ATTUNE 1547-05-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 10603295382744), received between Dec 20, 2019 and Sep 25, 2026 — classified as 52 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (5 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 52 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50904651 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR FRACTURE (MEDIAL FEMORAL CONDYLE), DEVICE AND PROCEDURE (RELATEDNESS), DEVICE RELATED: POSSIBLY, PROCEDURE RELATED: DEFINITELY, DATE OF EVENT: 01 MAR 2018, DATE OF IMPLANT: ON (B)(6) 2018, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: RIGHT, TREATMENT/IMPACT: NONE: YES, DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 66017569, LOT NUMBER: 87094695, COMPONENT TYPE: CEMENT, DESCRIPTION: NO INFORMATION PROVIDED, CATALOG NUMBER: 150440205, LOT NUMBER: HC1433, COMPONENT TYPE: FEMORAL COMPONENT, DESCRIPTION: ATTUNE KNEE SYSTEM REVISION CRS FEMORAL CEMENTED RIGHT SIZE 5, CATALOG NUMBER: 151216080, LOT NUMBER: H44164, COMPONENT TYPE: FEMORAL STEM, DESCRIPTION: ATTUNE KNEE SYSTEM REVISION CEMENTED STEM 16X80MM, CATALOG NUMBER: 151820038, LOT NUMBER: 8695634, COMPONENT TYPE: PATELLA, DESCRIPTION: ATTUNE PATELLA MEDIALIZED DOME 38MM CEMENTED AOX, CATALOG NUMBER: 150640004, LOT NUMBER: 8641298, COMPONENT TYPE: TIBIAL BASE COMPONENT, DESCRIPTION: ATTUNE KNEE SYSTEM REVISION FIXED BEARING TIBIAL BASE CEMENTED SIZE 4, CATALOG NUMBER: 151700512, LOT NUMBER: H66856, COMPONENT TYPE: TIBIAL INSERT COMPONENT, DESCRIPT

  Patient problems: Limb Fracture

  MAUDE report 24802033 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO FRACTURE ABOVE THE REVISION COMPONENTS. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Limb Fracture

  MAUDE report 24618409 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO FRACTURE ABOVE THE REVISION COMPONENTS. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Limb Fracture

  MAUDE report 24618407 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO THE REMOVAL OF IMPLANTS FOR INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24327409 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POSSIBLE INFECTION OF REVISION RTKA THAT WAS IMPLANTED (B)(6) 2024. REMOVED ALL IMPLANTS AND WASHED OUT AND PERFORMED A 1 1/2. STAGE REVISION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24054645 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN INFECTION. SURGEON REMOVED IMPLANTS AND PLACED AN ANTIBIOTIC SPACER. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22968147 ↗
• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR PAIN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 22853701 ↗
• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR PAIN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 22853623 ↗
• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO A CEMENT SPACER DUE TO INFECTION - ALL REVISION COMPONENTS WERE REMOVED AND CEMENT SPACER PLACED WHILE PATIENT WAS ON ANTIBIOTICS IN THE HOPES SHE WOULD CLEAR THE INFECTION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22828056 ↗
• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO A CEMENT SPACER DUE TO INFECTION: ALL REVISION COMPONENTS WERE REMOVED AND CEMENT SPACER PLACED WHILE PATIENT WAS ON ANTIBIOTICS IN THE HOPES SHE WOULD CLEAR THE INFECTION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22828051 ↗
• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POSTOPERATIVELY, A FRACTURE OCCURRED POST REVISION SURGERY, THIS WAS BELIEVED TO BE CAUSED DUE TO THE HIGH BMI. FRACTURE OCCURRED IN THE FEMUR ABOVE THE STEM, THIS IS BELIEVED TO HAVE OCCURRED AFTER THE TOURNIQUET WAS REMOVED AND THE LEG MOVED POST OP. THE PATIENT WAS TRANSFERRED TO HAVE PLATING COMPLETED TO REPAIR THIS.

  Patient problems: Bone Fracture(s)

  MAUDE report 22703162 ↗
• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POSTOPERATIVELY, A FRACTURE OCCURRED POST REVISION SURGERY, THIS WAS BELIEVED TO BE CAUSED DUE TO THE HIGH BMI. FRACTURE OCCURRED IN THE FEMUR ABOVE THE STEM, THIS IS BELIEVED TO HAVE OCCURRED AFTER THE TORNIQUET WAS REMOVED AND THE LEG MOVED POST OP. THE PATIENT WAS TRANSFERRED TO HAVE PLATING COMPLETED TO REPAIR THIS.

