ATTUNE 1511-01-206Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295419600), received between Sep 17, 2019 and Jun 18, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 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 PATIENT WAS STILL INFECTED. THE IMPLANTS WERE REMOVED AND REPLACED WITH NEW COMPONENTS. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 25553472 ↗
• 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 24054321 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED AND SURGEON ELECTED TO REMOVE IMPLANTS AND FUSE KNEE. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23369932 ↗
• 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 22024995 ↗
• InjuryApr 22, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE SURGEON REVISED PATIENT¿S DISTAL FEMORAL REPLACEMENT BECAUSE THE ATTUNE REVISION 50MM FULLY POROUS FEMORAL SLEEVE WAS LOOSE. LOOSENING INTERFACE WAS NON-CEMENTED. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21880621 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTED KNEE. DOI: (B)(6) 2024. DOR: (B)(6) 2024 . AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20352464 ↗
• 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 20034113 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY: (B)(6). 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 20031815 ↗
• InjuryAug 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS BEING TREATED FOR INFECTION. SO, WHETHER THE INFECTION HAD CLEARED SINCE THE DATE OF SURGERY WOULD BE UNLIKELY. HOWEVER, THIS WAS NOT A NEW INFECTION, IT WAS A RECURRENT INFECTION THAT HAS BEEN BEING TREATED FOR YEARS. THE REASON FOR EXCHANGING THE COMPONENTS WAS CONTAMINATION DUE TO THE IMPLANT PERFORATING HIS SKIN.

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

  MAUDE report 12263694 ↗
• 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 10596861 ↗
• InjuryJun 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING A LEFT TOTAL KNEE REVISION. THE SURGEON DID ALL THE PROPER PREPPING FOR A STEM AND SLEEVE FOR THE FEMUR. THE SURGEON OVER REAMED 1MM, AND BROACHED PROPERLY. THE TRIAL CONSTRUCT SAT PERFECTLY. DURING IMPACTION OF THE REAL FEMORAL COMPONENT, THE PATIENT'S FEMUR CRACKED/ BROKE. THE IMPLANT WAS FULLY SEATED BY THE SURGEON, AND THE SURGEON PUT 2 CABLES AROUND THE FEMUR TO STABILIZE THE FRACTURE. THE PRESS FIT BETWEEN THE TRIAL BROACH AND STEM COMPARED THE REAL IMPLANT IS TOO MUCH. THIS CAUSES FRACTURES AND ENDANGERS THE PATIENT. THERE WAS A SURGICAL DELAY OF 15 MINS. DOE: (B)(6) 2020; LEFT KNEE.

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

  MAUDE report 10108905 ↗
• InjurySep 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPACTION OF FEMORAL SLEEVE FINAL IMPLANT AND THE PATIENT'S FEMUR FRACTURES WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES. IF YES, NUMBER OF MINUTES: 5-10 MINUTES. ACTION TAKEN WHEN EVENT OCCURRED? CABLED THE FEMORAL FRACTURE. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? NO.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 9120633 ↗
• InjurySep 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FEMORAL FRACTURE DURING FINAL IMPLANTATION OF FEMORAL CONSTRUCT (FEMUR, SLEEVE, STEM).

  Patient problems: Bone Fracture(s); Not Applicable

  MAUDE report 9078148 ↗