ATTUNE 1504-11-103Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295041887), received between Mar 23, 2022 and Mar 23, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 23, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE TKA SURGERY FOR OA. ABOUT 1 MONTH AFTER THE SURGERY, THE PATIENT STARTED TO FEEL PAIN IN THE AFFECTED AREA. THE ALIGNMENT SEEMED TO BE DISORDERED, BUT THE CAUSE OF THE PAIN WAS UNKNOWN, AND IT WAS DECIDED TO PERFORM AN OPEN EXAMINATION OF THE JOINT ON (B)(6) 2022. ON (B)(6) IN THE OPEN EXAMINATION, IT WAS FOUND THAT THE DISTAL FEMUR WAS SINKING. THEREFORE, THE IMPLANT WAS EXCHANGED IN THE REVISION SURGERY. THE BONE SURFACE APPEARED TO HAVE FRAGILITY FRACTURE AND OSTEONECROSIS, BUT THE CAUSE OF THIS CONDITION WAS UNKNOWN. SINCE THE PATIENT WAS FEMALE, IT MAY BE DUE TO OSTEOPOROSIS. THE SURGEON COMMENTED THAT THE EVENT WAS NOT CONSIDERED TO BE IMPLANT RELATED AS THERE WAS NO PROBLEM WITH TIBIA. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2021; DOR: (B)(6) 2022; UNKNOWN KNEE.

  Patient problems: Bone Fracture(s); Necrosis; Pain

  MAUDE report 13860477 ↗