NA 86-7424Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295217886), received between Apr 23, 2018 and Dec 2, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Fracture” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2025Fracture; Fracture

  IT WAS REPORTED THE HEALTH CARE PROFESSIONAL REPORTED EVENT TO BFARM DIRECTLY: IT WAS REPORTED A FRACTURE OF FEMORAL SLEEVE/STEM WITHOUT TRAUMA OCCURRED POST-OPERATIVELY WHILE PATIENT WAS WALKING THE DOG. DOI: (B)(6) 2020, DOR: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692986 ↗
• InjuryJul 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS FRACTURE BELOW THE TIBIA IMPLANT AND LOOSENING OF THE TIBIAL COMPONENT AT THE UNKNOWN INTERFACE. UNKNOWN CEMENT WAS USED. IT WAS REPORTED THAT THE TC3 AND MBT TRAY COMPONENTS WERE EXPLANTED, THE FRACTURE WAS REDUCED AND PLATED BY ANOTHER SURGEON. AN ATTUNE REVISION CONSTRUCT WAS IMPLANTED IN PLACE. NO SURGICAL DELAY. DOI: (B)(6) 2021; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 12127530 ↗
• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE KNEE WAS OPENED AND THE OLD SROM HINGED COMPONENTS REMOVED AND THESE WERE REPLACED WITH AN ATTUNE REVISION TRAY (AS FULLY POROCOATED TIB SLEEVES ARE AVAILABLE) A CROSSOVER ATTUNE LPS BEARING UTILIZED (AVAILABLE ON SAS) AND A FRESH S ROM HINGE IMPLANTED, ALONG WITH A NEW PATELLA COMPONENT. REMOVAL OF ALL COMPONENTS DUE TO FUNGAL INFECTION ,

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

  MAUDE report 11705680 ↗
• InjuryMar 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS PERIPROSTHETIC KNEE INFECTION. NO DELAY IN SURGERY. DOI: (B)(6) 2019, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 11398521 ↗
• InjuryMay 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT FELL AT PHYSICAL THERAPY AND FRACTURED ENTIRE DISTAL FEMUR AROUND EXISTING SROM HINGE COMPONENT. ABLE TO KEEP THE TIBIAL COMPONENT BUT REMOVED THE SROM FEMUR AND PUT IN AN LPS. NO X RAYS AVAILABLE. DOI: (B)(6) 2019 DOR: (B)(6) 2019 LEFT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 8584891 ↗
• InjuryApr 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7450258 ↗