  Patient problems: Bone Fracture(s)

  MAUDE report 22703141 ↗
• InjuryMar 7, 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 ASEPTIC LOOSENING. DATE OF IMPLANT: (B)(6) 2018. DATE OF REVISION: (B)(6) 2025. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: REVISION.

  Patient problems: Insufficient Information

  MAUDE report 21549419 ↗
• InjuryJan 24, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING. LOOSENING INTERFACE WAS MENTIONED AS NOT APPLICABLE. THE CEMENT MANUFACTURER WAS DEPUY. NO SURGICAL DELAY. DOI: (B)(6) 2018. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21233035 ↗
• InjuryJan 24, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING. LOOSENING INTERFACE WAS MENTIONED AS NOT APPLICABLE. THE CEMENT MANUFACTURER WAS DEPUY. NO SURGICAL DELAY. DOI: (B)(6) 2018 DOR: (B)(6), 2025 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21232900 ↗
• InjuryJan 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21210222 ↗
• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID:: (B)(6). STUDY NO: DSJ_2016_02 CLINICAL ADVERSE EVENTS RECEIVED FOR INSTABILITY. DATE OF EVENT: 24 OCT 2019 DATE OF IMPLANT: (B)(6) 2019 DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: LEFT. TREATMENT/IMPACT: HOSPITALIZATION AND CLOSED REDUCTION/MANIPULATION.

  Patient problems: Joint Laxity

  MAUDE report 20535443 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD KNEE REVISION FROM NEXGEN TO ATTUNE REVISION ON (B)(6) 2020. HAS PRESENTED WITH INSTABILITY AND X-RAY SHOWS THE TIBIA HAS SUBSIDED. CONCERNED WITH INTEGRITY OF THE MEDIAL AND LATERAL COLLATERAL LIGAMENTS THE PATIENT HAS HAD KNEE REVISED ONCE AGAIN FOR A HINGE.

  Patient problems: Joint Laxity

  MAUDE report 20057021 ↗
• InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION: DATE OF REVISION: (B)(6) 2025. TREATMENT/IMPACT: REVISION OF STUDY JOINT, HOSPITALIZATION AND ATTUNE TIBIAL INSERT.

  Patient problems: Pain

  MAUDE report 19701920 ↗
• InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION: DATE OF REVISION: (B)(6) 2025. TREATMENT/IMPACT: REVISION OF STUDY JOINT, HOSPITALIZATION AND ATTUNE TIBIAL INSERT.

  Patient problems: Pain

  MAUDE report 19701911 ↗
• InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR WORSENING OF RIGHT SHIN PAIN LEADING TO POLY EXCHANGE AND PATELLAR RESURFACING. TREATMENT/IMPACT: HOSPITALIZATION, INJECTED MEDICATION, REVISION OF STUDY JOINT.

  Patient problems: Pain

  MAUDE report 19346016 ↗
• InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED. AND IT MENTIONED, THAT THE TREATMENT/IMPACT USED, WAS THE FULL KNEE REVISION, USING ATTUNE PS FB.

  Patient problems: Pain

  MAUDE report 19345964 ↗
• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INSTABILITY IN FLEXION. DOCTOR DECIDED THAT WE WERE NOT GOING TO BE ABLE TO MAKE A CRS INSERT WORK WITH JUST BALANCING. HE DECIDED A HINGED KNEE WAS NECESSARY. WHILE REMOVING THE ATTUNE SLEEVE HE ENCOUNTERED MORE BONE LOSS THAN HE HOPED AND DECIDED THAT A DISTAL FEMORAL REPLACEMENT WAS NECESSARY. HE WOULD HAVE LIKED TO BE ABLE TO PUT A HINGED KNEE INTO THE ATTUNE REV SLEEVE. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 16203372 ↗
• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INSTABILITY IN FLEXION. DOCTOR DECIDED THAT WE WERE NOT GOING TO BE ABLE TO MAKE A CRS INSERT WORK WITH JUST BALANCING. HE DECIDED A HINGED KNEE WAS NECESSARY. WHILE REMOVING THE ATTUNE SLEEVE HE ENCOUNTERED MORE BONE LOSS THAN HE HOPED AND DECIDED THAT A DISTAL FEMORAL REPLACEMENT WAS NECESSARY. HE WOULD HAVE LIKED TO BE ABLE TO PUT A HINGED KNEE INTO THE ATTUNE REV SLEEVE. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 16203370 ↗