANTATION DUE TO INFECTION MARKERS WERE SATISFACTORY FOR RE-IMPLANTATION. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. REVISION OPERATIVE NOTES (B)(6) 2021 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION DUE TO INFECTION. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. (B)(4). REVISION OPERATIVE NOTES (B)(6) 2021 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION DUE TO PAIN, SWELLING AND HEMATOGENOUS SPREAD OF INFECTION. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURG

  Patient problems: Unspecified Infection

  MAUDE report 12705485 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). THE PATIENT WAS REVISED DUE TO INFECTION. EVERYTHING WAS REMOVED AND STAGE ONE SPACER IMPLANTED. NO LOOSENING AND SURGICAL DELAY NOTED. DOI: (B)(6) 2019. DOR: (B)(6) [201]. LEFT KNEE.

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

  MAUDE report 12438711 ↗
• InjuryApr 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LOW BACK PAIN. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. THERE IS A REMOTE POSSIBILITY THAT THE ADVERSE EVENT IS RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018. DATE OF EVENT (ONSET): (B)(6) 2019. (LEFT KNEE). TREATMENT: RADIATION.

  Patient problems: Pain

  MAUDE report 11744525 ↗
• InjuryApr 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LOW BACK PAIN. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. THERE IS A REMOTE POSSIBILITY THAT THE ADVERSE EVENT IS RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018. DATE OF EVENT (ONSET): (B)(6) 2019. (LEFT KNEE). TREATMENT: RADIATION.

  Patient problems: Pain

  MAUDE report 11744522 ↗
• InjuryNov 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS INFECTION AS A CONSEQUENCE OF PERIPROSTHETIC JOINT INFECTION; SEPTIC MULTI ORGAN FAILURE DUE TO ACUTE PERIPROSTHETIC JOINT INFECTION OF THE LEFT KNEE AND EMPYEMA OF THE RIGHT KNEE AND LEFT SHOULDER. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF REVISION: (B)(6) 2020, (LEFT KNEE). TREATMENT: I&D WASHOUT WITH REVISION OF LEFT KNEE TIBIAL INSERT; ARTHROSCOPY WASHOUT OF RIGHT KNEE AND LEFT SHOULDER.

  Patient problems: No Code Available; Sepsis; Unspecified Infection

  MAUDE report 10831746 ↗
• InjuryNov 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS INFECTION AS A CONSEQUENCE OF PERIPROSTHETIC JOINT INFECTION; SEPTIC MULTI ORGAN FAILURE DUE TO ACUTE PERIPROSTHETIC JOINT INFECTION OF THE LEFT KNEE AND EMPYEMA OF THE RIGHT KNEE AND LEFT SHOULDER DATE OF IMPLANTATION: (B)(6) 2019, DATE OF REVISION: (B)(6) 2020, (LEFT KNEE).

  Patient problems: No Code Available; Sepsis; Unspecified Infection

  MAUDE report 10831714 ↗
• InjurySep 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR FEMORAL FRACTURE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2019, (LEFT KNEE). TREATMENT: OPEN REDUCTION INTERNAL FIXATION.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 10596958 ↗
• InjurySep 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR FEMORAL FRACTURE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2019 (LEFT KNEE). TREATMENT: OPEN REDUCTION INTERNAL FIXATION.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 10596915 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WE HAVE TODAY EXTRACTED AN ATTUNE REVISION CONSTRUCT, DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9505229 ↗