ATTUNE 1549-08-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295383130), received between Sep 6, 2019 and Jun 18, 2026 — classified as 22 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A REVISION PROCEDURE DUE TO PERSISTENT INFECTION FOLLOWING A PREVIOUS TWO-STAGE REVISION. ALL COMPONENTS WERE EXPLANTED AND DISCARDED, AND THEY WERE REPORTED TO BE WELL FIXED AT THE TIME OF REMOVAL. THE PATIENT REQUIRED A CORRECTIVE INVASIVE PROCEDURE IN WHICH THE DEVICES WERE REPLACED OR REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 25552457 ↗
• 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 23452676 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD INFECTION IN KNEE AND WAS REVISED DUE TO THAT. THE SURGEON REMOVED ALL COMPONENTS AND PLACED ABX SPACER. NO SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22026049 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CONTINUED TO DRAIN AFTER AN I&D AND POLY EXCHANGE THAT WAS PERFORMED ONE WEEK AND TWO DAYS PRIOR. SURGEON CHOSE TO BRING HIM BACK TO THE OR FOR AN ADDITIONAL WASHOUT AND COMPONENT EXCHANGE. AFTER EXTENSIVE DEBRIDEMENT AND IRRIGATION, SURGEON CHOSE TO EXCHANGE MORE COMPONENTS THAN JUST HE INSERT. SURGEON CHOSE TO EXCHANGE HIS FEMORAL COMPONENT AND AUGMENT. THIS ALLOWED FOR MORE SPACE IN BOTH FLEXION AND EXTENSION AS HIS ROM WAS LIMITED. HE ALSO EXCHANGED HIS PATELLAR COMPONENT. THE PATELLAR COMPONENT WAS FOUND TO BE LOOSE UPON EXAMINATION. CEMENT WAS LIKELY DEPUY 2 WITH GENT. THERE WAS PATELLAR COMPONENT LOOSENING AT BONE/CEMENT INTERFACE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fluid Discharge; Loss of Range of Motion

  MAUDE report 21137749 ↗
• InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR SEPSIS: DATE OF EVENT: UNK DEC 2024. DATE OF IMPLANT: (B)(6) 2019. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: INJECTED MEDICATION.

  Patient problems: Sepsis

  MAUDE report 20333263 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: DSJ-2016-02. 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 20031310 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY: (B)(4). 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): (B)(6) 2020. (LEFT KNEE). TREATMENT: ASPIRATION AND DRAINAGE.

  Patient problems: Unspecified Infection

  MAUDE report 20031178 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY: (B)(4). 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 20031023 ↗
• 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 20030934 ↗
• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUSPECTED PROSTHETIC INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 18950551 ↗
• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUSPECTED PROSTHETIC INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 18950518 ↗
• 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 12737103 ↗
• 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 12736974 ↗
• 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 SUR

  Patient problems: Unspecified Infection

  MAUDE report 12705680 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPASS CASE (B)(4) REPORT: 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 12438722 ↗
• 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 10596928 ↗
• 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 10596888 ↗
• InjuryJun 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. PATIENT HAD A RT TKA REVISION ON (B)(6) 2019, AND THEN HAD ANOTHER REVISION WITH POLY CHANGE ON (B)(6) 2019 EXCHANGING A PS RP INSERT FOR A CRS INSERT (MDR CASE NUMBER (B)(4)). THE SURGEON WANTED TO REMOVE THE SIZE 8 CRS FEMUR AND PUT IN EITHER A SIZE 9 OR 10 TO LOSE THE FLEXION GAP. THE SURGEON REMOVED THE FEMORAL COMPONENT. THE FEMORAL SLEEVE AND STEM STAYED IN THE FEMUR. THE SURGEON THEN TRIALED USING A SIZE 9 AND 10 FEMUR TO CLOSE THE FLEXION GAP. THE SURGEON FELT THAT THE SIZE 10 FEMUR WOULD BE THE BEST OPTION. IMPLANTS WERE OPEN ALONG WITH AUGMENTS. THE SURGEON CEMENTED THE FEMORAL COMPONENT IN PLACE AND FELT LIKE A SIZE 10 CRS 20 MM INSERT GAVE THE BEST STABILITY IN EXTENSION AND FLEXION. NO SURGICAL DELAY. DOI: (B)(6) 2019, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10206837 ↗
• 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 9505233 ↗
• InjurySep 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENTS LEFT KNEE WAS REVISED WITH AN I & D AND POLY EXCHANGE DUE TO INFECTION. DOI: (B)(6) 2019, DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9071392 ↗
• InjurySep 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE KNEE BECAME REINFECTED. DOI: (B)(6) 2019, DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8971946 ↗
• InjurySep 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE KNEE BECAME REINFECTED. DOI: (B)(6) 2019. DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8971942 ↗